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

NCT07362459 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2026-01-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2027-07-31
Completion
2029-09-30

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 NCT07362459 on ClinicalTrials.gov