Nivolumab for Non-Small Cell Lung Cancer
(ANVIL Trial)
Recruiting at 1013 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial studies how well nivolumab works in treating patients with non-small cell lung cancer. Nivolumab is an immunotherapy drug that helps the immune system attack cancer cells. The goal is to see if it can prevent the cancer from coming back. Nivolumab has shown efficacy in treating various malignancies, including non-small cell lung cancer.
Research Team
JE
Jamie E Chaft
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
Adults who've had surgery for stage IB-IIIA non-small cell lung cancer and are done with any chemotherapy. They must not be pregnant, breastfeeding, or have certain viral infections. Their liver and kidney functions should be normal, they can't have autoimmune diseases except some like type I diabetes or controlled hypothyroidism, and no prior immune checkpoint inhibitor treatments.Inclusion Criteria
I've had a chest CT scan within the last month showing no signs of disease spread.
I am fully active or can carry out light work.
You have not had allergic reactions to drugs similar to nivolumab.
See 34 more
Treatment Details
Interventions
- Nivolumab (Monoclonal Antibodies)
Trial OverviewThe trial is testing if nivolumab (an immunotherapy drug) given after surgery and chemotherapy can help treat non-small cell lung cancer by boosting the body's immune response to attack cancer cells. It involves monitoring through scans like CT and PET, blood tests, and collecting biospecimens.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (nivolumab)Experimental Treatment5 Interventions
Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT throughout the trial and blood sample collection during screening and follow-up. Patients may undergo an ECHO as clinically indicated on study.
Group II: Arm II (observation)Active Control5 Interventions
Patients are followed serially with CT and/or PET/CT imaging for up to 1 year and then during follow-up. Patients also undergo blood sample collection during screening and follow-up. Patients may undergo an ECHO as clinically indicated on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Trials
14,080
Recruited
41,180,000+