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Checkpoint Inhibitor
Triple Drug Therapy for Non-Small Cell Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Jhanelle E. Gray, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older on day of signing informed consent.
Have archival tissue where available.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is testing a combination of three drugs to treat non-small cell lung cancer. Researchers want to know if it is effective and safe.
Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) who are treatment-naive or have had prior immunotherapy can join this trial. They should have a measurable tumor, be in good physical condition (ECOG score 0-1), and expect to live at least another 3-6 months. Women must not be pregnant and participants must agree to use contraception.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of combining three drugs: Nivolumab, Ipilimumab, and Nintedanib for NSCLC treatment. It's structured in phases to first determine safe dosages (Phase I) then assess how well the drug combination works (Phase II).See study design
What are the potential side effects?
Possible side effects include immune-related reactions that could affect organs, skin rashes, hormone gland problems like thyroid issues, liver inflammation, digestive tract symptoms such as diarrhea or colitis, fatigue, respiratory conditions like pneumonitis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have tissue samples from previous biopsies or surgeries.
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I am fully active or can carry out light work.
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My lung cancer is advanced, cannot be cured, and has a main type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 - Maximum Tolerated Dose (MTD)
Phase 2 - Objective Response Rate (ORR) per Treatment Arm
Secondary outcome measures
Phase 2: Disease Control Rate (DCR)
Phase 2: Overall Survival (OS)
Phase 2: Progression-free Survival (PFS)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Phase 1 - Dose EscalationExperimental Treatment3 Interventions
Nivolumab + Ipilimumab + Nintedanib dose escalation.
Nivolumab: 3 mg/kg IV Q2 weeks.
Ipilimumab: 1 mg/kg Q6 weeks.
Nintedanib Level -1: 100 mg by mouth (PO) once a day (QD) Days 1-14 (Daily dose =100 mg).
Nintedanib Level 0:150 mg by mouth (PO) once a day (QD) Days 1-14 (Daily dose =150 mg)
Nintedanib Level 1: 100 mg PO twice daily (BID) Days 2-28 (Daily dose = 200 mg).
Nintedanib Level 2: 150 mg PO BID Days 1-14 (Daily dose = 300 mg).
Nintedanib Level 3: 200 mg PO BID Days 1-14 (Daily dose = 400 mg).
Group II: Phase 2 - Arm AActive Control3 Interventions
Arm A: Newly diagnosed or treatment-naïve patients, with a target overall response rate (ORR) of 50%.
Nivolumab + Ipilimumab + Nintedanib at RP2D.
Group III: Phase 2 - Arm BActive Control3 Interventions
Arm B: Patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%.
Nivolumab + Ipilimumab + Nintedanib at RP2D.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Nintedanib
2015
Completed Phase 4
~3680
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,424 Total Patients Enrolled
Jhanelle E. Gray, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have stomach or intestine problems that affect medication absorption.I do not have any serious illnesses or conditions that could make this study unsafe for me.You have at least one visible tumor that can be measured using specific criteria.I am not currently using any other cancer treatments not listed in the study.I haven't had radiotherapy (except for brain, extremities, or stereotactic) in the last 2 weeks.I've had severe side effects from previous immunotherapy.I am on blood thinners that need regular INR checks, except for low-dose treatments.I haven't had radiation on the cancer area in the last 3 months unless it's gotten worse.Women who are pregnant or breastfeeding must have a negative pregnancy test before starting the study treatment.I have had active tuberculosis in the past.I am 18 years old or older.You have a history of an ongoing immune system problem since birth.I have not had any serious bleeding or blood clot events in the last 6 months.You have an active Hepatitis B or Hepatitis C infection.My organs and bone marrow are functioning well.I have tissue samples from previous biopsies or surgeries.I am willing to provide a new or archived tissue sample for the study.I have not used experimental drugs or participated in another clinical trial with non-FDA approved medication in the last 4 weeks.I haven't had another type of cancer in the last 2 years.I have not received a live vaccine within the last 30 days.I have lost more than 20% of my body weight in the last 6 months.I haven't had chemotherapy, immunotherapy, or targeted cancer therapy in the last 2 weeks.I do not have active or untreated brain metastases and am not on high doses of steroids.I haven't used strong immune-suppressing drugs recently, except for small doses or certain types.I have not had an autoimmune disease in the last 2 years, except for vitiligo, Grave's disease, type I diabetes, or psoriasis not needing systemic treatment.My tumor is in a central location and is invading major blood vessels.I have NSCLC, was treated with immunotherapy, and my cancer either didn't improve or got worse.I do not have serious heart conditions like uncontrolled high blood pressure, recent heart attacks, severe heart failure, or dangerous irregular heartbeats.I have a history of or currently have non-infectious lung inflammation.I haven't had major surgery or injuries in the last 4 weeks, and I don't plan any surgery during the study.I do not have any serious infections requiring antibiotics.I have NSCLC and may or may not have received prior treatments, but if my cancer returned, it was more than 6 months after treatment.I am newly diagnosed with NSCLC and have not received treatment, or my cancer returned more than 6 months after treatment.You are currently abusing alcohol or drugs.I have had cancer spread to the lining of my brain and spinal cord.I have received an organ from another person.I am fully active or can carry out light work.Women who can have children must have a negative pregnancy test before starting the study. If the urine test is positive or unclear, a blood test will be needed.I have previously been treated with nintedanib.I have side effects from past cancer treatment that are not severe.I have a genetic condition that affects my blood's ability to clot.Things like family, where you live, or how you feel might make it hard for you to follow the study's plan and schedule.I am not allergic to nintedanib, nivolumab, ipilimumab, peanuts, soy, or related drug ingredients.Your blood clotting test results are significantly different from the normal range.Your heart's electrical activity (QTcB) needs to be less than 470 milliseconds if you're male, and less than 480 milliseconds if you're female.My lung cancer is advanced, cannot be cured, and has a main type.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 - Arm A
- Group 2: Phase 2 - Arm B
- Group 3: Phase 1 - Dose Escalation
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what circumstances is Nivolumab typically prescribed?
"Nivolumab is commonly used to treat malignant melanoma which cannot be surgically removed, as well as squamous cell carcinomas, recurrent events and other illnesses."
Answered by AI
Are there still places open to participants in this experiment?
"Unfortunately, this research project is not in need of any additional participants at the moment. Initially posted on February 2nd 2018 and last updated November 22nd 2022, it has since been concluded. However, there are many alternative clinical trials for lung cancer (2046) and Nivolumab (782), both of which are actively recruiting patients."
Answered by AI
What is the scope of participation in this clinical experiment?
"Unfortunately, this study is no longer accepting applications. It was first listed on February 2nd 2018 and its most recent update occurred on November 22nd 2022. Those interested in alternative trials may wish to refer to the 2046 studies involving lung cancer or 782 clinical trials researching Nivolumab's efficacy."
Answered by AI
What supplementary research has been completed on Nivolumab?
"Currently, 91 Phase 3 trials are underway to investigate the efficacy of Nivolumab. Despite Pittsburgh, Pennsylvania being a hub for such research, there are 43007 sites participating in these studies across the world."
Answered by AI
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