Nivolumab + Ipilimumab for Lung Cancer (ATLAS Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByAdrian G. Sacher

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 8 jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this research study is to look at how effective two drugs, nivolumab and ipilimumab, are for people with non-small lung cancer that has metastasized (has spread to other parts of the body) and to see what effects these drugs have on these tumors.

Eligibility Criteria

Adults with metastatic non-small cell lung cancer, weighing at least 35 kg and expected to live more than 12 weeks. They must not have had prior treatments for this diagnosis or certain other cancers in the last two years, no major organ transplants, active infections like HIV or hepatitis, and no recent heart issues. Participants need functioning organs/marrow and cannot be on immunosuppressants.

Inclusion Criteria

I have not had any treatment for my current lung cancer diagnosis.

My lung cancer has returned or spread to other parts.

My tumor's PDL1 level is below 50%.

My cancer does not have mutations like EGFR, ALK, or ROS1.

I weigh at least 35 kilograms.

I am fully active or can carry out light work.

Exclusion Criteria

I am not incarcerated and can consent and follow study procedures.

I've had to stop IV drug treatments more than once due to bad reactions.

I have previously received immunotherapy.

All my side effects from previous treatments, except for hair loss, have gone back to normal.

I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

My surgery did not remove all of my cancer.

I haven't had a heart attack, stroke, or severe heart failure in the last 3 months.

I haven't had a live vaccine or major surgery in the last 30 days.

I am not pregnant, breastfeeding, nor plan to become pregnant during the study.

Participant Groups

The trial is testing the effectiveness of nivolumab and ipilimumab drugs on metastatic non-small cell lung cancer. It also examines how a cfDNA blood test can help track tumor changes during treatment. Patients will not have received previous surgery, radiation, or chemotherapy for their current cancer diagnosis.

1Treatment groups

Experimental Treatment

Group I: Non-Small cell Lung CancerExperimental Treatment4 Interventions

Nivolumab, intravenously (given by vein), once every 3 weeks Ipilimumab, intravenously (given by vein), once every 6 weeks Participants will have blood samples taken for cell free deoxyribonucleic acid (cfDNA) testing. If there is an increasing or stable tumor cfDNA, platinum-doublet chemotherapy will be given.

Ipilimumab, Nivolumab is already approved in United States, United States, European Union, European Union, Canada, Canada, Japan, Japan for the following indications:

🇺🇸 Approved in United States as Yervoy for: