Immunotherapy After Surgery for Early-Stage Non-Small Cell Lung Cancer: INSIGHT Trial
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06498635
This study is exploring whether adding the immunotherapy drug durvalumab after surgery can help prevent early-stage non-small cell lung cancer from returning, compared to the usual approach of regular check-ups without additional treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
This phase III trial is testing if the immunotherapy drug durvalumab can help prevent cancer from coming back in patients with early-stage non-small cell lung cancer who have had surgery. Normally, after surgery, patients are closely monitored with regular doctor visits to check for cancer recurrence, but no further treatment is given unless the cancer returns. This study aims to find out if using durvalumab after surgery is more effective than just observation in helping patients live longer and keeping the cancer from coming back.
Description
The main goal of this study is to see if patients with stage II-IIIB non-small cell lung cancer who have no remaining cancer cells after standard treatment live longer without the cancer returning when given durvalumab compared to just being monitored.
Secondary goals include comparing overall survival rates, checking for any side effects from durvalumab, and seeing how long patients live without any cancer events. The study will also collect samples for future research and assess patients' quality of life during the trial.
Patients in the study are randomly assigned to one of two groups:
- Group 1: Receives durvalumab through an IV every 28 days for up to 12 cycles, as long as the cancer does not progress or side effects are manageable. Patients will have regular CT scans and blood tests.
- Group 2: Undergoes regular monitoring for 12 months with CT scans and blood tests, but does not receive additional treatment unless the cancer returns.
After the study treatment, patients will have annual follow-ups for up to 10 years.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of stage II-IIIB non-small cell lung cancer.
- Must have had surgery to completely remove the cancer within the last 12 weeks.
- Must have no remaining cancer cells in the removed tissue.
- Must have a PD-L1 status result.
- Must not have certain genetic mutations (EGFR or ALK).
- Must have received at least two cycles of specific chemotherapy and immunotherapy before surgery.
- Must not be planning to receive other cancer treatments during the study.
- Must not have had any cancer treatment in the last 28 days before joining the study.
- Must not have any medical reasons preventing the use of durvalumab.
- Must not have received radiation therapy after surgery.
- Must be 18 years or older and weigh more than 30 kg.
- Must have good overall health and specific blood test results.
- Must not have any unresolved severe side effects from previous cancer treatments.
- Must not have had an organ transplant or other cancers that could interfere with the study.
- Must not have any autoimmune diseases requiring treatment in the last two years.
- Must not be pregnant or breastfeeding and must agree to use effective contraception.
- Must not have received a live vaccine in the last 28 days.
- Must be willing to participate in specimen banking and complete quality of life questionnaires.
- Must provide informed consent to participate in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| Hartford Hospital | 06102 | Hartford | Connecticut |
| Midstate Medical Center | 06451 | Meriden | Connecticut |
| The Hospital of Central Connecticut | 06050 | New Britain | Connecticut |
| Kootenai Health - Coeur d'Alene | 83814 | Coeur d'Alene | Idaho |
| Kootenai Clinic Cancer Services - Post Falls | 83854 | Post Falls | Idaho |
| Kootenai Clinic Cancer Services - Sandpoint | 83864 | Sandpoint | Idaho |
| Mary Greeley Medical Center | 50010 | Ames | Iowa |
| McFarland Clinic - Ames | 50010 | Ames | Iowa |
| McFarland Clinic - Boone | 50036 | Boone | Iowa |
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