Actively Recruiting
Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)
Led by Guangdong Association of Clinical Trials · Updated on 2026-01-05
115
Participants Needed
2
Research Sites
194 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
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
Official 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 starting any trial procedures
- Male or female aged 18 to 75 years
- Confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Received 3 to 4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy
- Underwent radical lung surgery (lobectomy or sleeve lobectomy) with complete tumor removal and negative surgical margins
- Clinical stage II, IIIA, or IIIB (limited to resectable N2) according to staging guidelines
- Pathological response showing 1% to 90% residual viable tumor
- No EGFR mutations, ROS1, ALK, or RET gene fusions
- No prior anti-tumor treatments except PD-1 inhibitors and chemotherapy before surgery
- Completed surgery 4 to 12 weeks before enrollment with no residual tumor seen on scans one month after surgery
- ECOG performance status of 0 to 1
- Life expectancy greater than 6 months
- Adequate organ function including specific blood counts, liver and kidney function, coagulation, thyroid, and cardiac enzyme levels
- Negative pregnancy test for women of childbearing potential before first treatment
- Use of effective contraception during treatment and for 120 days after last drug dose
- Willingness to provide tissue and blood samples for MRD testing
You will not qualify if you...
- Any other cancer diagnosis within 5 years prior to study drug except fully treated certain skin cancers
- Received adjuvant radiotherapy before study drug dosing
- Underwent pneumonectomy
- Participation in other interventional clinical trials or use of investigational drugs/devices within 4 weeks before dosing
- Received neoadjuvant anti-tumor treatments other than chemotherapy and immunotherapy
- Presence of unhealed surgical wounds, ulcers, or fractures
- Severe systemic diseases that could affect study completion or autoimmune diseases requiring systemic treatment
- Primary immunodeficiency diseases
- Use of systemic corticosteroids within 7 days before first dose (except low-dose physiologic corticosteroids)
- History of allogeneic organ or hematopoietic stem cell transplantation (excluding corneal transplant)
- Known allergy to sintilimab or its ingredients
- Not fully recovered from toxicities or complications of prior treatments beyond mild or baseline levels
AI-Screening
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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
CONTACT
B
Benyuan Jiang
CONTACT
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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