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NCT06498635 · ClinicalTrials.gov record · last posted 2026-08-21

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

StatusRecruiting
PhasePhase 3
Started2025-04-01
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 6 changes detected by DataLookout

2026-08-22
minor
Trial sites expanded: 275 → 278 locations
2026-07-31
minor
Trial sites expanded: 266 → 271 locations
2026-06-23
minor
Trial sites expanded: 245 → 263 locations
2026-06-04
minor
Trial sites expanded: 233 → 243 locations
2026-05-28
minor
Trial sites expanded: 230 → 233 locations
2026-04-02
minor
Trial sites expanded: 221 → 225 locations
Trial Details
NCT Number NCT06498635
Lead Sponsor National Cancer Institute (NCI)
Conditions Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8
Enrollment 306 participants
Start Date 2025-04-01
Primary Completion 2039-07-15 (estimated)
Study Completion 2039-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-21