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Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
NCT06498635 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Durvalumab
- OTHER Questionnaire Administration
- OTHER Patient Observation
Study Locations (20)
California
- Tower Cancer Research Foundation — Beverly Hills
- Veterans Affairs Loma Linda Healthcare System — Loma Linda
- Cedars Sinai Medical Center — Los Angeles
- University of California Davis Comprehensive Cancer Center — Sacramento
- Torrance Memorial Physician Network - Cancer Care — Torrance
Connecticut
- Hartford HealthCare - Avon — Avon
- Hartford Hospital — Hartford
- Hartford HealthCare - Manchester — Manchester
- Midstate Medical Center — Meriden
- The Hospital of Central Connecticut — New Britain
Delaware
- Beebe South Coastal Health Campus — Millville
- Helen F Graham Cancer Center — Newark
- Medical Oncology Hematology Consultants PA — Newark
- Beebe Health Campus — Rehoboth Beach
Florida
- Moffitt Cancer Center-International Plaza — Tampa
- Moffitt Cancer Center - McKinley Campus — Tampa
- Moffitt Cancer Center — Tampa
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro
Colorado
- Saint Mary's Hospital and Regional Medical Center — Grand Junction
Georgia
- Emory University Hospital Midtown — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2039-07-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06498635
The ClinicalTrials.gov registry entry for NCT06498635 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 306 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06498635 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Connecticut, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06498635 about?
NCT06498635 is a clinical study titled "Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial". 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 int...
What is the current status of trial NCT06498635?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 306 participants. The study started on 2025-04-01. Estimated completion is 2039-07-15.
What conditions does trial NCT06498635 study?
This clinical trial studies the following conditions: Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06498635?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Durvalumab (BIOLOGICAL), Questionnaire Administration (OTHER), Patient Observation (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06498635?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06498635 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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