Actively Recruiting
Adaptive Adjuvant Sintilimab Therapy Guided by MRD in Stage II-IIIB NSCLC Patients Without Complete Response After Neoadjuvant Immunotherapy and Chemotherapy
Led by Guangdong Association of Clinical Trials · Updated on 2026-01-05
115
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
G
Guangdong Association of Clinical Trials
Lead Sponsor
Z
Zunyi Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of adjuvant sintilimab therapy guided by minimal residual disease (MRD) in patients with Stage II to IIIB non-small cell lung cancer (NSCLC) who did not achieve a complete pathological response after receiving neoadjuvant immunotherapy combined with chemotherapy. This is a multicenter, prospective, open-label Phase II trial led by the Guangdong Association of Clinical Trials, aiming to improve outcomes in NSCLC patients post-surgery. Eligible patients undergo two MRD tests after surgery—one between 3 to 7 days and another around 28 days post-operation. Those with positive MRD results receive sintilimab infusions (200 mg intravenously every three weeks) for up to 18 cycles, with treatment continuing or stopping based on subsequent MRD test results. Patients with negative MRD results enter a follow-up observation period with chest CT scans and MRD testing every three months; sintilimab treatment starts if MRD becomes positive during follow-up. Participants will be monitored through regular chest CT scans and MRD tests every three months during follow-up. Researchers will assess safety through adverse events and lab tests, and measure outcomes such as the two-year event-free survival rate. The study includes long-term monitoring of overall survival and quality of life for up to 24 months, with some assessments extending to 100 months after enrollment.
CONDITIONS
Brief Title
Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any trial procedures
- Male or female aged 18 to 75 years
- Confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Completed 3-4 cycles of neoadjuvant immunotherapy combined with chemotherapy
- Underwent complete surgical removal of lung tumor (lobectomy or sleeve lobectomy) with negative margins and systemic lymph node dissection
- Clinical stage II, IIIA, or IIIB with resectable N2 disease as defined
- Pathological residual viable tumor between 1% and 90%
- No EGFR, ROS1, ALK, or RET gene alterations
- No prior anti-tumor treatments other than PD-1 inhibitors and chemotherapy before surgery
- Surgery completed 4-12 weeks before enrollment with no residual tumor on imaging
- ECOG performance status 0-1
- Life expectancy greater than 6 months
- Adequate organ function including blood counts, liver, kidney, coagulation, thyroid, and heart function
- Negative pregnancy test for women of childbearing potential
- Use of effective contraception during treatment and for 120 days after last study drug dose
- Willing to provide samples for MRD testing (surgical tissue and blood)
You will not qualify if you...
- Any other cancer diagnosis within 5 years except fully treated certain skin cancers
- Received adjuvant radiotherapy before study drug
- Underwent pneumonectomy
- Participation in other interventional studies or use of investigational drugs/devices within 4 weeks prior
- Received neoadjuvant treatments other than chemotherapy and immunotherapy
- Presence of unhealed wounds, ulcers, or fractures
- Severe systemic diseases affecting ability to complete study
- Autoimmune diseases requiring systemic treatment
- Primary immunodeficiency diseases
- Systemic corticosteroid use within 7 days before study drug (except low-dose)
- History of organ or stem cell transplantation (excluding corneal)
- Allergy to sintilimab or its components
- Not fully recovered from prior treatment toxicities above Grade 1 except fatigue or hair loss
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - From 3 to 7 days and again at 28 days (±3 days) after surgery
Participants undergo MRD testing twice after surgery to guide their treatment pathway.
2 visits for MRD testing
Duration - Up to 18 treatment cycles of 3 weeks each
Participants with positive MRD test results receive adjuvant sintilimab therapy (200 mg intravenous infusion every 3 weeks). Treatment continues until MRD tests turn negative or up to 18 cycles maximum.
Infusions every 3 weeks; follow-up visits every 3 months with chest CT scans and MRD tests
Duration - Up to 2 years or until disease progression
Participants with negative MRD test results are monitored with follow-up visits every 3 months including chest CT scans and MRD testing. Treatment may be initiated if MRD becomes positive.
Quarterly follow-up visits every 3 months
Trial Site Locations
Total: 2 locations
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
2
The third people's hospital of chengdu
Chengdu, Sichuan, China, 610031
Actively Recruiting
Research Team
Y
Yi Yang
B
Benyuan Jiang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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