OncoMatch/Clinical Trials/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
Is NCT06498635 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Durvalumab for lung non-small cell carcinoma.
Treatment: Durvalumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Required: EGFR wild-type
Disease stage
Required: Stage II, IIIA, IIIB
Performance status
ZUBROD 0–2
Prior therapy
Must have received: platinum-based chemotherapy — neoadjuvant
Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy
Must have received: anti-PD-1 therapy — neoadjuvant
Participants must have received...anti-PD-1 or anti-PD-L1 therapy
Cannot have received: systemic therapy
Exception: neoadjuvant platinum-based chemotherapy and anti-PD-1/PD-L1 therapy
Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization
Cannot have received: post-operative radiation therapy
Participants must not have received post-operative radiation therapy (PORT) for NSCLC
Cannot have received: concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy
Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study
Lab requirements
Blood counts
Hemoglobin > 9.0 g/dL; Absolute neutrophil count ≥ 1.5 x 10^3/uL; Platelets ≥ 100 x 10^3/uL
Kidney function
calculated creatinine clearance ≥ 40 mL/min
Liver function
Total bilirubin ≤ 1 x institutional ULN unless history of Gilbert's disease (then ≤ 5 x ULN); AST/ALT ≤ 3 × institutional ULN
Hemoglobin > 9.0 g/dL...Absolute neutrophil count ≥ 1.5 x 10^3/uL...Platelets ≥ 100 x 10^3/uL...Total bilirubin ≤ 1 x institutional ULN unless history of Gilbert's disease...AST/ALT ≤ 3 × institutional ULN...calculated creatinine clearance ≥ 40 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro · Jonesboro, Arkansas
- Tower Cancer Research Foundation · Beverly Hills, California
- Veterans Affairs Loma Linda Healthcare System · Loma Linda, California
- Cedars Sinai Medical Center · Los Angeles, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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