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Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC

NCT07120282 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-03-09

No results posted yet for this study

Summary

A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC

Conditions

  • Lung Cancer (NSCLC)

Interventions

DRUG

Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group

Tislelizumab 400 mg iv, q6w, for up to 1 year; patients are permitted to receive concurrent adjuvant platinum-based doublet chemotherapy (q3w, up to 4 cycles) starting from the first dose of tislelizumab; during concurrent chemotherapy, a tislelizumab dosage of 200 mg iv, q3w is allowed.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2029-08-15
Completion
2030-12-31

Countries

  • China

Study Locations

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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 NCT07120282 on ClinicalTrials.gov