NCT07120698

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 28 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with Stage II-IIIB NSCLC who have not achieved a pathological complete response after neoadjuvant immunotherapy combined with chemotherapy will be enrolled in this study. Eligible patients will receive adjuvant sintilimab therapy guided by MRD. Patients should undergo a test 3 to 7 days after surgery, and another test 28 days (±3 days) after. surgery The results of these two tests will be used to determine the subsequent treatment pathway. Participants with two consecutive positive MRD test results or a single positive MRD test result will be included in the MRD + treatment cycle: they will receive adjuvant therapy with sintilimab (200 mg, intravenous infusion, every 3 weeks). Follow-up will be conducted every 3 months, during which chest CT scans and MRD tests will be performed. If the MRD test result turns negative, treatment will be discontinued and participants will be monitored. If the MRD test result remains positive, sintilimab treatment will continue. Participants with two consecutive negative MRD test results will be included in the MRD - treatment cycle: they will only receive follow-up observation. Follow-up will be conducted every 3 months, during which chest CT scans and MRD tests will be performed. If the MRD test result turns positive, adjuvant therapy with sintilimab (200 mg, intravenous infusion, every 3 weeks) will be initiated. If the MRD test result remains negative, follow-up observation will continue. The maximum number of treatment cycles for sintilimab therapy is 18 cycles. Safety will be evaluated through adverse events (AE) and laboratory tests.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-05
• Primary completion: 2029-06-26
• Completion: 2029-07-26
• First posted: 2025-08-13
• Last updated: 2026-01-05

Locations

2 sites across 1 country: China