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

NCT07662395 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2026-06-23

No results posted yet for this study

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.

Conditions

  • Double Blind

Interventions

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 .

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

SCTB41

IV infusion,Specified dose on specified days.

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-09
Primary Completion
2030-01-24
Completion
2030-01-24

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07662395 on ClinicalTrials.gov