Adjuvant Immune Checkpoint Inhibitor Versus Observation After Neoadjuvant Immunochemotherapy and Surgery in High-Risk NSCLC

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 toxic

Trial Details

NCT ID
NCT07748325
Phase
PHASE2
Sponsor
Sichuan University
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Sintilimab
Locations (sample)
  • Chengdu, Sichuan, China|30.66667,104.06667
  • Suining, Sichuan, China|30.50802,105.57332

Key Eligibility Criteria

  • Male or female participants aged 18 to 75 years.
  • Histologically or cytologically confirmed non-small cell lung cancer.
  • Completion of 2 to 4 cycles of neoadjuvant immune checkpoint inhibitor therapy combined with chemotherapy, followed by complete (R0) surgical resec…
  • At least one of the following protocol-defined high-risk features for postoperative recurrence:

For full eligibility, visit ClinicalTrials.gov.

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