Adjuvant Immune Checkpoint Inhibitor Versus Observation After Neoadjuvant Immunochemotherapy and … (NCT07748325) | Clinical Trial Compass
RecruitingPhase 2
Adjuvant Immune Checkpoint Inhibitor Versus Observation After Neoadjuvant Immunochemotherapy and Surgery in High-Risk NSCLC
China100 participantsStarted 2025-01-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 resection.
. At least one of the following protocol-defined high-risk features for postoperative recurrence:
. For participants with lung adenocarcinoma, absence of sensitizing EGFR mutations and ALK rearrangements. Molecular testing is not mandatory for participants with squamous cell carcinoma according to the current protocol.
. Eastern Cooperative Oncology Group performance status of 0 or 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Adequate organ function within 7 days before randomization, as demonstrated by all of the following:
. Women of childbearing potential must have a negative pregnancy test within 7 days before the first dose and must agree to use effective contraception during the study and for 3 months after the last dose of study treatment. Male participants with partners of childbearing potential must agree to use effective contraception during the study and for 8 weeks after the last dose.
Exclusion criteria
. Small cell lung cancer or non-small cell lung cancer containing a small cell carcinoma component.
. Incomplete resection, including R1 or R2 resection, or salvage surgery.
. Clinically significant malnutrition as determined by the investigator.
. A history of clinically significant immune-related adverse events during prior treatment, including grade 3 or higher immune-mediated pneumonitis, myocarditis, or another serious immune-related adverse event that, in the investigator's judgment, makes further immune checkpoint inhibitor therapy unsafe.
. Signs, symptoms, or a known history of clinically significant interstitial lung disease.
. Any severe or uncontrolled concurrent medical condition, including:
. A concurrent active malignancy, except for malignancies specifically permitted by the final protocol.
. An active autoimmune disease or another immune-mediated disease requiring systemic treatment.