[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AstraZeneca\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":717},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,277,0,25,[9,53,81,121,154,186,214,247,269,299,334,353,375,401,427,448,470,496,543,570,595,620,652,676,695],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100609951","phase-3-a-study-of-rilvegostomig-or-durvalumab-plus-chemotherapy-for-first-line-treatment-of-biliary-tract-cancer-artemide-biliary02-100609951",false,"NCT07221253","A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)","Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)","AB02","Key inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).\n* Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting\n* Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.\n* Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.\n* ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS \\> 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.\n* Adequate bone marrow and organ function.\n\nKey exclusion Criteria:\n\n* Ampullary carcinoma\n* Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.\n* Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.\n* Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.\n* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n* Active or ongoing interstitial lung disease\u002Fpneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.","ALL","18 Years",{"count":21,"type":22},1100,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.",[28],"Biliary Tract Cancer",[30,31,28,32,33,34,35,36,37,38,39],"Rilvegostomig","Durvalumab","Bispecific Antibody","PD-L1","TIGIT","Initially Unresectable","Recurrent","Intra-hepatic cholangiocarcinoma","Extra-hepatic cholangiocarcinoma","Gallbladder cancer","RECRUITING","2026-08-20",{"date":43,"type":44},"2026-08-21","ACTUAL",{"date":46,"type":44},"2025-12-04",{"date":48,"type":22},"2029-07-31",{"name":50,"class":51},"AstraZeneca","INDUSTRY",177,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":61,"minAge":19,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100589314","phase-3-a-study-of-metastases-free-survival-with-saruparib-vs-placebo-added-to-a-standard-rtadt-in-men-with-high-risk-prostate-cancer-with-a-brca-mutation-100589314","NCT06952803","A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT\u002FADT in Men With High-risk Prostate Cancer With a BRCA Mutation","A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).","EvoPAR-PR02","Inclusion Criteria:\n\n* Male participants with a histologically documented diagnosis of prostate adenocarcinoma.\n* Newly diagnosed high-risk and very high-risk (localised\u002Flocally advanced) prostate cancer or a high-risk biochemical recurrence (BCR) following radical prostatectomy.\n* Provision of a formalin fixed and paraffin embedded (FFPE) tumour tissue sample.\n* Confirmed BRCA1 or BRCA2 mutation status by central tumour tissue is required for enrolment.\n* Participants required to have a computed tomography (CT) or magnetic resonance imaging (MRI) and a bone scan following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).\n* Participants required to have a prostate-specific membrane antigen-positron emission tomography (PSMA-PET) following the completion of their planned RT. This screening scan must confirm no evidence of disease or evidence of disease confined to the pelvis (M0).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomization.\n* Minimum life expectancy of 12 months.\n* Adequate organ and bone marrow function as described in study protocol.\n* All participants will have received either primary or salvage RT. Participants must be eligible for randomisation within 10 months of initial diagnosis (de novo or BCR). Radiotherapy administered to the prostate (± pelvis) either in the primary or salvage setting must be delivered with curative intent. Use of metastases-directed therapy, as part of the RT radiation plan, is permitted as localised RT treatment for a metastatic lesion(s) outside the pelvis.\n* All participants will have received a planned regimen of ADT with a gonadotropin releasing hormone (GnRH) analogue.\n* Participants must not father children or donate sperm from signing informed consent form (ICF), during the study intervention and for 6 months after the last dose of study intervention.\n* Participants must use a condom (with spermicide - where permitted) from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.\n\nExclusion Criteria:\n\n* Participants with a history of myelodysplastic syndrome (MDS)\u002F acute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML.\n* Participants with any known predisposition to bleeding \\[e.g., active peptic ulceration, recent (within 6 months) hemorrhagic stroke, proliferative diabetic retinopathy\\].\n* Any history of persisting (\\> 2 weeks) severe cytopenia due to any cause.\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib and\u002For abiraterone.\n* History of another primary malignancy, with exceptions.\n* Persistent toxicities \\[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2\\] caused by previous anticancer therapy.\n* Cardiac criteria, including history of arrhythmia and cardiovascular disease.\n* Evidence of active and uncontrolled hepatitis B and\u002For hepatitis C.\n* Evidence of active and uncontrolled human immunodeficiency virus (HIV) infection.\n* Active tuberculosis infection.\n* Any prior chemotherapy (i.e., docetaxel) or immunotherapy; any prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor.\n* Prior treatment within 14 days with blood product support or growth factor support.\n* Concomitant use of strong inducers and inhibitors of CYP3A4 (applies to saruparib and abiraterone) or herbal supplements within 21 days or at least 5 half-lives (whichever is longer), of randomization.\n* Concomitant use of drugs that are known to prolong QT and have a known risk of Torsades de Pointes (TdP).\n* Participants with a known hypersensitivity to saruparib or any excipients of these products.","MALE",{"count":63,"type":22},700,[25],"The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised\u002Flocally advanced prostate cancer with a breast cancer gene mutation (BRCAm).",[67],"Prostate Cancer",[69,70,71,72,73],"Localised\u002Flocally advanced prostate cancer","High-risk biochemical recurrence (BCR)","Poly (ADP-ribose) polymerase","Radiation therapy or radiotherapy","Breast cancer gene (BRCA) mutation",{"date":43,"type":44},{"date":76,"type":44},"2025-08-06",{"date":78,"type":22},"2036-04-30",{"name":50,"class":51},346,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100500508","phase-1-phase-iiia-study-of-azd5335-as-monotherapy-and-combination-therapy-in-participants-with-solid-tumors-100500508","NCT05797168","Phase I\u002FIIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors","A Modular Phase I\u002FIIa, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors","FONTANA","Core Inclusion Criteria:\n\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Participants who do not provide informed consent for Optional Genetic Research may still be enrolled in the study.\n* Participant must be ≥ 18 years at the time of signing the informed consent.\n* Willing to provide adequate archival and\u002For baseline tumor sample as applicable per module-specific criteria.\n* For participants who have previously received targeted therapies such as ADCs, a fresh baseline biopsy will be required unless the most recent archival tissue sample was collected after receipt of such treatment.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and\u002For tolerability to prior therapy. Participants with contraindications or who refuse therapy in accordance with local practice may also be considered provided that it is documented that he\u002Fshe was informed about all therapeutic options.\n* Participants must have measurable disease per RECIST v1.1,\n\n  1. A previously irradiated lesion can be considered a target lesion if the lesion is progressing and well defined.\n  2. For participants who undergo biopsies at screening and\u002For on treatment, it is preferred though not required, that the biopsied lesion, be distinct from any target lesion used in the RECIST v1.1 evaluation.\n* Life expectancy ≥ 12 weeks.\n* Adequate organ and marrow function.\n* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n  (a) Male participants: (i) Male participants who are sexually active with a female partner of childbearing potential must use a male condom (plus an additional contraceptive method) post-screening for at least 8 months following the last dose of study intervention. It is strongly recommended for the female partner of a male participant to also use a highly effective method of contraception throughout this period. In addition, male participants must refrain from freezing or donating sperm while on study and for 8 months following the last dose of study intervention.\n\n  (b) Female participants : (i) Females of childbearing potential must have a negative serum pregnancy test result within 72 hours prior to receiving the first dose of study intervention and a negative urine or serum pregnancy test prior to starting their next cycle of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n(ii) (ii) Sex and Contraceptive\u002FBarrier Requirements: Highly effective birth control methods include: Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) \\[(periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception\\], a vasectomized partner, Implanon®, bilateral tubal occlusion, intrauterine device\u002Flevonorgestrel intrauterine system, Depo Provera™ injections, oral contraceptive associated with inhibition of ovulation, and Evra Patch™, Xulane™, or NuvaRing®.\n\nFemale participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly), from enrolment throughout the study and for 8 months following the last dose of study intervention. The male partner of a female participant of childbearing potential must also use a male condom (plus spermicide, if available) throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. In addition, female participants must not donate or retrieve for their own use, ova while on study and for 8 months following the last dose of study intervention.\n\nCore Exclusion Criteria:\n\n* Patients with spinal cord compression or a history of leptomeningeal carcinomatosis.\n* Patients with brain metastases unless, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \\> 10 mg prednisone\u002Fday or equivalent for at least 4 weeks prior to first dose of study intervention.\n* Treatment with any of the protocol defined medications, without adequate washout periods or time before the first dose of study intervention.\n* Unresolved toxicities of Grade ≥ 2 (National Cancer Institute \\[NCI\\] CTCAE v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy). Participants with stable ≤ Grade 2 neuropathy are eligible.\n* Active infection, including tuberculosis and infections with hepatitis B virus (HBV; verified by known positive hepatitis B surface antigen \\[HBsAg\\] result), hepatitis C virus (HCV) or known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥ 350\u002Fmm3, no history of acquired immune deficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen).\n\nPatients with a past or resolved HBV\u002FHCV infection are eligible if:\n\n1. Negative for HBsAg and positive for anti-hepatitis B virus core protein (HBc) or\n2. Are HBsAg + with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below:\n\n(i) HBV DNA viral load \\\u003C100 IU\u002FmL. (ii) Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C3 x upper limit of normal (ULN), which are not attributable to HBV infection.\n\n(iii) Start or maintain antiviral treatment if clinically indicated as per the Investigator or as per local guideline.\n\nNote for Japan: Japanese patients with positive anti-HBs\u002Fanti-HBc and negative HBsAg will be assessed following local guidelines.\n\n(c) Participants testing positive for HCV antibody are eligible only if the polymerase chain reaction test result is negative for HCV RNA.\n\n* Patient has active ILD\u002Fpneumonitis or has a history of (non-infectious) ILD\u002Fpneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n\n  * Patients with a history of radiation pneumonitis which has clinically and radiologically resolved and not requiring treatment with steroids may be eligible.\n* History of another malignancy except for:\n\n  * Malignancy treated with curative intent and with no known active disease for at least 2 years prior to screening of study intervention and with low potential risk for recurrence.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated carcinoma in situ without evidence of disease.\n  * Localized non-invasive solid organ primary disease under surveillance.\n* Patients with any of the following cardiac criteria:\n\n  * History of arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, and ventricular tachycardia), which is symptomatic or requires treatment NCI CTCAE v5.0 Grade 3 except for:\n\n    (i) Rate controlled asymptomatic atrial fibrillation.\n    * NOTE: significant abnormalities in serum electrolytes that can increase the risk of arrhythmic events (ie, sodium, potassium, calcium, and magnesium) should be corrected before starting the study intervention.\n  * Uncontrolled hypertension.\n  * Acute coronary syndrome\u002Facute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months of screening.\n  * History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.\n  * Symptomatic heart failure (as defined by New York Heart Association class ≥ 2).\n  * Prior or current diagnosis of cardiomyopathy considered clinically relevant per investigator's judgement.\n  * Severe uncorrected valvular heart disease.\n  * Mean resting QTcF \\> 470 msec obtained from triplicate electrocardiograms (ECGs) and averaged, recorded within 5 minutes.\n  * Any factor that, in the opinion of the investigator, increases the proarrhythmic risk of QT prolongation, such as congenital long QT syndrome, family history of long QT syndrome, hypertrophic cardiomyopathy, or unexplained sudden cardiac death under 40 years of age.\n* Uncontrolled and\u002For unresolved intercurrent illness within 12 months prior to screening, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, or illness (including psychiatric illness) and\u002For social situations, in the opinion of the investigator, that would limit compliance with study requirements and activities, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.\n* Substance abuse or any other medical conditions that would increase the safety risk to the participant or interfere with participation of the participant or evaluation of the clinical study in the opinion of the Investigator.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants, if enrolled, should not receive live vaccine whilst receiving study intervention and up to 3 months after the last dose of study intervention. Participants can receive Coronavirus (COVID)-19 vaccines, at the discretion of the Investigator, following a benefit\u002Frisk evaluation for the individual participant and in accordance with local rules and regulations and vaccination guidelines. Note: If a COVID-19 vaccine is administered it should be done \\> 72 hours prior to study intervention initiation or after completion of the DLT period.\n* For women only - currently pregnant (confirmed with positive pregnancy test or suspected), lactating, breastfeeding, or intention to become pregnant during the study period.\n* Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study. Exception: Diagnostic imaging evaluation studies (e.g. PET) may be allowed subject to case-by-case discussion with the Sponsor.\n* Patients with a known hypersensitivity to study intervention or any of the excipients of the product.\n* Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n* Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Previous enrolment in the present study. \\*\\*Other module specific criteria may apply","130 Years",{"count":91,"type":22},602,[93,94],"PHASE1","PHASE2","This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors",[97,98,99,100],"Ovarian Cancer","Lung Adenocarcinoma","Endometrial Cancer","Lung Squamous Cell Carcinoma",[102,103,104,105,106,107,108,109,110,111,112,113,97,98,99,100],"ADC","PARP inhibitor","AZD5335","Torvutatug Samrotecan","Torvu-sam","AZD5305","Saruparib","Bevacizumab","Carboplatin","AZD9574","Palacaparib","Pembrolizumab",{"date":43,"type":44},{"date":116,"type":44},"2023-06-05",{"date":118,"type":22},"2028-08-04",{"name":50,"class":51},60,{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":23,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100443987","phase-2-neoadjuvant-and-adjuvant-treatment-in-resectable-non-small-cell-lung-cancer-100443987","NCT05061550","Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer","A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)","NeoCOAST-2","Inclusion Criteria:\n\n* Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).\n* WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and bone marrow function.\n* Provision of tumour samples (newly acquired or archival tumour tissue \\[≤ 6 months old\\]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.\n* Adequate pulmonary function.\n\nExclusion Criteria:\n\n* Participants with sensitising EGFR mutations or ALK translocations.\n* Participants with baseline PD-L1 expression status \\\u003C1% (Arms 6 and 7 only).\n* Active or prior documented autoimmune or inflammatory disorders.\n* Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement.\n* History of another primary malignancy.\n* Participants with small-cell lung cancer or mixed small-cell lung cancer.\n* History of active primary immunodeficiency.\n* History of non-infectious interstitial lung disease (ILD) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* Participants who have preoperative radiotherapy treatment as part of their care plan.\n* Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.\n* QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.\n* Any medical contraindication to treatment with chemotherapy as listed in the local labelling.\n* Participants with moderate or severe cardiovascular disease.\n* Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.\n* Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-TIGIT (T cell immunoreceptor with Ig and ITIM domains), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.\n* Active or uncontrolled infections including HBA, HBV, HCV, and HIV.","95 Years",{"count":131,"type":22},630,[94],"The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.",[135],"Non-small Cell Lung Cancer",[137,138,31,139,140,141,142,143,144,145,146,30],"Lung Cancer","early-stage","Oleclumab","Monalizumab","AZD0171","Datopotamab Deruxtecan","Neoadjuvant","Adjuvant","Chemotherapy","Volrustomig",{"date":43,"type":44},{"date":149,"type":44},"2022-04-14",{"date":151,"type":22},"2030-05-28",{"name":50,"class":51},97,{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":161,"sex":18,"minAge":19,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100648496","phase-1-a-study-to-investigate-the-relative-bioavailability-and-safety-of-different-oral-formulations-of-elecoglipron-in-healthy-participants-100648496","NCT07723833","A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants","A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants","Inclusion Criteria:\n\n* Healthy participants with suitable veins for cannulation or repeated venipuncture.\n* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.\n* Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.\n* Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.\n* Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.\n* Have a body mass index between 18.5 and 30 kg\u002Fm2 inclusive and weigh at least 50 kg.\n\nExclusion Criteria:\n\n* History of any clinically important disease or disorder.\n* History of acute pancreatitis.\n* History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.\n* Any clinically important illness, medical\u002Fsurgical procedure, or trauma.\n* Participants who have previously received elecoglipron within the last 3 months.",true,"55 Years",{"count":164,"type":22},152,[93],"The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.",[168],"Healthy Participants",[170,171,172,173,174,175,176,177],"Glucagon-like peptide receptor agonist (GLP-1RA)","Type 2 Diabetes Mellitus (T2DM)","Glucose Metabolism Disorders","Metabolic Diseases","Obesity management","Pharmacokinetics","Relative bioavailability","Obesity and Related Co-morbidities","2026-08-19",{"date":41,"type":44},{"date":181,"type":44},"2026-07-27",{"date":183,"type":22},"2026-11-18",{"name":50,"class":51},2,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100626028","phase-3-a-study-to-evaluate-the-treatment-outcomes-of-subcutaneous-anifrolumab-in-immunosuppressant-nave-and-biologic-nave-systemic-lupus-erythematosus-100626028","NCT07430306","A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus","Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)","SUNFLOWER","Inclusion Criteria:\n\n1. Males or females aged 18 to 70 years of age.\n2. Participants who have a diagnosis of SLE confirmed by a rheumatologist.\n3. ANA-positive per the Central Lab at screening:\n\n   (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)\n4. Must be on the standard therapy regimen: antimalarials with or without OCSs\n5. Must have at screening and baseline:\n\n   1. Clinical SLEDAI-2K ≥ 4 points OR\n   2. Clinical SLEDAI-2K \\\u003C 4 with GC dose ≥ 7.5 mg\u002Fday (prednisone equivalent)\n6. Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis \\[TB\\]) or previous TB\n7. Should have no evidence of malignancy; and clinically significant abnormalities (unless due to SLE).\n8. No medical history or signs or symptoms of active TB prior to or during Screening.\n9. Body weight ≥ 40.0 kg\n10. Negative pregnancy test for females during screening\n11. Normal HPV test result within 2 years prior to Week 0 (Day 1).\n12. Willing and able to participate in all required study evaluations and procedures including completion of PROs.\n13. Willing to not use any other forms of experimental treatment during the study.\n\nExclusion Criteria:\n\n1. Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.\n2. Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio \\[INR\\] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE.\n3. Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded.\n4. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.\n5. Subjects with a history of 3 or more unexplained consecutive pregnancy losses.\n6. History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia Suicide Severity Rating Scale (C SSRS) at Screening.\n7. Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, protocol-specified standard therapy is insufficient.\n8. Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient.\n9. Current diagnosis of, catastrophic antiphospholipid syndrome (APS).\n10. History of recurrent infection requiring hospitalization and IV antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks).\n11. Known History of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV at Screening.\n12. Confirmed positive test for hepatitis B.\n13. Any clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.\n14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1).\n15. Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the ICF (chronic nail infections are allowed).\n16. Severe HZ or recurrent HZ.\n17. Malignancy. History of cancer, apart from:\n\n    (a) Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1).\n\n    (a) Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).\n18. Received any SLE-related therapies other than antimalarials and GCs.\n19. History of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.\n20. History of an anaphylactic reaction to human proteins or mAbs.\n21. Received any live or attenuated vaccine within 8 weeks prior to signing the ICF.\n22. Blood transfusion or receipt of blood products except albumin.\n23. Received more than 2 investigational products for the SLE since time of diagnosis.\n24. Received any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater.\n25. Concurrent enrollment in another clinical study with a study intervention.\n26. Subjects with any abnormal lab result as specified in the protocol.\n27. Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.).\n28. Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease.\n29. Subject with non-SLE concomitant illness, as determined by medical judgment, who is likely to require additional systemic glucocorticosteroid therapy during the study (e.g., asthma).\n30. Any condition would interfere with treatment outcomes of the study intervention or put participant at safety risk.\n31. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 weeks following last dose of study intervention.\n32. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF.\n33. Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before Week 0 (Day 1).\n34. Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.","70 Years",{"count":196,"type":22},245,[25],"The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment.\n\nPatients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment. The study will also employ a tapering protocol for a systematic approach to GC tapering, seeking to understand better the proportion of patients in remission who can successfully withdraw chronic GC completely.",[200],"Systemic Lupus Erythematosus",[202,203,204,205,206],"Lupus","Immunosuppressant","Glucocorticoid","Anifrolumab","Remission",{"date":41,"type":44},{"date":209,"type":44},"2026-04-13",{"date":211,"type":22},"2029-01-26",{"name":50,"class":51},104,{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":18,"minAge":222,"maxAge":89,"enrollmentInfo":223,"targetDuration":4,"studyType":225,"phases":4,"briefSummary":226,"conditions":227,"keywords":230,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100589242","tezspire-cardiac-events-pass-100589242","NCT06951867","Tezspire Cardiac Events PASS","An Observational Multi-Country Post-Authorisation Safety Study to Evaluate the Risk of Serious Adverse Cardiovascular Events in Adolescent and Adult Patients With Severe Asthma Taking Tezepelumab","TRESPASS","Inclusion Criteria:\n\n* patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period.\n\nExclusion Criteria for both exposed and unexposed groups include:\n\n* \\\u003C12 months of data availability prior to index date,\n* age \\\u003C12 years at index date,\n* history of congenital heart disease or heart transplant outcome-specific exclusion criterion applied for each objective will include the presence of non-fatal myocardial infarction or stroke and the specific outcome of interest in the 180 days prior to index date\n* for comparative analysis, an additional exclusion criterion will be considered, i.e. exposure to non-tezepelumab biologics on index date or within the 5-half-life clearance period of the biologic\n* matching criteria (including, among other variables, the type and duration of SOC exposure in the 12 months before index date and propensity score \\[PS\\] matching) will be applied to ensure exposed and unexposed patients' comparability","12 Years",{"count":224,"type":22},16640,"OBSERVATIONAL","The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for severe asthma.",[228,229],"Cardiovascular Events","MACE",[231,232,233,234,235,236,237,238,239],"post Marketing Requirements (PMR) study","cardiovascular events","non-fatal myocardial infarction","non-fatal stroke","cardiovascular death","arrythmias","coronary artery disease","heart failure","myocardial disorders",{"date":41,"type":44},{"date":242,"type":44},"2025-09-15",{"date":244,"type":22},"2029-05-31",{"name":50,"class":51},4,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},"100556952","phase-4-post-marketing-phase-4-safety--tolerability-study-of-breztri-aerospheretm-in-indian-patients-with-chronic-obstructive-pulmonary-disease-100556952","NCT06531798","Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease","Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg\u002F Glycopyrronium 7.2 mcg\u002F Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease","INDOS-B","Inclusion Criteria:\n\nPatients with a physician-confirmed diagnosis of COPD\n\n* With a history of one severe COPD exacerbation or two or more moderate COPD exacerbations in the preceding 12 months.\n* Post-bronchodilator FEV1 should be between ≥30 % to \\\u003C80% of the predicted normal.\n* Both male and female patients are allowed in the study\n* Female of Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal)\n* A urine pregnancy test must be negative at screening.\n* female participant must follow effective contraceptive method as outlined in protocol\n* Patients should be capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.\n* Chest x-ray within 6 months before screening must be acceptable to the investigator. Subjects who have a chest x-ray that reveals clinically significant abnormalities not believed to be due to the presence of COPD should not be included. A chest x-ray must be conducted if the most recent chest x-ray is not available at the time of screening.\n* Patients having moderate to severe exacerbations within 6 weeks before the Screening period.\n* Female patients who are pregnant or lactating or planning a family during the study period.\n* Patients with either a history of hypersensitivity to excipients of the study drug or drugs with a similar chemical structure or class to the study drug.\n* Patients participating in any current or future interventional trial during the study will not be enrolled in the current study.",{"count":256,"type":22},150,[258],"PHASE4","The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.",[261],"Moderate to Severe COPD",{"date":41,"type":44},{"date":264,"type":44},"2026-01-30",{"date":266,"type":22},"2027-12-30",{"name":50,"class":51},5,{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":225,"phases":4,"briefSummary":280,"conditions":281,"keywords":283,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100554088","nis-to-examine-the-effectiveness-of-tdc-in-patients-with-metastatic-non-squamous-nsclc-and-high-risk-genetic-alterations-100554088","NCT06494540","NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations","Prospective Non-interventional Study (NIS) to Examine the Effectiveness of Tremelimumab + Durvalumab + Platinum Chemotherapy (TDC) in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations","NAUTIC","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Decision to start first-line (1L) treatment with TDC according to the current SmPCs\n* Histologically or cytologically confirmed diagnosis of NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician)\n* No sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) alterations\n* Molecular Next Generation Sequencing (NGS) panel as per institutional standard has been initiated (including the following genes: KRAS, STK11, KEAP1, and TP53)\n* TTF-1 expression analysis has been initiated\n* PD-L1 expression analysis has been initiated\n* Women of childbearing potential must use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab\n* Ability to understand the study concept\n* Provision of signed informed consent form in accordance with applicable local provisions\n\nExclusion Criteria:\n\n* Current participation in interventional clinical trials\n* Contraindications according to current SmPCs\n* Any active tumor other than metastatic NSCLC\\*\n* Mixed histology NSCLC with both adenocarcinoma and squamous cell carcinoma components (adenosquamous carcinoma or any mixed NSQ- squamous tumor), regardless of the predominant component\n\n  * determined by investigator as likely to influence the prognosis or management of mNSCLC","120 Years",{"count":279,"type":22},600,"This prospective, multicenter, non-interventional study (NIS) in Germany aims to collect real-life data of patients with non-squamous (NSQ) metastatic non-small cell lung cancer (mNSCLC) (incl. large cell neuroendocrine carcinoma (LCNEC) if considered NSCLC-like by the treating physician) for whom 1st line treatment initiation with tremelimumab and durvalumab in combination with a platinum-based chemotherapy (TDC) according to marketing authorization was scheduled. The study aims to describe the effectiveness with respect to mutations in Kirsten rat sarcoma viral oncogene homolog (KRAS), Serine\u002Fthreonine kinase 11 (STK11), Kelch-like ECH-associated protein 1 (KEAP1), and Tumor protein p53 (TP53) as well as expression of Thyroid transcription factor 1 (TTF-1) and Programmed death-ligand 1 (PD-L1) in routine clinical practice. The generated data aims to deepen the understanding of optimal, biomarker-guided treatment strategies for NSQ mNSCLC in distinct subgroups with a high medical need.",[282],"Non-squamous Metastatic Non-Small-Cell Lung Carcinoma",[284,285,286,287,288,289,290,291,31],"NSCLC,","mNSCLC,","KRAS,","STK11,","KEAP1,","TP53,","POSEIDON,","Tremelimumab,",{"date":41,"type":44},{"date":294,"type":44},"2024-06-28",{"date":296,"type":22},"2029-12-31",{"name":50,"class":51},30,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":333},"100524065","phase-3-a-phase-iii-study-of-dato-dxd-with-or-without-durvalumab-compared-with-investigators-choice-of-chemotherapy-in-combination-with-pembrolizumab-in-patients-with-pd-l1-positive-locally-recurrent-inoperable-or-metastatic-triple-negative-breast-cancer-tropion-breast05-100524065","NCT06103864","A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)","A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)","Key Inclusion Criteria\n\n* Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines.\n* ECOG PS 0 or 1.\n* Participants are expected to provide an FFPE tumour sample collected from a locally recurrent inoperable or metastatic tumour. Alternatively, an archival FFPE tumour sample can be submitted; it must have been collected ≤ 3 years prior to the participant signing informed consent (screening start).\n* PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory.\n* No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.\n\n  \\- Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months have elapsed between completion of treatment with curative intent and the first documented recurrence.\n* Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin).\n* Measurable disease as per RECIST 1.1.\n* Adequate bone marrow reserve and organ function.\n* Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception.\n\nKey Exclusion Criteria\n\n* As judged by investigator, any evidence of diseases (such as severe or uncontrolled medical conditions including systemic diseases, uncontrolled hypertension, serious gastrointestinal conditions associated with diarrhoea, chronic diverticulitis or previous complicated diverticulitis, history of allogeneic organ transplant, and active bleeding diseases, ongoing and active infection, significant cardiac conditions, substance abuse, psychiatric illness\u002Fsocial situation or psychological conditions) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.\n* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before Cycle 1 Day 1 and of low potential risk for recurrence.\n* Participants with a history of previously treated neoplastic spinal cord compression or treated, clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.\n\n  \\- Participants with treated clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.\n* Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.\n* Active or uncontrolled hepatitis B or C virus infection.\n* Known HIV infection that is not well controlled.\n* Uncontrolled or significant cardiac disease.\n* History of non-infectious ILD\u002Fpneumonitis (including radiation pneumonitis) that required steroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* Clinically severe pulmonary function compromise.\n* Clinically significant corneal disease.\n* Active or prior documented autoimmune or inflammatory disorders.\n* Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy.\n* Any concurrent anti-cancer treatment.\n* Participants with a known severe hypersensitivity to PD-1\u002FPD-L1 inhibitors or Dato-DXd.\n* Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.",{"count":307,"type":22},625,[25],"This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.",[311],"Breast Cancer",[311,313,314,315,316,317,318,319,31,320,321,322,110,113,323,324,325,326],"Triple-negative","Metastatic","Inoperable","Datopotamab deruxtecan","Dato-DXd","DS1062a","DS1062","Paclitaxel","Nab-paclitaxel","Gemcitabine","PD-1\u002FPD-L1 Therapy","TROP2","Antibody Drug Conjugate (ADC)","Immune Checkpoint Inhibitor (ICI)",{"date":41,"type":44},{"date":329,"type":44},"2023-11-23",{"date":331,"type":22},"2030-09-30",{"name":50,"class":51},320,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":225,"phases":4,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":352},"100521319","osireal---osimertinib-rwe-on-egfrm-nsclc-in-spain-100521319","NCT06068049","OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain","An Ambispective, Non-interventional, Multiple Cohort Study to Assess the Management of Osimertinib Treatment in Patients With EGFRm Non-small Cell Lung Cancer Under Real-world Conditions in Spain","OSIREAL","Inclusion Criteria:\n\n* Female or male patients, treated with osimertinib\n* Age ≥ 18 years at starts of osimertinib treatment (i.e., index date).\n* Patients histologically diagnosed with EGFRm NSCLC (before index date):\n\n  * Patients with first-line treatment with EGFRm locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy (Cohort 1).\n  * Patients with stage IB-IIIA whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, after complete tumor resection (Cohort 2).\n  * Patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, that received osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment (Cohort 3).\n  * Patients with locally advanced, unresectable NSCLC treated with osimertinib, whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (cohort 4).\n* Provision of informed consent (for alive patients). Deceased patients who met the selection criteria when they started treatment with osimertinib could also be included in the study.\n\nExclusion Criteria:\n\n* Osimertinib treatment administration in a clinical trial setting.",{"count":343,"type":22},500,"Lung cancer (LC) is the tumor responsible for the highest mortality worldwide. Lung adenocarcinoma is the major subtype of lung cancer and represents the deadliest human cancer, affecting current-, ex-, and even non-smokers.\n\nOsimertinib is indicated as monotherapy for the first-line (1L) treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations in the EGFR, for the treatment of adult patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC, for the adjuvant treatment of adult patients with NSCLC stages IB-IIIA after complete resection of the tumor that has activating mutations of the EGFR, for the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutation and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy for the 1L treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations.\n\nThe FLAURA trial showed that treatment with osimertinib significantly prolongs PFS and improves overall survival (OS) compared to standard EGFR tyrosine kinase inhibitors.\n\nThe results of the ADAURA study showed a reduction in the risk of recurrence or death by 83% in stages II to IIIA, and in 80% in stages IB-IIIA. Additionally, osimertinib demonstrated a highly statistically significant improvement in DFS and HRQoL was maintained.\n\nThe FLAURA2 trial showed that 1L treatment with osimertinib-chemotherapy led to significantly longer progression-free survival than osimertinib monotherapy among patients with EGFR mutated (EGFRm) advanced NSCLC.\n\nThe LAURA trial showed that treatment with osimertinib after chemoradiotherapy resulted in significantly longer PFS than placebo among patients with unresectable stage III EGFRm NSCLC.\n\nTo date, there are no real-world data on osimertinib either in 1L treatment in locally advanced or metastatic EGFRm NSCLC nor as adjuvant treatment, in early stages of cancer, regarding effectiveness, adherence, treatment exposure and quality of life (QoL), among others, and in particular for the use of osimertinib in subpopulations less represented in pivotal trials such as elderly or patients with uncommon EGFR mutations. Furthermore, the duration of treatment in real life in Spain is also a gap, as it appears to be longer than in clinical trials, which means that there are patients who are treated beyond progression.\n\nTherefore, this observational ambispective study based on real-world data aims to provide data on osimertinib use as adjuvant treatment in adult patients diagnosed with stages IB-IIIA EGFRm NSCLC, in 1L treatment in patients with locally advanced or metastatic EGFRm NSCLC, as consolidation treatment in patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy in patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution. Specifically, the study will focus on patient characteristics, adherence, treatment exposure, administration, survival, quality of life, effectiveness and safety providing insights into osimertinib use in daily practice for patients with EGFRm NSCLC, where there are current evidence gaps.",[135],{"date":41,"type":44},{"date":348,"type":44},"2023-07-28",{"date":350,"type":22},"2029-06-15",{"name":50,"class":51},26,{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":374},"100652431","phase-2-a-study-of-azd0292-in-chinese-participants-with-bronchiectasis-and-chronic-pseudomonas-aeruginosa-colonization-100652431","NCT07774403","A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","A Phase II Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","BREEZE","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age at the time of signing the informed consent\u002Fassent.\n* Weight ≥ 35 kg.\n* Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.\n* Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics\n* Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization\n* Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.\n* Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening\n* Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.\n* Capable of giving signed informed consent\u002Fassent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n\nExclusion Criteria:\n\n* Primary lung diagnosis other than bronchiectasis\n* Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy\n* Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment\n* Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed\n* Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment\n* AIDS or Advanced human immunodeficiency virus disease (CD4 count of \\\u003C 200 cells\u002Fmm3)\n* History of severe adverse reaction associated with a mAb, and\u002For history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine\u002Fadrenaline or hospitalization), and\u002For history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration\n* Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening\n* Chronic immunosuppressive therapy (including prednisolone \\> 5 mg or equivalent) newly initiated within the last 3 months\n* Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study\n* Participation with a study intervention used within the last 30 days or 5 half-lives of the investigational product from the other clinical study, whichever is longer, prior to screening.\n* Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration",{"count":362,"type":22},84,[94],"AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.",[366],"Bronchiectasis With Pseudomonas Aeruginosa Colonization","2026-08-18",{"date":178,"type":44},{"date":370,"type":44},"2026-06-24",{"date":372,"type":22},"2028-06-06",{"name":50,"class":51},40,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":18,"minAge":383,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":392,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},"100627125","phase-3-roll-over-study-for-participants-who-have-completed-a-previous-clinical-study-with-benralizumab-fasenra-and-benefit-from-continued-treatment-100627125","NCT07444567","Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment","ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study With Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit From Continued Treatment","ROSY-F","Inclusion Criteria:\n\n* 1\\. Provision of signed and dated written ICF.\n\n  2\\. Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment.\n* 3\\. Participants must agree to follow the contraception requirements as per their respective parent protocols from study inclusion up to 12 weeks after the last dose of study treatment.\n* 4\\. Participants without childbearing potential at enrolment must agree to start appropriate contraception if childbearing potential develops during the study and up to 12 weeks after the last dose of study treatment.\n* 5\\. Participants who are unable to access commercially available benralizumab and clinically indicated for continuation.\n\nExclusion Criteria:\n\n* 1\\. Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting benralizumab.\n* 2\\. Participants who are planning to use live\u002Flive-attenuated vaccines.\n* 3\\. Participants who are planning to use biologic therapies, including B-cell therapies with the exception for the treatment of co-morbidities where no alternative medicine is available.\n* 4\\. Participants with any medical condition (such as cancer or viral infections \\[hepatitis\\]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments.\n* 5\\. Concurrently enrolled in any clinical study (other than a parent study).\n* 6\\. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period.\n* 7\\. Local access to commercially available benralizumab.","6 Years",{"count":385,"type":22},230,[25],"The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term safety and tolerability of benralizumab.",[389,390,391],"Asthma","Eosinophilic Granulomatosis With Polyangiitis (EGPA)","Hypereosinophilic Syndrome (HES)",[389,393,391],"Eosinophilic Granulomatosis with Polyangiitis (EGPA)",{"date":178,"type":44},{"date":396,"type":44},"2026-07-24",{"date":398,"type":22},"2030-01-03",{"name":50,"class":51},45,{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":23,"phases":410,"briefSummary":405,"conditions":411,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":426},"100601788","phase-1-a-study-to-investigate-safety-of-azd6750-in-adult-participants-with-select-advanced-or-metastatic-solid-tumors-100601788","NCT07115043","A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors","A Phase I\u002FII Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors","Inclusion criteria:\n\n* Participant ≥ 18 year\n* ECOG PS of 0 to 1\n* Provision of 'archival' tumor specimen\n* At least one measurable lesion according to RECIST v1.1,\n* Minimum life expectancy of 12 weeks\n* Adequate and stable cardiac function\n* Adequate bone marrow, liver and kidney function\n* Body weight ≥ 35 kg\n* Capable of giving signed informed consent\n\nModule 1 specific inclusion criteria:\n\n• Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer\u002Fgastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC\n\nModule 2 specific inclusion criteria:\n\n* Participants with Stage IV NSCLC Dose Escalation\u002FBackfills\n\n  1. Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR\n  2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Dose Expansion\n\n  \u003C!-- -->\n\n  1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Exclusion criteria:\n* Any evidence of:\n\nSevere or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions\n\n* History or planned organ or allogeneic stem cell transplantation.\n* Active or prior documented autoimmune or inflammatory disorders, within the past 3 years\n* Any prior toxicities that led to permanent discontinuation of prior immunotherapy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids\n* Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.\n* Active uncontrolled or chronic infection of hepatitis B, hepatitis C\n* Prior history of Grade ≥ 3 non-infectious pneumonitis.\n* Participant requires chronic immunosuppressive therapy (including steroids \\> 10 mg prednisone\u002Fday or equivalent).\n* Receipt of live attenuated vaccine within 30 days.\n\nModule 2 specific exclusion criteria:\n\n* Previous treatment with anti-TIGIT therapy\n* 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC",{"count":409,"type":22},120,[93,94],[412,135,413,414,415,416,417,418,419],"Melanoma","Squamous Cell Carcinoma (Skin)","Renal Cell Carcinoma","Merkel Cell Carcinoma","Triple Negative Breast Cancer","Head and Neck Squamous Cell Carcinoma","Gastric Cancer\u002FGastroesophageal Junction Cancer","High Grade Serous Ovarian Carcinoma",{"date":178,"type":44},{"date":422,"type":44},"2025-07-29",{"date":424,"type":22},"2029-10-02",{"name":50,"class":51},13,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":435,"minAge":19,"maxAge":89,"enrollmentInfo":436,"targetDuration":4,"studyType":225,"phases":4,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":447},"100596759","anifrolumab-pregnancy-study-100596759","NCT07049653","Anifrolumab Pregnancy Study","A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab","ROSE","Inclusion criteria for EXPOSED SOURCE POPULATION:\n\n* Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2\n* Women diagnosed with SLE before pregnancy\n* Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and\u002For 16-week period prior to LMP2\n\nExclusion criteria for EXPOSED SOURCE POPULATION:\n\n\\- Pregnancies whose date of conception cannot be established\n\nInclusion criteria for UNEXPOSED SOURCE POPULATION:\n\n* Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2\n* Women diagnosed with SLE before pregnancy\n* Women treated with SLE SOC during pregnancy\n\nExclusion criteria for UNEXPOSED SOURCE POPULATION:\n\n* Women treated with anifrolumab during pregnancy and\u002For 16-week period prior to LMP2\n* Pregnancies whose date of conception cannot be established\n\nInclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:\n\n\\- Women with moderate\u002Fsevere SLE\n\nExclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:\n\n* Women with a history of CM or chromosomal abnormalities (according to available records), before delivery\n* Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy","FEMALE",{"count":343,"type":22},"This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.",[200],[440],"pregnancy, anifrolumab, SLE",{"date":178,"type":44},{"date":443,"type":44},"2026-06-04",{"date":445,"type":22},"2030-12-10",{"name":50,"class":51},1,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":89,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":461,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":469},"100558321","phase-3-a-study-of-surovatamig-azd0486-plus-rituximab-in-previously-untreated-follicular-lymphoma-patients-100558321","NCT06549595","A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients","A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.\n2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification\n3. ECOG performance status of 0 to 2\n4. No prior systemic lymphoma-directed therapy\n5. Need for systemic treatment meeting at least 1 GELF criteria\n6. FDG-avid and measurable disease\n7. Stage II to IV and FLIPI 2-5 \\[Phase III only\\]\n8. Adequate liver, hematological, renal and cardiac function.\n\nThe above is a summary, other inclusion criteria details may apply\n\nExclusion Criteria:\n\n1. Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade\u002Faggressive lymphoma\n2. Contra-indication to BR, RCVP, and R-CHOP\n3. Participants with or history of CNS lymphoma\n4. History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety\n5. Presence of \\>5000 circulating lymphoma cells\n6. Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he\u002Fshe were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment\n7. Known history of hemophagocytic lymphohistiocytosis\u002Fmacrophage activation syndrome (HLH\u002FMAS)\n\nThe above is a summary, other exclusion criteria details may apply",{"count":456,"type":22},1018,[25],"This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.",[460],"Untreated Follicular Lymphoma",[462],"Follicular Lymphoma",{"date":178,"type":44},{"date":465,"type":44},"2024-08-07",{"date":467,"type":22},"2031-11-26",{"name":50,"class":51},228,{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":481,"briefSummary":482,"conditions":483,"keywords":484,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":495},"100551997","phase-3-phase-3-study-of-t-dxd-and-rilvegostomig-versus-soc-in-advanced-her2-expressing-biliary-tract-cancer-100551997","NCT06467357","Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer","DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer","DESTINY-BTC01","Key Inclusion Criteria:\n\n* Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations.\n* Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and\u002For adjuvant setting is permissible provided there is \\> 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.\n* Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.\n* Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives.\n* Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (Randomized portion only)\n* WHO\u002FECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n* Adequate organ and bone marrow function within 14 days before randomization.\n* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.\n* Minimum life expectancy of 12 weeks.\n\nKey Exclusion Criteria:\n\n* Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines.\n* Histologically confirmed ampullary carcinoma.\n* Any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the Investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results.\n* Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n* Medical history of myocardial infarction within 6 months before randomization\u002Fenrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (\\\u003C 6 months) cardiovascular event including stroke.\n* Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.\n* Active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\> 450 msec (males) based on average of the screening triplicate 12-lead ECG.\n* History of (non-infectious) ILD\u002Fpneumonitis, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion etc).\n* Prior pneumonectomy (complete).\n* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. Patients with prior cholangitis\u002Fbiliary tract infections\u002Fbiliary intervention (eg, stent, external drain) should have completed a full course of antibiotics prior to randomization.\n* Active primary immunodeficiency, known uncontrolled active HIV infection or HCV.\n* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected nonmelanoma skin cancer and curatively treated in situ disease. For certain participant populations, exceptions could also include carcinomas in-situ or Ta tumors treated with curative intent.\n* Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (Drainage and Cell free and Concentrated Ascites Reinfusion Therapy are not allowed within 2 weeks prior to screening assessment).\n* Any concurrent anticancer treatment without an adequate washout period prior to randomization. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is allowed.\n* History of organ transplants or allogenic stem cell transplant.","99 Years",{"count":480,"type":22},620,[25],"The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.",[28],[28,485,486,487,488,30],"HER2","HER2 expressing BTC","Trastuzumab deruxtecan","T-DXd",{"date":178,"type":44},{"date":491,"type":44},"2024-08-12",{"date":493,"type":22},"2029-05-16",{"name":50,"class":51},269,{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":89,"enrollmentInfo":504,"targetDuration":4,"studyType":225,"phases":4,"briefSummary":506,"conditions":507,"keywords":514,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":542},"100551878","non-interventional-study-of-patients-with-transthyretin-attr-amyloidosis-100551878","NCT06465810","Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis","A Non-interventional, Prospective, Multi-country Study Collecting Real-world Data on the Characteristics, Treatment Patterns, and Outcomes of Patients With Transthyretin (ATTR) Amyloidosis","MaesTTRo","Inclusion Criteria:\n\n* Patient willing and able to provide written informed consent to participate in the study\n* Confirmed diagnosis of amyloid transthyretin (ATTR) amyloidosis\n* Aged ≥18 years at the time of signing the informed consent\n* Patient willing and able to participate in collection of electronic patient reported outcomes (PROs)\n\nExclusion Criteria:\n\n* Concurrent participation in any interventional trial for ATTR amyloidosis\n* Involvement in the planning and\u002For conduct of the current study\n* Patients with evidence of primary or light chain amyloidosis (AL) or serum protein A amyloidosis (AA)\n* Asymptomatic patients with ATTR amyloidosis and asymptomatic ATTR mutation carriers",{"count":505,"type":22},1850,"The MaesTTRo study aims to enroll a global cohort of patients with transthyretin (ATTR) amyloidosis to longitudinally observe the natural course of the disease and describe real-world treatment patterns and outcomes. In addition, information on the effectiveness of ATTR amyloidosis treatments, including eplontersen, which is a ligand-conjugated antisense oligonucleotide gene silencing treatment targeting activity against both the mutant and wild-type TTR protein, will be collected.",[508,509,510,511,512,513],"Transthyretin Amyloidosis","ATTR-CM","ATTRv-PN","ATTR","ATTR-Mixed","hATTR",[515,516,517,518,519,520,521,522,523,524,525,511,526,527,528,529,530,531,532,533,534,535],"Amyloidosis","Transthyretin","Hereditary transthyretin-mediated (hATTR) amyloidosis","hATTR amyloidosis","Hereditary ATTR amyloidosis","Wild-type amyloidosis","wtATTR amyloidosis","ATTRv amyloidosis","ATTRwt amyloidosis","Polyneuropathy","Familial amyloid polyneuropathies","Transthyretin amyloidosis","TTR-mediated amyloidosis","Polyneuropathies","Amyloid neuropathies","Amyloid neuropathies, familial","Amyloidosis, familial","Eplontersen","Non-interventional","Observational","Real-world",{"date":178,"type":44},{"date":538,"type":44},"2024-06-25",{"date":540,"type":22},"2031-12-29",{"name":50,"class":51},89,{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":18,"minAge":222,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":557,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":569},"100526620","phase-1-azd0486-as-monotherapy-in-b-cell-acute-lymphoblastic-leukaemia-100526620","NCT06137118","AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia","A Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia","SYRUS","Inclusion Criteria:\n\n* Age: 12 years and above (Parts A, B, C and D).\n* Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with:\n\n  1. Bone marrow infiltration with \\>\u002F= 5% blasts\n  2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option (Parts A, B, C); or relapsed or refractory to ≥1 prior line of therapy (Part D).\n  3. Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs.\n* For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. For Participants 16 years or younger, Lansky score more or equal to 50%.\n\nThe above is a summary, other inclusion criteria details may apply.\n\nExclusion Criteria:\n\n* Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria), or signs of CNS involvement.\n* Isolated extramedullary disease relapse.\n* Testicular leukemia\n* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy.\n* History of other malignancy (with certain exceptions).\n* Unresolved AEs \\>\u002F= Grade 2, from prior therapies\n* Prior therapy with ADCs within 3 weeks, TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy.\n* GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment.\n\nThe above is a summary, other exclusion criteria details may apply.",{"count":552,"type":22},255,[93,94],"This is a Phase 1\u002F2, global multicentre, open-label, single-arm, dose escalation and dose optimization study of surovatamig (AZD0486) to evaluate the safety, tolerability, and efficacy of surovatamig (AZD0486) monotherapy in participants with R\u002FR B ALL. The study will consist of 4 parts. Part A: monotherapy dose escalation in 3L+ B-ALL. Part B: dose optimization in 3L+ B-ALL. Part C: Dose expansion in 3L+ B-ALL. Part D: Dose optimization and efficacy expansion in R\u002FR B-ALL (2L+)",[556],"B-cell Acute Lymphoblastic Leukemia (B-ALL)",[558,559,560,561,562],"B-cell acute lymphoblastic leukemia","Leukemia","B-lymphocytes","Surovatamig","AZD0486",{"date":178,"type":44},{"date":565,"type":44},"2023-12-29",{"date":567,"type":22},"2028-09-15",{"name":50,"class":51},82,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":594},"100524301","phase-1-azd0305-as-monotherapy-or-in-combination-with-anticancer-agents-in-participants-with-multiple-myeloma-100524301","NCT06106945","AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma","A Modular Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Multiple Myeloma","Key Inclusion Criteria:\n\n* Participants must be at least 18 years of age or the legal age of consent in the jurisdiction\n* in which the study is taking place;\n* Eastern Cooperative Oncology Group performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3;\n* Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria;\n* Participants must have one or more measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;\n* Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module;\n* Participants must have received at least 3 prior lines of treatment in module 1, or 1-3 prior lines in modules 2 and 3, with additional module-specific requirements related to prior lines of therapy\n\nThe above is a summary of key criteria, other inclusion criteria details may apply\n\nKey Exclusion Criteria:\n\n* Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);\n* Participants exhibiting clinical signs of central nervous system involvement of MM;\n* Participants with known COPD, or previous history of ILD\u002Fpneumonitis;\n* Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification;\n* Participants who have severe cardiovascular disease which is not adequately controlled;\n* Participants who have a history of immunodeficiency disease;\n* Participants with peripheral neuropathy ≥ Grade 2;\n* Primary refractory MM;\n* Participants who have previously received anti-GPRC5D or MMAE-containing treatment;\n* Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention;\n* Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply;\n* Participants with previous history of active JC virus infection resulting in PML;\n* Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monoclonal antibody therapy;\n* Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and\u002For other administration\n\nThe above is a summary of key criteria, other exclusion criteria details may apply",{"count":578,"type":22},226,[93,94],"This is a Phase I\u002FII, modular, open-label, multicenter, dose escalation, and dose expansion\u002Foptimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics and efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.",[582],"Multiple Myeloma",[584,102,585,582,586,587],"GPRC5D","AZD0305","MM","MMAE",{"date":178,"type":44},{"date":590,"type":44},"2023-12-05",{"date":592,"type":22},"2027-08-16",{"name":50,"class":51},43,{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":89,"enrollmentInfo":603,"targetDuration":4,"studyType":23,"phases":605,"briefSummary":606,"conditions":607,"keywords":609,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":619},"100498799","phase-3-a-study-of-camizestrant-in-erher2--early-breast-cancer-after-at-least-2-years-of-standard-adjuvant-endocrine-therapy-100498799","NCT05774951","A Study of Camizestrant in ER+\u002FHER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy","CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+\u002FHER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence","CAMBRIA-1","Inclusion Criteria:\n\n* Women and Men, ≥18 years at the time of screening (or per national guidelines)\n* Histologically confirmed ER+\u002FHER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.\n* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy\n* Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+\u002F- CDK4\u002F6 inhibitor)\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n* Adequate organ and marrow function\n\nExclusion criteria:\n\n* Inoperable locally advanced or metastatic breast cancer\n* Pathological complete response following treatment with neoadjuvant therapy\n* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation\n* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance\n* Known LVEF \\\u003C50% with heart failure NYHA Grade ≥2.\n* Mean resting QTcF interval \\>480 ms at screening\n* Concurrent exogenous sex hormone therapy\n* Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)\n* Previous treatment with camizestrant, investigational SERDs\u002Finvestigational ER targeting agents, or fulvestrant\n* Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding\n* Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-\u002Fperi-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist",{"count":604,"type":22},4300,[25],"This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+\u002FHER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.",[608],"Breast Cancer, Early Breast Cancer",[610,611,612],"ER+","HER2-","breast cancer",{"date":178,"type":44},{"date":615,"type":44},"2023-03-31",{"date":617,"type":22},"2036-05-29",{"name":50,"class":51},709,{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":23,"phases":630,"briefSummary":631,"conditions":632,"keywords":635,"overallStatus":643,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":651},"100652683","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-elecoglipron-in-asian-participants-with-obesity-or-overweight-with-or-without-type-2-diabetes-mellitus-100652683","NCT07775404","A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus","A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (EMBOLD-Asia)","Elecoglipron","Inclusion Criteria:\n\n* Adult participant aged 18 years or older at the time of informed consent.\n* Body mass index (BMI) at screening of:\n* 28 kg\u002Fm\\^2 or higher, or\n* 24 kg\u002Fm\\^2 to less than 28 kg\u002Fm\\^2 with at least 1 weight-related comorbidity.\n* Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)\n* History of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n* Participants with type 2 diabetes mellitus, if enrolled, and have HbA1c from 6.5% to less than 10.0% at screening.\n\nExclusion Criteria:\n\n* Any of the following medical history, laboratory values, or complications related to diabetes:\n* T1DM\n* HbA1c ≥ 10% (86 mmol\u002Fmol) at the screening visit\n* Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and\u002For macular edema.\n* Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.\n* History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis.\n* History\u002Ffamily history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2.",{"count":629,"type":22},351,[25],"The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.",[633,634],"Obesity","Overweight",[636,637,638,639,640,641,642],"elecoglipron","AZD5004","ECC5004","GLP-1 receptor agonist","Weight loss","Weight management","Type 2 diabetes mellitus","NOT_YET_RECRUITING","2026-08-17",{"date":41,"type":44},{"date":647,"type":22},"2026-08-28",{"date":649,"type":22},"2028-04-20",{"name":50,"class":51},49,{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":660,"targetDuration":4,"studyType":23,"phases":661,"briefSummary":662,"conditions":663,"keywords":667,"overallStatus":643,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":670,"startDateStruct":671,"completionDateStruct":672,"leadSponsor":674,"locationsCount":675},"100652565","phase-3-a-study-to-evaluate-effect-of-azd6234-as-an-adjunct-to-incretin-based-therapies-in-adult-participants-with-obesity-or-overweight-with-weight-related-comorbidity-with-or-without-type-2-diabetes-mellitus-100652565","NCT07776509","A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus","A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 as an Adjunct to Incretin-based Therapies in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE 3)","SELENE 3","Inclusion Criteria:\n\n* Males \\& females (inclusive of all gender identities) age ≥18 years\n* BMI ≥ 30 kg\u002Fm2 OR BMI ≥ 27 kg\u002Fm2 with at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence\n* For participants with T2DM only:\n\n  * Diagnosed with T2DM ≥ 90 days prior to Screening\n  * HbA1c value at Screening of ≥6.0% (42 mmol\u002Fmol) and ≤9.0% (75 mmol\u002Fmol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and\u002For incretin-based medication\n* Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation.\n* Stable body weight (≤ 3% body weight change) for at least 3 months prior to Randomisation\n* History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime\n\nExclusion Criteria:\n\n* Obesity primarily caused by other endocrine disorders\n* Type 1 diabetes mellitus\n* Significant hepatobiliary disease and\u002For any of the following results at Screening:\n\n  * ALT ≥ 3.0 × ULN\n  * AST ≥ 3.0 × ULN\n  * TBL \\> 1.5 × ULN (except for cases of known Gilbert's Syndrome)\n* Use of insulin therapy for T2DM within 3 months prior to screening",{"count":343,"type":22},[25],"The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment.",[664,665,666],"Obesity or Overweight","Weight-Related Comorbidity","With\u002FWithout Diabetes Mellitus, Type 2",[633,634,668,669],"AZD6234","Diabetes Mellitus, Type 2",{"date":41,"type":44},{"date":43,"type":22},{"date":673,"type":22},"2028-08-09",{"name":50,"class":51},88,{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":4,"eligibilityCriteria":682,"healthyVolunteers":161,"sex":18,"minAge":19,"maxAge":162,"enrollmentInfo":683,"targetDuration":4,"studyType":23,"phases":685,"briefSummary":686,"conditions":687,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":689,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":694,"locationsCount":447},"100637565","phase-1-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-azd7760-in-healthy-japanese-adults-100637565","NCT07612813","A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults","A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants","Inclusion Criteria:\n\n* Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg\u002Fm2 (inclusive) at screening.\n* Healthy Japanese participants with no clinically significant concomitant diseases or medications.\n\nExclusion Criteria:\n\n* Known hypersensitivity to any component of the study intervention.\n* Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.\n* Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.\n* AST or ALT above 1.5 × ULN at screening.\n* Estimated glomerular filtration rate \\\u003C 90 mL\u002Fmin\u002F1.73 m2.\n* Hemoglobin or platelet count below the lower limit of normal at screening.\n* White blood cell counts outside normal reference ranges.\n* History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.\n* Any clinically significant abnormalities on 12-lead ECG at screening,\n* Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.\n* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.\n* Any condition that has the potential to increase clearance of the study intervention.\n* Blood donation or collection as follows:\n\n  1. 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.\n  2. 200 mL whole blood donation within 4 weeks prior to study drug administration.\n  3. Apheresis donation within 2 weeks prior to study drug administration.\n* Absence of suitable veins for blood sampling and administration of study intervention.\n* Any other condition that would compromise the safety of the participants.\n* Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.\n* Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.",{"count":684,"type":22},18,[93],"The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.",[688],"Staphylococcus Aureus Bloodstream Infection",{"date":367,"type":44},{"date":691,"type":44},"2026-06-29",{"date":693,"type":22},"2027-09-13",{"name":50,"class":51},{"id":696,"slug":697,"hasResults":12,"nctId":698,"briefTitle":699,"officialTitle":700,"acronym":701,"eligibilityCriteria":702,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":703,"targetDuration":4,"studyType":225,"phases":4,"briefSummary":705,"conditions":706,"keywords":708,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":711,"startDateStruct":712,"completionDateStruct":713,"leadSponsor":715,"locationsCount":716},"100623676","ravulizumab-outcomes-in-polish-patients-with-ahus-100623676","NCT07399730","Ravulizumab Outcomes in Polish Patients With aHUS","A Non-interventional Study Evaluating Ravulizumab Treatment Outcomes in Polish Patients With Atypical Hemolytic Uremic Syndrome","aHUS-OPTIMUM","Inclusion Criteria:\n\n* Patients of all ages diagnosed with atypical hemolytic uremic syndrome (aHUS) who received treatment with ravulizumab under the National Drug Program (NDP) in Poland.\n* Patients who are willing to participate in the study and have provided informed consent by signing the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Individuals who intend to participate in a clinical trial for atypical hemolytic uremic syndrome (aHUS) on or after the date of their first ravulizumab infusion through the National Drug Program.\n* Patients with cognitive impairments, those who are unwilling to participate, or those facing language barriers that hinder adequate comprehension or cooperation.",{"count":704,"type":22},80,"This multicenter, observational cohort study uses retrospective collection of past medical history and prospective follow-up to capture longitudinal data on the management and clinical outcomes of patients with atypical hemolytic uremic syndrome (aHUS) treated with ravulizumab as part of routine clinical practice under Poland's National Drug Program (NDP).",[707],"Atypical Hemolytic Uremic Syndrome",[709,707,710,534],"aHUS","Ravulizumab",{"date":367,"type":44},{"date":370,"type":44},{"date":714,"type":22},"2029-09-30",{"name":50,"class":51},10,""]