Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

August 26, 2025

Primary Completion Date

June 26, 2029

Study Completion Date

July 26, 2029

Conditions
NSCLC (Non-small Cell Lung Cancer)MRDII-IIIB StagesAdjuvant Immunotherapy
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"

All Listed Sponsors
collaborator

Zunyi Medical College

OTHER

collaborator

Suining Central Hospital

OTHER

collaborator

Shenzhen Second People's Hospital

OTHER

collaborator

Guangdong Provincial People's Hospital

OTHER

lead

Guangdong Association of Clinical Trials

OTHER