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Checkpoint Inhibitor
Immunotherapy + Local Consolidation Therapy for Lung Cancer
Phase 3
Recruiting
Led By John V Heymach
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 50 mL (if using the Cockcroft-Gault formula) (obtained within 14 days prior to randomization/registration)
Stage IV (according to the American Joint Committee on Cancer [AJCC] 8th edition) measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Must not have
Patients excluded with any prior treatment of pneumonitis requiring corticosteroids within 60 days prior to the first dose of nivolumab
Systemic immunotherapy for metastatic NSCLC. Immunotherapy agents include, but are not limited to, agents targeting the PD1/PD-L1 axis (e.g. nivolumab, pembrolizumab, atezolizumab, durvalumab) or CTLA-4 (ipilimumab, tremelimumab) pathways.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after completion of study treatment
Awards & highlights
Summary
This trial is testing whether adding immunotherapy to standard local consolidation therapy can improve outcomes for patients with stage IV non-small cell lung cancer.
Who is the study for?
This trial is for adults with stage IV non-small cell lung cancer. Eligible participants must have measurable disease, adequate organ function, and no prior immunotherapy for metastatic NSCLC. Women of childbearing potential must test negative for pregnancy and use contraception, as should men if their partners are of childbearing potential. Patients with treated brain metastases may qualify if stable.Check my eligibility
What is being tested?
The study is testing the effectiveness of nivolumab and ipilimumab (immunotherapy drugs) with or without local consolidation therapy (surgery or radiation) in treating advanced lung cancer. The goal is to see if adding local treatments to immunotherapy improves outcomes compared to immunotherapy alone.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, fatigue, skin issues, hormone gland problems like thyroid disorders, infusion reactions during drug administration, and possible increased risk of infections due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function tests are within the normal range.
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My cancer is stage IV and can be measured for changes.
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I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken steroids for pneumonitis in the last 60 days.
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I am receiving immunotherapy for advanced lung cancer.
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I do not have hepatitis B or C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year after completion of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after completion of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
OS in oligometastatic subgroup
Overall survival (OS) in overall population
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (ipilimumab, nivolumab, LCT)Experimental Treatment6 Interventions
INDUCTION PHASE: Patients receive nivolumab IV over 90 minutes on days 1, 15, and 29, and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients receive LCT consisting of surgery and/or radiation 14 days after completion of Induction Phase. Patients then receive nivolumab and ipilimumab as in arm A beginning within 4 weeks after LCT. Courses repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (ipilimumab, nivolumab)Experimental Treatment3 Interventions
INDUCTION PHASE: Patients receive nivolumab IV over 90 minutes on days 1, 15, and 29, and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Patients receive nivolumab IV over 60 minutes on days 1, 15, and 29 and ipilimumab IV over 90 minutes on day 1. Courses repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Ipilimumab
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4740
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,793,879 Total Patients Enrolled
John V HeymachPrincipal InvestigatorM.D. Anderson Cancer Center
John V Heymach, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer does not have common EGFR or ALK mutations, or if it does, there's no standard treatment for them.I do not have an active autoimmune disease, except for allowed conditions like vitiligo or type I diabetes.Things like family, emotions, where you live, or other social factors may make it hard for you to follow the study plan and schedule.I haven't taken steroids for pneumonitis in the last 60 days.I haven't had cancer treatment in the last 3 weeks, except hormone therapy or contraceptives.I am receiving immunotherapy for advanced lung cancer.My lung cancer is confirmed and not small cell or carcinoid type.I am a man, sexually active with a woman capable of bearing children, and will use effective contraception.I have had cancer in the past 2 years, but it was a type that could be cured with local treatment.I am not on high-dose steroids or strong immune system medications.I am aware of the liver risks with my cancer treatment and will be cautious with certain medications.Your liver function test results should be within a certain range before you can join the study.My brain metastases are treated, I'm neurologically stable, and not on high steroids.I may have had radiation for cancer spread but still have at least one untreated spot.I have signed and understand the consent form according to the study's rules.I've had one round of treatment for my cancer after it spread, including drugs to stop new blood vessels from forming.My kidney function tests are within the normal range.I am using or willing to use birth control as required if I can have children.My cancer is stage IV and can be measured for changes.Your hemoglobin level is higher than 9.0 grams per deciliter within the 14 days before starting the study.Your blood platelet count is at least 100,000 per microliter.Your white blood cell count is lower than 2000 cells per microliter.You have had a strong allergic reaction to any monoclonal antibody in the past.Your neutrophil count is at least 1500 per microliter within 14 days before starting the study.I do not have hepatitis B or C.I have taken a pregnancy test within the last 48 hours and it was negative.You are required by law to stay in a hospital for treatment of a mental illness or infectious disease.I am fully active or restricted in physically strenuous activity but can do light work.Your bilirubin level needs to be within a certain range, but if you have Gilbert syndrome, it can be a little higher.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (ipilimumab, nivolumab, LCT)
- Group 2: Arm A (ipilimumab, nivolumab)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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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