Insight (S2414) for Early Stage NSCLC (Non-Small Cell Lung Cancer)

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
For more information, contact the study team at nick.jeffries@duke.edu.

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.
We will keep in touch with you for up to 10 years to see how you are doing.

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
ClinicalTrials.gov