Adjuvant Immune Checkpoint Inhibitor Versus Observation After Neoadjuvant Immunochemotherapy and Surgery in High-Risk NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Pathologic lymph-node involvement;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Sintilimab
DrugSintilimab will be administered at a dose of 200 mg by intravenous infusion once every 4 weeks for up to 1 year. Treatment will continue until completion of the planned treatment period, disease recurrence, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Adjuvant SintilimabExperimental treatment 1 intervention
Group B: ObservationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
18-Month Disease-Free Survival Rate
The Kaplan-Meier estimated proportion of participants who are alive and free from local recurrence, regional recurrence, distant metastasis, or death from any cause at 18 months after definitive surgery. Participants without a documented disease-free survival event will be censored at the date of their last disease assessment.
Time frame
At 18 months after definitive surgerySecondary outcomes
1
Overall Survival
Overall survival is defined as the time from the date of initial histopathologic diagnosis to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.
Time frame
From the date of initial histopathologic diagnosis until death from any cause, assessed up to 36 months.2
Incidence of Adverse Events
The incidence, severity, seriousness, and relationship to study treatment of adverse events and serious adverse events will be assessed. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Time frame
From informed consent through 30 days after completion or discontinuation of the protocol-defined treatment，up to approximately 1 years.3
Disease-Free Survival
Disease-free survival is defined as the time from the date of definitive surgery to the first documented local recurrence, regional recurrence, distant metastasis, or death from any cause, whichever occurs first. Participants without a documented event will be censored at the date of the last disease assessment.
Time frame
From the date of definitive surgery until the first documented disease recurrence or death from any cause, assessed up to 36 months.Other outcomes
1
Circulating Tumor DNA at Prespecified Time Points
Time frame
At baseline before randomization and at 3, 6, 9, 12, and 18 months after randomizationSponsors and contacts
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Source ClinicalTrials.gov