Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07362459

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

Led by Sinocelltech Ltd. · Updated on 2026-01-23

246

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Voluntarily sign informed consent before screening
  • ECOG Performance Status of 0 to 1
  • Expected survival of at least 3 months
  • Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC not suitable for surgery or radical chemoradiotherapy
  • For non-squamous and certain non-smoking squamous cell carcinoma patients, confirmed absence of EGFR sensitizing mutations or ALK gene rearrangements
  • Provide histology sample suitable for PD-L1 testing with Tumor Proportion Score (TPS) of 10% or higher
  • No prior systemic anti-tumor therapy for this disease
  • At least one measurable non-central nervous system lesion per RECIST v1.1
  • Adequate major organ function
Not Eligible

You will not qualify if you...

  • Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E, NTRK fusion, MET exon 14 skipping, or RET fusion
  • Recent use of non-specific immunomodulatory or immunosuppressive drugs within 2 weeks before first dose
  • Traditional Chinese medicine with anti-cancer effects within 1 week before first dose
  • Prior thoracic radiotherapy or local anti-tumor therapy within 2 weeks before dosing
  • Previous treatment with immunotherapy, antiangiogenic therapy, or tyrosine kinase inhibitors
  • Brainstem, meninges, spinal cord metastasis or active/multiple brain metastases
  • Tumor invasion of major blood vessels, significant necrosis, cavitation, or lymphangitic carcinomatosis
  • Tumor invasion or compression of vital organs or risk of esophageal fistula
  • History of hypertensive crisis, uncontrolled hypertension, or poorly controlled diabetes
  • Recent history (within 6 months) of arterial or venous thrombosis, stroke, or significant vascular disease
  • Recent history (within 6 months) of myocardial infarction, unstable angina, severe heart failure, or uncontrolled arrhythmia
  • Active or history of autoimmune disease with expected recurrence
  • Recent serious gastrointestinal conditions within 6 months
  • History of bleeding disorders or high bleeding risk
  • Presence of other malignant tumors
  • Unresolved toxicities from prior treatments above Grade 1
  • Live or attenuated vaccine use within 4 weeks before first dose or planned during study
  • Active infections including severe infection, tuberculosis, HIV, hepatitis B or C, or syphilis
  • Planned major surgery or unhealed wounds before enrollment
  • Symptomatic or recurrent effusions requiring drainage
  • History of non-infectious pneumonia or interstitial lung disease
  • History of allogeneic organ or stem cell transplantation
  • Known hypersensitivity to study drugs or monoclonal antibodies
  • Participation in another clinical trial except observational or follow-up phases
  • Pregnancy or breastfeeding
  • History of substance addiction, psychiatric disorders, or drug abuse
  • Tumor-related conditions with high medical risk
  • Any other condition judged inappropriate for enrollment by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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