RecruitingPhase 3NCT07362459

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


Sponsor

Sinocelltech Ltd.

Enrollment

246 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SCTB14 as a first-line treatment for people with advanced or metastatic non-small cell lung cancer (NSCLC) — a common form of lung cancer that has spread or cannot be removed surgically. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with advanced or metastatic NSCLC that cannot be cured with surgery or radiation - You are in generally good physical condition (able to carry out daily activities) - Your expected survival is at least 3 months - Your lung cancer does not have EGFR or ALK mutations (if non-squamous type) **You may NOT be eligible if...** - You have already received prior chemotherapy or immunotherapy for this stage of lung cancer - Your tumor has EGFR or ALK mutations (specific targeted therapies exist for those) - You are not well enough to participate in a clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSCTB14

SCTB14 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle.

DRUGPembrolizumab

Pembrolizumab is administered at a fixed dose of 200 mg by intravenous infusion on Day 1 of each 3-week cycle.


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT07362459


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