Adjuvant Immune Checkpoint Inhibitor Versus Observation After Neoadjuvant Immunochemotherapy and Surgery in High-Risk NSCLC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat
- •Potwierdzony rak płuca typu nie-drobnokomórkowy
- •Zakończone leczenie przedoperacyjne chemio-immunologiczne i całkowita operacyjna usunięcie guza
- •Co najmniej jeden czynnik ryzyka nawrotu nowotworu (zmienione węzły chłonne, zaawansowana zmiana, pozostałe komórki nowotworowe lub cechy niepomyślne)
- •Przy raku typu gruczoł - brak mutacji EGFR i zmian ALK
- •Dobry ogólny stan zdrowia (0-1 w skali ECOG)
- •Prawidłowe wyniki badań krwi i funkcji narządów wewnętrznych
- •Kobiety w wieku rozrodczym muszą stosować skuteczną antykoncepcję
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- August 5, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
West China Hospital, Sichuan University
Chengdu, China
Suining Central Hospital
Suining, China
Trial contact
zhenyu ding, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/6/2026.
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