A Multicenter Phase II/III Study Evaluating the Efficacy and Safety of SCTB41 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Driver-Negative Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
This is a multicenter Phase II/III study evaluating the efficacy and safety of SCTB41 combined with chemotherapy versus tislelizumab combined with chemotherapy as first-line treatment in patients with driver-negative locally advanced or metastatic non-small cell lung cancer (NSCLC). The Phase II portion is an open-label safety run-in study enrolling approximately 30-60 patients to evaluate the safety and tolerability of SCTB41 plus chemotherapy. Following confirmation of acceptable safety and preliminary efficacy, the study will proceed to the Phase III portion. The Phase III portion is a randomized, double-blind, active-controlled study enrolling approximately 350 patients. Eligible participants will be randomized in a 1:1 ratio to receive SCTB41 plus chemotherapy or tislelizumab plus chemotherapy. The primary objective is to compare progression-free survival assessed by blinded independent central review according to RECIST version 1.1.
• Voluntary written informed consent (ICF) signed prior to screening.
• Age ≥18 years, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Expected survival ≥3 months.
• Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and is not suitable for definitive concurrent or sequential chemoradiotherapy, according to the 9th edition of the TNM staging system by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC).
• For subjects with adenocarcinoma, non-smokers, or squamous cell carcinoma with mixed adenocarcinoma components, absence of sensitizing EGFR mutations (e.g., exon 19 deletion, exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I) or ALK gene rearrangements must be confirmed by tumor tissue, cytology, or blood samples prior to enrollment.
• Availability of tumor tissue samples for PD-L1 testing.
• No prior systemic anticancer therapy for the study disease.
• At least one measurable lesion (excluding brain lesions) per RECIST v1.1. 10 Adequate organ function.