OncRef

Clinical Trial: NCT06498635

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

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-19

Study Overview

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.

Official Title

Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting (INSIGHT)

Conditions

Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8

Intervention / Treatment

  • Procedure: Biospecimen Collection
  • Procedure: Computed Tomography
  • Biological: Durvalumab
  • Other: Patient Observation
  • Other: Questionnaire Administration

Other Study ID Numbers

  • NCI-2024-05588
  • NCI-2024-05588
  • S2414
  • S2414
  • U10CA180888

Start Date (Actual)

2025-04-01

Primary Completion Date (Estimated)

2039-07-15

Study Completion Date (Estimated)

2039-07-15

Enrollment (Estimated)

306

Study Type

Interventional

Phase

Phase 3