RecruitingPhase 2NCT07120698

Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)

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

Sponsor

Guangdong Association of Clinical Trials

Enrollment

115 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Conditions

MRD NSCLC (Non-small Cell Lung Cancer)II-IIIB Stages Adjuvant Immunotherapy

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.

Eligibility

Min Age: 28 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a blood test called MRD (minimal residual disease) testing can guide decisions about adjuvant immunotherapy in patients with non-small cell lung cancer (NSCLC) after surgery. Patients who received pre-surgery chemotherapy and immunotherapy and then had complete surgical removal of their tumor will receive or skip additional immunotherapy (sintilimab) based on whether cancer DNA is still detectable in the blood. **You may be eligible if...** - You are aged 18–75 with confirmed NSCLC - You received 3–4 cycles of pre-surgery immunotherapy (a PD-1 inhibitor) plus chemotherapy - You had complete surgical removal of your tumor (R0 resection) with no cancer remaining - Your pathology shows a major or complete response to pre-surgery treatment - Your overall health allows for further immunotherapy **You may NOT be eligible if...** - Your surgery did not achieve complete removal of the tumor - You had prior surgery or treatment for NSCLC other than the approved pre-surgery protocol - You have active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSintilimab

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