OncoMatch/Clinical Trials/NCT07748325
Adjuvant Immune Checkpoint Inhibitor Versus Observation After Neoadjuvant Immunochemotherapy and Surgery in High-Risk NSCLC
Is NCT07748325 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Sintilimab for non-small cell lung cancer.
Treatment: Sintilimab — This multicenter, randomized, open-label, phase II trial is designed to evaluate the efficacy and safety of adjuvant sintilimab in patients with completely resected non-small cell lung cancer who remain at high risk of recurrence after neoadjuvant immunochemotherapy. Approximately 100 eligible participants will be randomly assigned in a 1:1 ratio to receive either adjuvant sintilimab or observation. Participants assigned to the experimental arm will receive sintilimab at a dose of 200 mg intravenously every 4 weeks for up to 1 year, unless disease recurrence or progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion occurs. The primary outcome is the 18-month disease-free survival rate. Secondary outcomes include disease-free survival, overall survival, and safety. Peripheral blood and tumor tissue samples will also be collected for exploratory analyses of ctDNA, antitumor immune responses, and tumor immune microenvironment biomarkers.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group performance status of 0 or 1
Demographics
Prior therapy
Must have received: immune checkpoint inhibitor — neoadjuvant
Completion of 2 to 4 cycles of neoadjuvant immune checkpoint inhibitor therapy combined with chemotherapy
Must have received: chemotherapy — neoadjuvant
Completion of 2 to 4 cycles of neoadjuvant immune checkpoint inhibitor therapy combined with chemotherapy
Must have received: surgery — definitive resection (R0)
complete (R0) surgical resection
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L; ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 75 × 10^9/L
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN
Cardiac function
Left ventricular ejection fraction ≥ 50%
Adequate organ function within 7 days before randomization, as demonstrated by all of the following: Hemoglobin of at least 90 g/L; Absolute neutrophil count of at least 1.5 × 10^9/L; Platelet count of at least 75 × 10^9/L; Total bilirubin no greater than 1.5 times the upper limit of normal; Alanine aminotransferase and aspartate aminotransferase no greater than 2.5 times the upper limit of normal; Serum creatinine no greater than 1.5 times the upper limit of normal or creatinine clearance of at least 60 mL/min; Left ventricular ejection fraction of at least 50%; International normalized ratio or prothrombin time no greater than 1.5 times the upper limit of normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07748325 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received immune checkpoint inhibitor and chemotherapy.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages