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

Recruiting now · Phase 3

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

In brief

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.

Key facts

Study ID

NCT06498635

Run by

National Cancer Institute (NCI)

People needed

306

Starts

2025-04-01

Expected to finish

2039-07-15

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Participants must have a PD-L1 status result (e.g. [< 1% versus >= 1% or unknown])
• Participants must not have known EGFR mutations, or ALK gene fusion
• Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines
• 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
• Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization
• Participants must not have medical contraindications or severe adverse events to receiving anti-PD-1 or anti-PD-L1 therapy
• Participants must not have received post-operative radiation therapy (PORT) for NSCLC
• Participants must not have any unresolved toxicity National Cancer Institute (NCI) CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo. Note, participants with grade ≥2 neuropathy may be included at the discretion of the treating investigator. Note, participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the discretion of the treating investigator
• Participant must be ≥ 18 years old at time of study entry
• Participants must have body weight > 30 kg
• Participant must have Zubrod performance status of 0-2
• Participant must have a complete medical history and physical exam within 28 days prior to randomization
• Hemoglobin > 9.0 g/dL (within 28 days prior to randomization)
• Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to randomization)
• Platelets ≥ 100 x 10\^3/uL (within 28 days prior to randomization)
• Total bilirubin ≤ 1 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to randomization)
• Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization)
• Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench https://txwb.crab.org/TXWB/Tools.aspx
• Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
• Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization
• Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated

Where it is running

• Tower Cancer Research Foundation — Beverly Hills, California, United States (enrolling)
• Kaiser Permanente Dublin — Dublin, California, United States (enrolling)
• Kaiser Permanente-Fremont — Fremont, California, United States (enrolling)
• Kaiser Permanente Fresno Orchard Plaza — Fresno, California, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Veterans Affairs Loma Linda Healthcare System — Loma Linda, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Kaiser Permanente- Modesto MOB II — Modesto, California, United States (enrolling)
• Kaiser Permanente-Oakland — Oakland, California, United States (enrolling)
• Kaiser Permanente-Roseville — Roseville, California, United States (enrolling)
• Kaiser Permanente Downtown Commons — Sacramento, California, United States (enrolling)
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Kaiser Permanente-South Sacramento — Sacramento, California, United States (enrolling)
• Kaiser Permanente-San Francisco — San Francisco, California, United States (enrolling)
• Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States (enrolling)
• Kaiser Permanente San Leandro — San Leandro, California, United States (enrolling)
• Kaiser San Rafael-Gallinas — San Rafael, California, United States (enrolling)
• Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States (enrolling)
• Kaiser Permanente-Santa Rosa — Santa Rosa, California, United States (enrolling)
• Kaiser Permanente-South San Francisco — South San Francisco, California, United States (enrolling)
• Torrance Memorial Physician Network - Cancer Care — Torrance, California, United States (enrolling)
• Kaiser Permanente-Vallejo — Vallejo, California, United States (enrolling)
• Kaiser Permanente-Walnut Creek — Walnut Creek, California, United States (enrolling)
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States (enrolling)
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)

Full record on ClinicalTrials.gov

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