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

Recruiting Phase 2 Interventional Study
Non-Small Cell Lung Cancer Adjuvant Therapy Immune Checkpoint Inhibitors
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Sichuan University · Other
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About This 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 observati…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female participants aged 18 to 75 years. 2. Histologically or cytologically confirmed non-small cell lung cancer. 3. Completion of 2 to 4 cycles of neoadjuvant immune checkpoint inhibitor therapy combined with chemotherapy, followed by complete (R0) surgical resection…
Contacts

zhenyu ding, MD

+86 028-854-22562

dingzhenyu@scu.edu.cn

CONTACT