Durvalumab After Surgery for Early-Stage Lung Cancer

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 Phase 3 Interventional Study
Lung Non-Small Cell Carcinoma Stage II Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
306 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for patients who have had surgery for early-stage non-small cell lung cancer and show no signs of cancer remaining. Participants will receive a treatment called durvalumab to see if it helps prevent the cancer from coming back instead of just being watched closely by their doctor.

Are You a Good Fit for This Trial?
Rules you out Chronic hepatitis BHIV infectionHepatitis C

You may be able to join if

  • I have been diagnosed with stage II to IIIA non-small cell lung cancer.
  • I have had complete surgery for my lung cancer within the last 12 weeks.
  • I have no remaining cancer cells in my body after surgery.
  • I have had at least two cycles of certain chemotherapy before surgery.
  • I am at least 18 years old.
  • I weigh more than 30 kg.
  • I have my doctor’s approval that I have recovered from previous surgery.
  • I have certain blood test results within required limits.

You may not be able to join if

  • I have known EGFR mutations or ALK gene fusion.
  • I have active autoimmune disease that required treatment in the last 2 years.
  • I have not recovered from certain side effects from previous cancer treatment.
  • I have received any cancer treatment within the last 28 days.
  • I have had post-operative radiation therapy for my lung cancer.
  • I am pregnant or nursing.
  • I have an organ transplant.
  • I have a previous or current cancer that affects the safety of this trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This 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 interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are n…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 define…
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