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.
Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)
Participants must have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the National Comprehensive Cancer Network [NCCN] guidelines) within 84 days (12 weeks) prior to randomization. Acceptable types of surgical resection are: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy. Wedge resection is not allowed.
Note the NCCN guidelines: N1 and N2 node resection and mapping is a routine component of lung cancer resections. It is recommended at a minimum one N1 and three N2 stations is sampled or complete lymph node dissection. Formal ipsilateral mediastinal lymph node dissection is indicated for participants undergoing resection for N2 disease
Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review
None
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Durvalumab
Biological/VaccineGiven IV
Patient Observation
Other interventionUndergo active surveillance
Questionnaire Administration
Other interventionAncillary studies
Disease-free survival (DFS)
Will be assessed using a 1-sided 5% level log-rank test accounting for interim testing, stratified on the randomization stratification factors.
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.
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.
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.
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.
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.
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