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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Lung Cancer (ATLAS Trial)

Phase 2

Waitlist Available

Led By Adrian Sacher, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior radiation, surgery or chemotherapy is allowed for the current diagnosis of non-small cell lung cancer

Recurrent or newly diagnosed metastatic non-small cell lung cancer

Must not have

Participants who are involuntarily incarcerated or are unable to willingly provide consent or are unable to comply with the protocol procedures

History of more than one event of infusion related reactions requiring permanent discontinuation of intravenous drug treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effectiveness of two drugs, nivolumab and ipilimumab, for treating non-small cell lung cancer that has metastasized.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Nivolumab and Ipilimumab may cause immune system-related side effects such as inflammation in various body parts (like lungs or intestines), skin rashes, hormone gland problems (like thyroid), liver inflammation, infusion reactions (during drug administration), fatigue, weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My lung cancer has returned or spread to other parts.

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My tumor's PDL1 level is below 50%.

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

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I weigh at least 35 kilograms.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have previously received immunotherapy.

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

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

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My surgery did not remove all of my cancer.

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants whose disease does not worsen (progression-free survival rate) at 6 months

Secondary study objectives

Average percentage of tumor cfDNA detected in the blood (tumor cfDNA clearance rate) at 12 weeks

Cell-Free DNA

Average time from the date of study enrolment until death (overall survival)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platinum-based Chemotherapy

2017

Completed Early Phase 1

~570

Nivolumab

2014

Completed Phase 3

~5220