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RECRUITING
NCT07748325
PHASE2

Adjuvant Immune Checkpoint Inhibitor Versus Observation After Neoadjuvant Immunochemotherapy and Surgery in High-Risk NSCLC

Sponsor: Sichuan University

View on ClinicalTrials.gov

Summary

This multicenter, randomized, open-label, phase II trial is designed to evaluate the efficacy and safety of adjuvant sintilimab in patients with completely resected non-small cell lung cancer who remain at high risk of recurrence after neoadjuvant immunochemotherapy. Approximately 100 eligible participants will be randomly assigned in a 1:1 ratio to receive either adjuvant sintilimab or observation. Participants assigned to the experimental arm will receive sintilimab at a dose of 200 mg intravenously every 4 weeks for up to 1 year, unless disease recurrence or progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion occurs. The primary outcome is the 18-month disease-free survival rate. Secondary outcomes include disease-free survival, overall survival, and safety. Peripheral blood and tumor tissue samples will also be collected for exploratory analyses of ctDNA, antitumor immune responses, and tumor immune microenvironment biomarkers.

Official title: Adjuvant Immune Checkpoint Inhibitor Versus Observation in Patients With Completely Resected Non-Small Cell Lung Cancer at High Risk of Recurrence After Neoadjuvant Immunochemotherapy: A Multicenter, Randomized, Open-Label, Phase II Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-01-10

Completion Date

2028-12-30

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

DRUG

Sintilimab

Sintilimab will be administered at a dose of 200 mg by intravenous infusion once every 4 weeks for up to 1 year. Treatment will continue until completion of the planned treatment period, disease recurrence, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion.

Locations (2)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Suining Central Hospital

Suining, Sichuan, China