Purpose of this Study
We are doing this study to compare 2 different approaches for patients who have surgery to remove non-small cell lung cancer (NSCLC). We want to see if giving patients an immunotherapy drug called durvalumab (the study drug) after surgery has different outcomes than the usual approach, which is to closely monitor a patient's condition for any changes.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with stage II-IIIB NSCLC
- Have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the NCCN Guidelines) no more than 12 weeks before getting a study group assignment
- Have had a pathologic complete response to surgery (no viable tumor in the resected specimen or lymph nodes)
- Do not have any EGFR mutations or ALK gene fusion
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- Group 1: If you are in this group, you will get the study drug. You will get the study drug as an infusion (through a vein in your arm) every 28 days. Each infusion will take about 60 minutes. You will get up to 12 doses of the study drug.
- Group 2: If you are in this group, you will receive the usual approach to care after surgery (observation). Your doctor will watch your condition carefully and look for any signs of the cancer returning. You will not receive further treatment unless new signs or symptoms appear.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
S2414, A Randomized Phase III Trial Incorporating Pathologic Complete Response in Participants with Early Stage Non-Small Cell Lung Cancer to Optimize Immunotherapy in the Adjuvant Setting (INSIGHT) (NCT06498635)
Principal Investigator
Joel
Rivera concepcion
Protocol Number
PRO00118347
NCT ID
NCT06498635
Phase
III
Enrollment Status
Open to Enrollment