OncoMatch/Clinical Trials/NCT07662395
SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
Official title: 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)
Is NCT07662395 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2/3 trial studies multiple treatments for double blind.
Treatment: SCTB41 · Tislelizumab · Paclitaxel · Nab-paclitaxel · Carboplatin · Cisplatin · Pemetrexed — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
absence of ... ALK gene rearrangements
Excluded: EGFR sensitizing mutation
absence of sensitizing EGFR mutations (e.g., exon 19 deletion, exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I)
Excluded: ROS1 fusion
Known ROS1 fusion-positive
Excluded: BRAF v600e
BRAF V600E mutation
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Prior therapy
Cannot have received: thoracic radiotherapy
Lab requirements
Blood counts
Adequate organ function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07662395 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR sensitizing mutation is an exclusion criterion.
Are patients with ROS1 alterations eligible?
No. ROS1 fusion is an exclusion criterion.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages