[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658821":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":40,"overallOfficials":26,"centralContacts":46,"locations":26,"responsibleParty":52,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":26,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":26,"overallStatus":73,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":26},{"fullName":5,"class":6},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"The safety of SKB264 in combination with SKB118 in participants with non-squamous non-small cell lung cancer (NSCLC)","Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] v6.0)","From enrollment to the end of treatment at 24 months",{"measure":14,"description":15,"timeFrame":12},"ORR(objective response rate)","ORR as assessed by the investigator based on RECIST v1.1",[17,20,22,24],{"measure":18,"description":19,"timeFrame":12},"DCR(Disease control rate )","as assessed by the investigator based on RECIST v1.1",{"measure":21,"description":19,"timeFrame":12},"DOR(duration of response )",{"measure":23,"description":19,"timeFrame":12},"PFS(progression-free survival)",{"measure":25,"description":26,"timeFrame":12},"OS (overall survival)",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"SKB264 in combination with SKB118","EXPERIMENTAL","SKB264 (4 mg\u002Fkg or other dose levels) combined with SKB118 (10 mg\u002Fkg, 20 mg\u002Fkg, or other dose levels).",[39],"Drug: SKB264+SKB118",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":26},"DRUG","SKB264+SKB118","Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.",[35],[47],{"name":48,"role":49,"phone":50,"phoneExt":26,"email":51},"Xiaoping Jin, PhD","CONTACT","028-67255495","jinxp@kelun.com",{"type":53,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100658821","phase-2-a-phase-ii-study-of-skb264--skb118-in-nsq-nsclc-after-egfr-tki-failure-100658821",false,"NCT07854509","A Phase II Study of SKB264 + SKB118 in Nsq-NSCLC After EGFR-TKI Failure","A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer in Participants Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-squamous NSCLC that is not suitable for radical surgery and\u002For radical radiotherapy (regardless of whether concurrent chemotherapy has been received).\n2. Confirmed EGFR-sensitizing mutations.\n3. Participants must have failed prior EGFR-TKI therapy for locally advanced or metastatic disease.\n4. Participants must be confirmed during the screening period to be able to provide a tumor tissue sample. If this cannot be met, acceptability should be discussed with the medical monitor.\n5. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n6. ECOG performance status of 0 or 1.\n7. Life expectancy ≥ 12 weeks.\n8. Adequate bone marrow, liver, kidney, and coagulation function.\n9. Male and female participants must agree to use highly effective contraceptive measures during the specified period of the study.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma components, or with a squamous component of more than 10%.\n2. Presence of known driver gene alterations with approved targeted therapies.\n3. Participants with known metastases to meninges, brainstem metastases, spinal cord metastases and\u002For compression, active or untreated brain metastases.\n4. Participants with other malignant tumors within 3 years prior to the first dose.\n5. Presence of uncontrolled, or symptomatic, or recurrent pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n6. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy, current ILD or non-infectious pneumonia.\n7. Presence of other moderate to severe lung disorders that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function.\n8. Risk of developing esophago-tracheal fistula or esophago-pleural fistula, or tumor invasion or compression of surrounding vital organs and major blood vessels.\n9. History of hemorrhagic diathesis or coagulopathy and\u002For clinically significant bleeding symptoms or risks.\n10. Previous or concurrent gastrointestinal diseases, surgery, and wound healing complications.\n11. Unresolved toxicity from prior anti-tumor therapy, defined as toxicity not recovered to Grade 0 or 1 of CTCAE v6.0, or to the level specified in the inclusion\u002Fexclusion criteria, with the exception of alopecia.\n12. Serious infection within 4 weeks before the first dose, active infection requiring systemic anti-infective therapy within 2 weeks before the first dose.\n13. Presence of active hepatitis B or hepatitis C or co-infection with HBV and HCV.\n14. Positive human immunodeficiency virus (HIV) test or known history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n15. Known active tuberculosis.\n16. Known history of allogeneic organ transplant or hematopoietic stem cell transplant.\n17. With Grade ≥ 2 peripheral neuropathy.\n18. Active autoimmune disease requiring systemic treatment within the past two years.\n19. Participants who have received any of the following systemic anti-tumor therapies (including in the adjuvant or neoadjuvant setting):\n\n    1. Prior treatment with immune checkpoint inhibitors, immune checkpoint agonists, or any therapy targeting the immune mechanism of the tumor, such as immune cell therapy.\n    2. Prior treatment with PD-(L)1\u002FVEGF bispecific antibodies or therapies targeting VEGF\u002FVEGFR with monoclonal antibodies or small molecules.\n    3. Therapy targeting TROP2.\n    4. Any drug therapy targeting topoisomerase I, including antibody-drug conjugate (ADC) therapy.\n20. Pregnant or lactating women.","ALL","18 Years","75 Years",{"count":65,"type":66},110,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitizing mutations who have failed EGFR-TKI therapy. The study includes a dose escalation phase and an expansion phase.",[72],"Non-Squamous Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-10-01",{"date":76,"type":77},"2026-10-02","ACTUAL",{"date":79,"type":66},"2026-10-15",{"date":81,"type":66},"2029-12-30",{"name":5,"class":6}]