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Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)

NCT07120698 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-01-05

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Zunyi Medical College

    collaborator OTHER

  • Suining Central Hospital

    collaborator OTHER

  • Shenzhen Second People's Hospital

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Guangdong Association of Clinical Trials

    lead OTHER

Principal Investigators

  • Yang · Guangdong Association of Clinical Trials

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-05
Primary Completion
2029-06-26
Completion
2029-07-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07120698 on ClinicalTrials.gov