Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age28-75
SponsorGuangdong Association of Clinical Trials
About this trial
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 criteria
Qualifiers
Signed written informed consent prior to the initiation of any trial-related procedures.
Male or female aged ≥18 years and ≤75 years.
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy.
Disqualifiers
Diagnosis of any malignancy other than non-small cell lung cancer within 5 years prior to the first dose (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been completely resected).
Received adjuvant radiotherapy prior to dosing.
Patients who underwent pneumonectomy.
Currently participating in an interventional clinical study or received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.
Trial design
Treatments tested in this trial
- Sintilimab
Treatment groups
115 Participants
are divided into 1 treatment groupSponsors and collaborators
Guangdong Association of Clinical Trials
Lead sponsor
Zunyi Medical College
Collaborator
Suining Central Hospital
Collaborator
Shenzhen Second People's Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Source ClinicalTrials.gov