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
- 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?
If you choose to join this study, you will:
- Be randomly assigned (like a coin flip) to 1 of 3 treatment 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
- 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.
- Be randomly assigned (like a coin flip) to 1 of 3 treatment 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
- 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 ACCRUAL