NCT07362459

A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.

A Phase III, Randomized, Double-blind, Multicenter Clinical Study to Evaluate the Efficacy and Safety of SCTB14 Versus Pembrolizumab as First-Line Therapy in Patients With Driver Gene-Negative, TPS ≥10% Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival. Safety will be closely monitored.

Conditions

• Non-Small Cell Lung Carcinoma (NSCLC)

Interventions

Type	Name	Description
DRUG	SCTB14	SCTB14 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle.
DRUG	Pembrolizumab	Pembrolizumab is administered at a fixed dose of 200 mg by intravenous infusion on Day 1 of each 3-week cycle.

Timeline

• Start date: 2025-12-30
• Primary completion: 2027-07-01
• Completion: 2029-09-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: China