Computed Tomography / Lung Non Small Cell Carcinoma / Stage IIIA Lung Cancer AJCC V8 · Phase 3 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized trial registration (INSIGHT, NCT06498635) comparing adjuvant durvalumab to standard observation in patients with stage II–IIIB NSCLC after complete resection. The trial is actively recruiting and no outcome data are yet posted; results will determine whether post-surgical immunotherapy improves disease-free survival compared to surveillance alone.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8; age from 18 Years. Intervention: Arm I (durvalumab). Compared with: Arm II (active surveillance) — Active Comparator. n = 306. 273 sites: United States.
This is a Phase 3 randomized trial registration (INSIGHT, NCT06498635) comparing adjuvant durvalumab to standard observation in patients with stage II–IIIB NSCLC after complete resection. The trial is actively recruiting and no outcome data are yet posted; results will determine whether post-surgical immunotherapy improves disease-free survival compared to surveillance alone.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This trial will determine whether adjuvant durvalumab extends disease-free survival in early-stage NSCLC after complete resection, compared to observation. Results could inform post-operative immunotherapy practice if a significant benefit is demonstrated.
This is a Phase 3 RCT registration with no results posted; the trial is actively recruiting and designed to compare durvalumab against observation in early-stage NSCLC after surgery, but outcome data are not yet available.
As stated by the source record.
Quoted from the source exactly as published.
This trial will determine whether adjuvant durvalumab extends disease-free survival in early-stage NSCLC after complete resection, compared to observation. Results could inform post-operative immunotherapy practice if a significant benefit is demonstrated.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06498635). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 306 participants (ESTIMATED). 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. Primary outcome measures: Disease-free survival (DFS) , 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. Brief 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.
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