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RECRUITING
NCT07662395
PHASE2/PHASE3

SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer

Sponsor: Sinocelltech Ltd.

View on ClinicalTrials.gov

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

DRUG

SCTB41

IV infusion,Specified dose on specified days.

DRUG

Tislelizumab

IV infusion,Specified dose on specified days.

DRUG

Paclitaxel

175 mg/m², IV infusion, Q3W, for 4 cycles.

DRUG

Nab-paclitaxel

100 mg/m², IV infusion, on Days 1, 8, 15 of each 3-week cycle, for 4 cycles

DRUG

Carboplatin

AUC 5, IV infusion, Q3W, for 4 cycles.

DRUG

Cisplatin

75 mg/m², IV infusion, Q3W, for 4 cycles.

DRUG

Pemetrexed

500 mg/m², IV infusion, Q3W, for 4 cycles .

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China