A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients (NCT05870319) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients
China376 participantsStarted 2023-06-26
Plain-language summary
This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males or females aged ≥18 to ≤75 years at the time of signing the ICF;
✓. Histologically or cytologically confirmed non-squamous NSCLC and locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical concurrent/sequential chemoradiotherapy;
✓. EGFR-sensitive mutations;
✓. Failure of prior EGFR-TKI therapy;
✓. At least one measurable target lesion per RECIST 1.1 as assessed by the investigator;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
✓. Expected survival ≥12 weeks;
✓. Adequate organ and bone marrow function;
Exclusion criteria
✕. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;
✕. Other malignancies within 3 years prior to the first dose;
✕. History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis;
✕. Subjects with active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tract bleed;
What they're measuring
1
Progression-free survival (PFS)
Timeframe: From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months
✕. Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1 (per NCI CTCAE 5.0) or to the level specified in the eligibility criteria;
✕. Subjects with human immunodeficiency virus (HIV) test positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
✕. Prior TROP2-targeted therapy;
✕. Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);