Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
NCT Number: NCT06498635
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Lung Non-Small Cell Carcinoma|Stage II Lung Cancer AJCC v8|Stage IIIA Lung Cancer AJCC v8|Stage IIIB Lung Cancer AJCC v8
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Computed Tomography|BIOLOGICAL: Durvalumab|OTHER: Patient Observation|OTHER: Questionnaire Administration
Sponsor: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 306
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-03-14
Completion Date: 2039-07-15

Summary:
This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.

Primary Outcome Measures: Disease-free survival, Will be assessed using a 1-sided 5% level log-rank test accounting for interim testing, stratified on the randomization stratification factors., From date of randomization to the earliest event defined as date of first documentation of recurrence, any new lung cancer (even in the contralateral lung), or death due to any cause, assessed up to 10 years
Secondary Outcome Measures: Event-free survival (EFS), EFS events are defined as: Discontinuation of durvalumab (MEDI4736) due to toxicity, either immune or non-immune related, any new lung cancer (even in the contralateral lung), the use of glucocorticoids for \> 14 days for the treatment of toxicity secondary to durvalumab (MEDI4736), hospitalization due to toxicity from durvalumab (MEDI4736), disease recurrence, or death due to any cause. Will be estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley. Hazard ratios (HRs) and corresponding 90% confidence intervals (CI) will be estimated using a Cox proportional hazards model with treatment arm as a single covariate. EFS will be compared between treatment arms using log-rank test, stratified on the randomization stratification factors., From date of randomization to date of first occurrence of EFS event, assessed up to 10 years|Overall survival (OS), Will be estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley. HRs and corresponding 90% CI will be estimated using a Cox proportional hazards model with treatment arm as a single covariate. OS will be compared between treatment arms using log-rank test, stratified on the randomization stratification factors., From date of randomization to date of death due to any cause, assessed up to 10 years|Incidence of adverse events, Will be evaluated using the Common Terminology Criteria for Adverse Events version 5 items. Binary proportions and associated confidence intervals will be calculated., Up to 10 years
Other Outcome Measures: Patient reported outcomes, Will be assessed by Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) instrument(s). For each of the PRO-CTCAE adverse events examined, the scores for each attribute (frequency, severity and/or interference) will be presented descriptively using summary statistics at each assessment time. Additionally, the worst severity and/or interference over the entire course will be summarized., Up to 10 years|Estimates of the primary outcome treatment effect, The hazard ratio of DFS and the corresponding 95% CIs will be estimated for subgroups defined by sex, race and ethnicity, respectively., Up to 10 years