[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nuvation Bio Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":180},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,73,97,128,158],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645478","phase-2-safety-and-efficacy-study-of-safusidenib-in-participants-with-idh1-mutant-glioma-who-discontinued-vorasidenib-treatment-due-to-progressive-disease-100645478",false,"NCT07703436","Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease","A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease","Key Inclusion Criteria:\n\n* Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria\n* IDH1 mutation (e.g., R132H\u002FC\u002FG\u002FS\u002FL) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS).\n* Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection).\n* Measurable disease per modified RANO 2.0 confirmed by BICR during Screening.\n* Previously treated with vorasidenib and experienced radiographic disease progression during treatment and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. Disease progression must be confirmed by BICR using modified RANO 2.0.\n* Adequate hematologic and organ function\n* Expected survival of ≥12 months\n\nKey Exclusion Criteria:\n\n* Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma.\n* Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression\n* Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma.\n* Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.\n* Significant functional or neurocognitive deficits, including uncontrolled seizures\n* Evidence of leptomeningeal disease.\n* Use of therapeutic doses of steroids for signs\u002Fsymptoms of glioma. Participants taking physiologic doses (defined as equivalent of \\\u003C1.5 mg of dexamethasone equivalent) for medical conditions not related to glioma will be permitted.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review \\[BICR\\] per modified Response Assessment in Neuro-Oncology \\[RANO\\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.",[26,27,28,29,30,31,32,33],"Grade 2 IDH1-mutant Glioma","Grade 3 IDH1-mutant Glioma","Glioma","IDH1-mutant Glioma","Oligodendroglioma","Oligodendroglioma IDH-1 Mutant and 1\u002Fp19q-codeleted","Astrocytoma IDH Mutant Grade 3","Astrocytoma IDH Mutant Grade 2","NOT_YET_RECRUITING","2026-08-10",{"date":37,"type":38},"2026-08-11","ACTUAL",{"date":40,"type":20},"2027-03",{"date":42,"type":20},"2032-03",{"name":44,"class":45},"Nuvation Bio Inc.","INDUSTRY",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100649923","phase-1-study-on-the-effect-of-famotidine-on-pharmacokinetics-of-taletrectinib-100649923","NCT07742384","Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib","An Open-label, Fixed Sequence Study to Evaluate the Effect of Famotidine on the Pharmacokinetics and Safety of Taletrectinib in Healthy Adult Participant","Inclusion Criteria:\n\n1. The participant must voluntarily sign an Informed Consent Form (ICF) prior to any study-related procedures.\n2. Participants are able to communicate well with Investigators and complete the study in accordance with the protocol.\n3. Between the ages of 18 and 55 years (inclusive) at the time of signing the ICF.\n4. Healthy adult participants (healthy refers to the status of no clinically relevant abnormalities identified through medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory examinations).\n5. Body weight is greater than 50.0 kg at Screening and the body mass index (BMI) is between 19 and 26 kg\u002Fm2.\n6. Males and\u002For females who meet any of the following criteria:\n\n   1. For males (irrespective of surgical sterilization \\[vasectomy\\]): agree to use effective contraception methods during the study intervention period and for at least 90 days after the last dose of study drug or agree with complete abstinence; and agree not to donate sperm during this same time period.\n   2. Females without menses for at least 1 year prior to Screening or documented to be surgically sterilized. Females of childbearing potential (FOCBP) must agree to use 2 concurrent highly effective methods of contraception or agree with complete abstinence from sexual intercourse from signing of the ICF until 45 days after the last dose of study drug. Usage of hormonotherapy for contraception should be recorded as well.\n7. For all females of childbearing potential, a negative pregnancy test must be obtained within 1 day before the first dose of study drug. Female participants of non-childbearing potential must meet at least 1 of the following criteria:\n\n   * Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n   * Have undergone a documented hysterectomy and\u002For bilateral oophorectomy.\n   * Have medically confirmed ovarian failure. All other female participants (including female participants with tubal ligations) are considered to be of childbearing potential.\n8. Must agree to avoid strenuous exercise from 72 hours prior to dosing on Day 1 of Period 1 until the EOT\u002FET visit.\n9. Able to sign the informed consent and to comply with the protocol.\n10. Patients with adequate organ function meeting the following criteria:\n\n    1. Serum total bilirubin: ≤1×ULN.\n    2. Estimated creatinine clearance (CLcr) ≥90 mL\u002Fmin as calculated using the methodstandard for the institution (e.g., Cockcroft-Gault Equation).\n\nExclusion Criteria:\n\n1. Evidence or history of clinically significant hematology, kidney, endocrine, lung, gastrointestinal, cardiovascular, liver, mental, neurological, or allergic diseases (including drug allergies, but not including untreated, asymptomatic seasonal allergies at the time of dosing).\n2. According to the Investigator's judgment, there are clinically significant abnormal laboratory results (hematology, serum chemistry, coagulation, and urinalysis).\n3. Any active or unstable medical condition as judged by the Investigator.\n4. The Investigator believes that the participant may be at increased risk of eye disease or have a history of eye disease, such as glaucoma, retinal shedding, glass turbidity, moth disease,etc.\n5. Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality including but not limited to any of the following at Screening and Admission,repeat testing is allowed for verification, at the discretion of the Investigator:\n\n   1. Heart rate \\\u003C50 beats per minute (bpm) or \\>100 bpm (taken during supine blood pressure measurement).\n   2. Systolic blood pressure \\\u003C90 mmHg or ≥140 mmHg; diastolic blood pressure \\\u003C50 mmHg or ≥90 mmHg (supine blood pressure measurement).\n6. The 12-lead ECG shows that the QTc is \\>450 milliseconds (msec) or the QRS duration exceeds \\>120 msec. If the QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc and QRS values should be used to determine the participant's eligibility.\n7. History of febrile illness within 5 days prior to the first dose of study drug.\n8. Positive blood screen for human Hepatitis B virus surface antigen, hepati is C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) antibody.\n9. Pregnancy or lactation\u002Fbreastfeeding.\n10. Use of food or drugs that are known to be strong or moderate cytochrome P450 (CYP)3A4\u002F5 inhibitors or inducers or to be P-glycoprotein inhibitors within 14 days prior to the first dose of study drug until the EOT\u002FET visit.\n11. Consumption of Seville oranges or grapefruit-containing foods or beverages within 14 days prior to the first dose of study until the EOT\u002FET visit.\n12. Participants who have used prescription or over-the-counter (OTC) medication (other than ≤2 g\u002Fday acetaminophen or ≤800 mg\u002Fday ibuprofen or allowed contraception methods), vitamins, or herbal remedies, within 2 weeks or 5 half-lives before study drug administration, whichever is longer.\n13. Participants who have received live vaccines or attenuated vaccines within 28 days prior to the first dose of study drug until the EOT\u002FET visit.\n14. Participants who have received any investigational drug, device, biologic, or other agent (within 60 days or 5 half-lives, whichever is longer) prior to study drug administration on Day 1.\n15. Participants who are reluctant to stop consuming caffeinated or purine-containing foods (e.g., coffee, tea, cola, chocolate) from 72 hours prior to the first dose of study drug until the EOT\u002FET visit.\n16. History of regular alcohol consumption exceeding 14 drinks\u002Fweek (1 drink =12 ounces \\[360 mL\\] beer, or 5 ounces \\[150 mL\\] of wine, or 1.5 ounces \\[45 mL\\] of hard liquor), or participants who are unwilling to stop drinking alcohol from 72 hours prior to the first dose of study drug until the EOT\u002FET visit.\n17. Use of tobacco- or nicotine-containing products ≥5 cigarettes per day, or participants who are unwilling\u002Funable to stop tobacco- or nicotine-containing products from 72 hours prior to the first dose of study drug to the EOT\u002FET visit.\n18. A positive urine drug screen.\n19. A positive blood or breath test for alcohol.\n20. Underwent major surgery within 6 months prior to the first dose of study drug.\n21. Blood donation or blood loss within 3 months prior to the first dose of study drug of ≥400 mL.\n22. Plasma donation within 30 days prior to the first dose of study drug.\n23. Participants with gastrointestinal, liver, kidney disease, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion within 3 months prior to screening and during the Screening Period, or have a medical history of platelet reduction induced by heparin or heparin-induced thrombocytopenia.\n24. Unwilling or unable to comply with the dietary or other guidelines described in this protocol.\n25. Participants who are investigational site staff members directly involved in the conduct of the study or are their family members; site staff members otherwise supervised by the Investigator, or participants who are Nuvation Bio employees directly involved in the conduct of the study.\n26. Venous access considered inadequate for PK sample collection; history or evidence of adverse symptoms associated with phlebotomy or blood donation.\n27. The Investigator judges that the participant is not suitable to participate in the study.",true,"55 Years",{"count":57,"type":20},56,[59],"PHASE1","This Phase 1 open-label trial aims to evaluate the effect of famotidine on the pharmacokinetics (PK), safety and tolerability of taletrectinib in healthy adult participants. To assess famotidine's impact on key PK parameters of taletrectinib and evaluate other PK parameters as well as safety endpoints.\n\nThe study design:\n\nPart 1: Taletrectinib 600 mg administered under 2-hour fasting condition with three regimens: (Treatment A: Taletrectinib alone, Treatment B: Taletrectinib 2 h after single 40 mg famotidine. Treatment C: Taletrectinib dosed between two 20 mg famotidine doses).\n\nPart 2: Taletrectinib 400 mg administered with standard low-fat meal, followed by either Treatment B or C of famotidine co-administration.",[62],"Healthy Adult Participants",[64],"Phase I","2026-07-29",{"date":67,"type":38},"2026-08-03",{"date":69,"type":20},"2026-08-01",{"date":71,"type":20},"2027-02-02",{"name":44,"class":45},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":96,"locationsCount":4},"100647673","phase-3-safety-and-efficacy-study-of-safusidenib-in-participants-with-grade-2-idh1-mutant-glioma-100647673","NCT07712757","Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Safusidenib in Participants With Grade 2 Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma","Key Inclusion Criteria:\n\n* Expected survival of ≥12 months.\n* At least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days (or at least 28 days if biopsy only and postoperative changes have resolved per BICR) and no longer than 5 years before the date of randomization\n* Have not had any other prior anticancer therapy, including chemotherapy and radiotherapy; and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.\n* Histologically confirmed Grade 2, IDH1-mutant oligodendroglioma or astrocytoma according to World Health Organization Central Nervous System 2021 classification criteria per Investigator assessment.\n* IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL), identified by polymerase chain reaction, next-generation sequencing (NGS), or immunohistochemistry; and confirmed 1p19q codeletion status by fluorescence in situ hybridization, NGS, or array comparative genomic hybridization.\n* Residual or recurrent, measurable, non-enhancing disease, as confirmed by BICR per RANO 2.0, assessed at Screening.\n* Adequate hematologic and organ functions\n\nKey Exclusion Criteria:\n\n* Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) for treatment of glioma, including chemotherapy, investigational therapies, prior therapies targeting IDH1 or IDH2, anti-angiogenic therapies, tumor-treating fields, or radiotherapy.\n* High-risk features as assessed by the Investigator, including brainstem or spinal cord involvement either as primary location or by significant tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with ability to comply with protocol requirements).\n* Evidence of leptomeningeal disease.\n* Use of therapeutic doses of steroids for signs\u002Fsymptoms of glioma. Participants taking physiologic doses (defined as equivalent of \\\u003C1.5 mg of dexamethasone equivalent) for medical conditions not related to glioma will be permitted.",{"count":81,"type":20},140,[83],"PHASE3","This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or astrocytoma) with an IDH1 mutation who have undergone surgery as their only treatment and are not in need of immediate chemotherapy or radiotherapy.",[86,33,30,87,88],"Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation","Oligodendroglioma IDH-mutant and 1p\u002F19q-codeleted","IDH-mutant Gliomas",[90,29],"safusidenib","2026-07-14",{"date":93,"type":38},"2026-07-17",{"date":40,"type":20},{"date":42,"type":20},{"name":44,"class":45},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":115,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100462580","phase-3-sigma-safusidenib-in-idh1-mutant-glioma-maintenance-100462580","NCT05303519","SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)","A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma","SIGMA","Key Inclusion Criteria for Part 1:\n\n1. Patient must be ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Patient must have histologically confirmed recurrent or progressive WHO Grade 2 glioma or Grade 3 glioma with IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing.\n3. The IDH mutation, and other applicable gene\u002Fmolecular alterations (see Table 10-2) are determined by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified\u002FCollege of American Pathologists (CAP)-accredited or locally equivalent clinical laboratories. Prior clinical pathology report fulfilling the diagnosis criteria prior to screening with tumor samples collected is acceptable for patient enrollment in both Part 1 and Part 2.\n4. Patient has received no more than 2 prior therapies for disease recurrence\u002Fprogression.\n5. Patient has disease recurrence or progression or cannot tolerate the most recent therapy.\n6. Patient must have a measurable lesion(s) as per the RANO-HGG criteria for primarily enhancing lesions or RANO-LGG criteria for primarily non-enhancing lesions. The lesion (s) must be visible on 2 or more axial slices and have perpendicular diameters of at least 10 × 10 mm. The definition of primarily enhancing lesions or primarily non-enhancing lesions is referred to Section 8.3.1.\n\nKey Inclusion Criteria for Part 2 and 3:\n\n1. Must be ≥18 years old at the time of signing the ICF.\n2. Must agree to submit sufficient tumor tissue for retrospective biomarker and histological analyses. This requirement may be waived in rare circumstances with approval by the Sponsor.\n3. Has adequate hematologic and organ function\n\nKey Inclusion Criteria for Part 2:\n\n1. Diagnosis of histologically confirmed IDH1-mutant Grade 2, Grade 3 with high risk features or Grade 4 astrocytoma, per WHO 2021 classification and Investigator Assessment.\n2. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS). CDKN2A\u002FB status and at least 1 of the following must be confirmed: absence of 1p19q co-deletion by fluorescence in situ hybridization, array comparative genomic hybridization, or NGS; presence of an ATRX loss of function mutation by NGS; or loss of normal ATRX expression by IHC. A validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory must be used for all of the aforementioned results. Documentation of biomarker status, including redacted molecular pathology and NGS reports, must be provided during Screening.\n3. Must not have experienced tumor recurrence or progression between first day of radiotherapy and randomization by local assessment per RANO 2.0.\n4. Participants must have completed radiation therapy with a minimum of 80% of planned treatment completed (with or without concurrent temozolomide) and between 6 and 12 cycles of adjuvant . Randomization must occur at least 28 days and not more than 75 days after the final dose of temozolomide.\n\nKey Inclusion Criteria for Part 3:\n\n1. Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days and no longer than 5 years before the date of enrollment, have not had any other prior anticancer therapy, including chemotherapy and radiotherapy, and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.\n2. Have histologically confirmed Grade 3 IDH-mutant oligodendroglioma according to WHO 2021 criteria per local assessment.\n3. Have residual or recurrent measurable disease per RANO 2.0 and confirmed by BICR, at the time of enrollment.\n4. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL). The presence of 1p19q co-deletion must also be confirmed. All results must be generated using a validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory.\n\nKey Exclusion Criteria for Part 1:\n\n1. Prior anti-cancer therapy, within the applicable periods shown below, before the start of the protocol treatment:\n2. Systemic drug therapies: within 3 weeks (lomustine within 6 weeks)\n3. Surgery: within 3 weeks\n4. Radiation therapy: within 12 weeks\n5. Investigational agents: within 5 half-lives for other investigational agents\n6. Patient did receive the prior therapy targeted to IDH1 mutation..\n7. Known hypersensitivity to safusidenib or to any drug with similar chemical structure or to any other excipient present in the pharmaceutical form of safusidenib.\n\nKey Exclusion Criteria for Part 2 and 3:\n\n1. Participants with prior or anticipated treatment with anti-angiogenic agents such as Avastin (bevacizumab), agents known to target IDH1 or IDH2, or investigational agents for glioma are excluded.\n2. Have brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.\n3. Significant functional or neurocognitive deficits, including uncontrolled seizures, that would preclude participation in protocol-defined study activities, as assessed by Investigator.\n4. Evidence of diffuse leptomeningeal disease.\n5. History of significant cardiac disease within 12 months prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n6. If taking corticosteroids, must be on a stable or decreasing dose for the 14 days prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n7. Participants with other malignancies must have received curative treatment and been disease-free for at least 3 years. Curatively resected skin cancer or curatively treated carcinoma in situ is allowed.\n8. Have a condition that would interfere with, or increase the risk of, study participation.\n\nKey Exclusion Criteria for Part 2 1. Participants may not have received any anticancer treatments other than surgery, radiation, concurrent\u002Fadjuvant temozolomide, and tumor-treating fields. Tumor-treating fields must be discontinued prior to randomization.\n\nKey Exclusion Criteria for Part 3:\n\n1\\. Participants may not have received any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) for treatment of glioma, including radiotherapy.",{"count":106,"type":20},365,[83],"This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent\u002Fprogressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.\n\nThe purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled.\n\nThe purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.",[28,110,29,111,112,113,30,114],"Astrocytoma, Grade IV","Astrocytoma, IDH-Mutant, Grade 3","Astrocytoma, IDH-Mutant, Grade 4","Astrocytoma, IDH-Mutant, Grade 2","Oligodendroglioma, IDH-Mutant and 1p\u002F19q-Codeleted",[90,116,117],"IDH1-mutant glioma","astrocytoma","RECRUITING","2026-06-29",{"date":121,"type":38},"2026-07-01",{"date":123,"type":38},"2023-06-05",{"date":125,"type":20},"2030-12-01",{"name":44,"class":45},57,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100604837","phase-3-phase-3-study-of-taletrectinib-vs-placebo-as-an-adjuvant-therapy-in-ros1-positive-nsclc-trust-iv-100604837","NCT07154706","Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)","A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection","Inclusion Criteria:\n\n1. Histologically confirmed stage IB, II, or IIIA NSCLC (AJCC 9th edition) based on pathological staging.\n2. Documented ROS1 rearrangement in primary tumor by a validated local assay performed in CLIA-certified or locally equivalent diagnostic laboratories.\n3. Adequate tissue is available for prospective central laboratory confirmatory testing. Confirmation of central test positivity is required prior to Randomization.\n\n   Note: In the event that the local testing assay is the same as the central testing assay, and the local test was conducted in a CLIA-certified laboratory or local equivalent, prospective central confirmation is not needed, but tumor tissue must still be provided for other biomarker studies.\n4. Age ≥18 years (or ≥20 years as required by local regulations).\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Received definitive locoregional curative surgery for stage IB, II, or IIIA NSCLC. All surgical margins of resection must be negative for tumor.\n7. Complete recovery from surgery (including complete wound healing) that was performed ≥4 weeks but no more than 16 weeks before Randomization if no adjuvant chemotherapy was given. Surgery must have occurred ≥4 weeks but no more than 30 weeks prior to Randomization if adjuvant chemotherapy was given. For participants who received post-resection adjuvant chemotherapy, the final dose of chemotherapy must also have occurred at least 7 days before Randomization. All chemotherapy related toxicities must have resolved to baseline or ≤Grade 1 (per CTCAE v5.0) prior to Randomization.\n\nExclusion Criteria:\n\n1. Has previously received 1 or more of the following cancer treatments:\n\n   1. Postoperative or planned radiation therapy for the current lung cancer. Note: radiotherapy in the neoadjuvant setting is allowed and must be completed at least 4 weeks prior to Randomization.\n   2. Any adjuvant anticancer therapy (including investigational therapy) for treatment of NSCLC other than standard postoperative platinum-based doublet chemotherapy. Participants should have received no more than 4 cycles of the platinum doublet regimen.\n\n      Notes: Adjuvant immune checkpoint inhibitor (ICI) treatment is allowed, but participants should have received no more than 4 cycles of the ICI, and at the time of Randomization, have at least 12 weeks of washout from the last dose of the ICI. Any prior immune-related toxicity, such as immune-related hepatitis, colitis, or pneumonitis, must be completely resolved prior to Randomization.\n   3. Neoadjuvant chemotherapy with or without ICIs is allowed. Those treated with prior ICIs are eligible if ≥12 weeks have elapsed after completion of the ICI at the time of Randomization. Any prior immune-related toxicity (if an ICI was given), such as immune-related hepatitis, colitis, or pneumonitis, must be completely resolved prior to Randomization.\n   4. Major surgery (including surgical resection of the primary tumor but excluding placement of vascular access port) within 4 weeks of Randomization.\n   5. Segmentectomies or wedge resections, instead of complete resections, of the primary tumor. Note: These limited resections are allowed for patients with stage IB disease with T2aN0M0, with tumor size \\>3 to ≤4 cm, and without visceral pleura or central invasion.\n2. Any investigational therapy for any condition other than NSCLC within 6 months of Randomization.\n3. Co-mutations of epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) fusion.\n4. History of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in situ cancer, or other tumors curatively treated with no evidence of disease for \\>3 years after the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.\n5. Have clinically significant cardiovascular disease within 3 months prior to Randomization.\n6. Have a known history of uncontrolled hypertension.\n7. Experiencing ongoing cardiac dysrhythmias of ≥Grade 2 (CTCAE v5.0), uncontrolled atrial fibrillation of any CTCAE grade, a QT interval corrected by Fridericia's formula (QTcF) of \\>470 milliseconds, symptomatic bradycardia \\\u003C45 bpm; undergoing treatment with medication(s) known to be associated with the development of Torsades de Pointes (TdP).\n8. Have active and clinically significant bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV); or known human immunodeficiency virus (HIV)- or acquired immunodeficiency syndrome-related illness.\n9. Currently have or have a history of interstitial lung disease (ILD), drug-related pneumonitis, or radiation pneumonitis that required steroid treatment.\n10. Use of food or drugs that are known as strong cytochrome P450 (CYP)3A inducers or inhibitors within 14 days prior to Randomization.",{"count":136,"type":20},180,[83],"The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's disease from coming back after the participant's lung tumor was removed.",[140],"Non-small Cell Lung Cancer (NSCLC)",[142,143,144,145,146,147,148],"NSCLC","Adjuvant","ROS1","Stage IB","Stage II","Stage IIIA","Resection","2026-05-17",{"date":151,"type":38},"2026-05-19",{"date":153,"type":38},"2025-08-21",{"date":155,"type":20},"2033-08-30",{"name":44,"class":45},33,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100559453","phase-3-a-phase-iii-study-comparing-taletrectinib-with-standard-therapy-in-ros1-positive-locally-advanced-or-metastatic-non-small-cell-lung-cancer-patients-100559453","NCT06564324","A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients","A Phase 3 Multicenter Open-label Study of Taletrectinib Versus a Standard of Care ROS1-Tyrosine Kinase Inhibitor (Crizotinib) in TKI-Naïve Patients With ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRUST-III)","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of locally advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.\n2. Have documentation of ROS1 rearrangement by a positive result\n3. Have at least 1 measurable (i.e., target) lesion by Investigator assessment per RECIST v1.1.\n4. Prior brain metastases allowed if asymptomatic and diagnosed incidentally at study baseline. If participants have neurological symptoms or signs due to CNS metastasis, participants need to complete local therapy (surgery and\u002For radiation) at least 7 days before enrollment and be clinically stable without requiring for an increasing dose of corticosteroids or use of anticonvulsants to control symptoms.\n5. Age ≥18 years (or ≥20 years as required by local regulations).\n6. Eastern Cooperative Oncology Group (ECOG) performance status zero (0) to 1.\n7. Minimum life expectancy of 3 months or more.\n8. Adequate organ function meeting the following criteria:\n\n   1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤3.0 × upper limit of normal (ULN) (or ≤5.0 × ULN, for participants with concurrent liver metastases).\n   2. Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for participants with Gilbert syndrome).\n   3. Absolute neutrophil count: ≥1500\u002FμL.\n   4. Platelet count: ≥75,000\u002FμL.\n   5. Hemoglobin: ≥9.0 g\u002FdL.\n   6. Estimated creatinine clearance (CLcr) ≥45 mL\u002Fmin as calculated using the method standard for the institution (e.g., Cockcroft-Gault Equation, i.e., CCr={((140-age)×weight)\u002F(72×SCr)}×0.85 (if female) (Cockcroft and Gault 1976).\n9. All toxicities from prior anticancer therapy have resolved to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0), or have resolved to previous baseline, at the time of randomization.\n10. The participant is willing and capable of giving written informed consent.\n\nExclusion Criteria:\n\n1. Previously received an investigational antineoplastic agent for NSCLC.\n2. Previously received any prior TKI, including ROS1-targeted TKIs.\n3. Received immune checkpoint inhibitors for locally advanced or metastatic disease.\n4. Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.\n5. Had major surgery within 28 days prior to randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed.\n6. Have symptomatic CNS metastases at Screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days prior to randomization. Participants with no prior history of signs or symptoms of CNS metastases but who receive prophylactic steroids or anticonvulsants are allowed.\n7. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.\n8. Uncontrolled pleural, abdominal, or pericardial effusion within 28 days prior to randomization, which is associated with malignant effusion requiring recurrent drainage procedures (once monthly or more frequently).\n9. Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively treated nonmetastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n10. Have clinically significant cardiovascular diseases within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral endovascular treatment, heart failure, cerebrovascular disorder including transient ischemic attack, pulmonary embolism, deep venous thrombosis and or other clinically significant thrombosis.\n11. Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.\n12. Have ongoing cardiac dysrhythmias of ≥CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QT interval corrected for heart rate by Fredericia's formula (QTcF) \\>470 milliseconds (female) or \\>450 milliseconds (male), or symptomatic bradycardia \\\u003C45 bpm within 6 months before enrollment; participants treated with medications known to be associated with the development of TdP .\n13. Have active and clinically significant bacterial, fungal, or viral infection including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), known HIV or AIDS-related illness\n14. Currently have or have a history of interstitial lung disease (ILD), drug-related pneumonitis, or radiation pneumonitis that required steroid treatment.\n15. Be pregnant or breastfeeding",{"count":166,"type":20},194,[83],"This is a Phase 3, randomized, open-label, comparative, multicenter, international study for NSCLC patients whose tumor tissue exhibits ROS1 fusion positivity (i.e., ROS1+) and who have not previously received an ROS1-targeted TKI (i.e., ROS1-TKI-naïve).\n\nApproximately 194 ROS-1 TKI- naïve ROS1+NSCLC patients will be randomized in a 1:1 ration to one of 2 study arms:\n\n* Arm A: Taletrectinib monotherapy at 600 mg once daily (QD);\n* Arm B: Crizotinib monotherapy at 250 mg twice daily (BID). Each cycle duration will be 28 days.\n\nParticipants will be stratified by the presence of intracranial metastases at baseline (Yes versus No) and prior chemotherapy use for locally advanced or metastatic disease (Yes versus No). For the purposes of stratification, prior chemotherapy is defined as completion of ≥1 cycle of chemotherapy in the locally advanced or metastatic setting. Participants will be treated until they experience progressive disease (PD) assessed by the BIRC, intolerable toxicity, or another discontinuation criterion is met. Crossover from control group (crizotinib) to taletrectinib is also permitted, at the Investigator's discretion with the Sponsor's approval, for qualifying participants who have experienced objective progression confirmed by the BIRC.",[170],"Non Small Cell Lung Cancer","2026-04-08",{"date":173,"type":38},"2026-04-13",{"date":175,"type":38},"2024-11-27",{"date":177,"type":20},"2030-09",{"name":44,"class":45},29,""]