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SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
Sponsor: Sinocelltech Ltd.
Summary
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
410
Start Date
2026-05-09
Completion Date
2030-01-24
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
SCTB41
IV infusion,Specified dose on specified days.
Tislelizumab
IV infusion,Specified dose on specified days.
Paclitaxel
175 mg/m², IV infusion, Q3W, for 4 cycles.
Nab-paclitaxel
100 mg/m², IV infusion, on Days 1, 8, 15 of each 3-week cycle, for 4 cycles
Carboplatin
AUC 5, IV infusion, Q3W, for 4 cycles.
Cisplatin
75 mg/m², IV infusion, Q3W, for 4 cycles.
Pemetrexed
500 mg/m², IV infusion, Q3W, for 4 cycles .
Locations (1)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China