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:<ul>
<li>Have lung cancer that has been removed while on Duke Cancer Study A151216</li>
<li>Had their surgery between 33-77 days ago</li>
<li>Are negative for the genetic markers EGRF and ALK</li></ul>

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