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RECRUITING
NCT07120698
PHASE2

Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)

Sponsor: Guangdong Association of Clinical Trials

View on ClinicalTrials.gov

Summary

This is a multicenter, prospective, open-label Phase II study designed to evaluate the safety and efficacy of adjuvant sintilimab therapy guided by minimal residual disease (MRD) in patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who have not achieved a pathological complete response (non-pCR) after neoadjuvant immunotherapy combined with chemotherapy. The study is being conducted at the Third People's Hospital of Chengdu and the Guangdong Provincial People's Hospital.

Official title: Adaptive Adjuvant Sintilimab Therapy Guided by MRD in II-IIIB Stage NSCLC Patients With Non-pCR Pathological Response After Neoadjuvant Immunotherapy Combined With Chemotherapy: a Prospective, Multi-center, Single-arm, Phase II Trial

Key Details

Gender

All

Age Range

28 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2025-11-05

Completion Date

2029-07-26

Last Updated

2026-01-05

Healthy Volunteers

No

Interventions

DRUG

Sintilimab

Patients who met the inclusion criteria were treated with adaptive adjuvant sintilimab therapy guided by MRD. Patients should test twice at postoperative days 3 to 7 and again at postoperative day 28 (±3 days). The results of these two tests will be used to determine the subsequent treatment pathway. Participants with two consecutive positive MRD tests or a single positive MRD test will be enrolled in the MRD+ treatment cycle:they will receive adjuvant treatment with sintilimab (200 mg, intravenous infusion, every 3 weeks). Follow-up visits will be conducted every 3 months, during which chest CT scans and MRD testing will be performed. If MRD becomes negative, treatment will be discontinued and the participant will be monitored. If MRD remains positive, treatment with sintilimab will continue. Participants with two consecutive negative MRD tests will be enrolled in the MRD- treatment cycle:they will undergo follow-up observation only. Follow-up visits will be conducted every 3 months

Locations (2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The third people's hospital of chengdu

Chengdu, Sichuan, China