A081801 (Lung Cancer)

Purpose of this Study

We are doing this study to see if combining immunotherapy with chemotherapy is a better treatment than chemotherapy alone for NSCLC.

Who Can Participate?

Eligibility

Adults 18 and older who:
  • Have lung cancer that has been removed while on Duke Cancer Study A151216
  • Had their surgery between 33-77 days ago
  • Are negative for the genetic markers EGRF and ALK

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 (fair, equal chance) to 1 of 3 groups:
  • One group will receive only chemotherapy for 3 months
  • Another group will receive chemotherapy for 3 months followed by immunotherapy for up to 1 year
  • A third group will receive chemotherapy and immunotherapy together for 3 months followed by immunotherapy for up to 10 months
  • Regardless of group assignment, all study participants will:
    • Get check-ups from your doctor every 3 months for the first 2 years after treatment
    • Get check-ups from your doctor every 6 months for the 3rd, 4th, and 5th years after treatment
    • Get a yearly check-up from your doctor for 5 more years once you hit the 5-year mark after treatment
    Altogether, you will continue to see your doctor and study team for 10 years after treatment.

    Locations

    Duke University Hospital
    Duke Raleigh Hospital
    Other

    Visit Timing

    Weekdays

    Compensation

    No

    Spanish Materials Available

    Yes

    Study Details

    Full Title

    Alliance A081801: Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST CHEMO-IO

    Principal Investigator

    Jeffrey
    Crawford

    Protocol Number

    PRO00106593

    NCT ID

    NCT04267848

    Phase

    III

    Enrollment Status

    Open to Enrollment