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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
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 belowSelect...
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:Select...
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
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 moreTrial 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
Ipilimumab
2014
Completed Phase 3
~3140
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,640 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,200 Total Patients Enrolled
Adrian Sacher, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not incarcerated and can consent and follow study procedures.I haven't taken immunosuppressive drugs in the last 14 days, with some exceptions.I have not had any treatment for my current lung cancer diagnosis.I've had to stop IV drug treatments more than once due to bad reactions.I haven't had cancer treatment or palliative radiotherapy in the last 3 weeks.I have previously received immunotherapy.I have had an autoimmune disorder in the last 3 years.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 lung cancer has returned or spread to other parts.My lung cancer can be of any type.My surgery did not remove all of my cancer.My tumor's PDL1 level is below 50%.I haven't had a heart attack, stroke, or severe heart failure in the last 3 months.My cancer does not have mutations like EGFR, ALK, or ROS1.I have a history of immune system issues, organ transplant, or active tuberculosis.I have not had any other cancer besides non-invasive types in the last 2 years.You have HIV, chronic or active hepatitis B or C, or active hepatitis A.I haven't had a live vaccine or major surgery in the last 30 days.You are expected to live for at least 12 more weeks.I weigh at least 35 kilograms.I am fully active or can carry out light work.I am not pregnant, breastfeeding, nor plan to become pregnant during the study.My organs and bone marrow are working well.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Non-Small cell Lung Cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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