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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.

Must not have

Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug

Concurrent use of other anticancer agents including chemotherapy, targeted therapy, radiotherapy or immunotherapy not otherwise specified in the protocol.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

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.

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).

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 below

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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.

Exclusion Criteria

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

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I do not have stomach or intestine problems that affect medication absorption.

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I am not currently using any other cancer treatments not listed in the study.

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I haven't had radiotherapy (except for brain, extremities, or stereotactic) in the last 2 weeks.

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I've had severe side effects from previous immunotherapy.

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I have had active tuberculosis in the past.

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I have not had any serious bleeding or blood clot events in the last 6 months.

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I have not used experimental drugs or participated in another clinical trial with non-FDA approved medication in the last 4 weeks.

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I have not received a live vaccine within the last 30 days.

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I have lost more than 20% of my body weight in the last 6 months.

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I have a history of or currently have non-infectious lung inflammation.

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I haven't had major surgery or injuries in the last 4 weeks, and I don't plan any surgery during the study.

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I do not have serious heart conditions like uncontrolled high blood pressure, recent heart attacks, severe heart failure, or dangerous irregular heartbeats.

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I do not have any serious infections requiring antibiotics.

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My tumor is in a central location and is invading major blood vessels.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have received an organ from another person.

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I have previously been treated with nintedanib.

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I have a genetic condition that affects my blood's ability to clot.

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I am not allergic to nintedanib, nivolumab, ipilimumab, peanuts, soy, or related drug ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1 - Maximum Tolerated Dose (MTD)

Phase 2 - Objective Response Rate (ORR) per Treatment Arm

Secondary study objectives

Phase 2: Disease Control Rate (DCR)

Phase 2: Overall Survival (OS)

Phase 2: Progression-free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

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

2015

Completed Phase 3

~4010

Ipilimumab

2015

Completed Phase 3

~3420