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Pembrolizumab Combination Therapy for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Has a histologically- or cytologically-confirmed diagnosis of Stage IV squamous or non-squamous NSCLC

Has non-squamous NSCLC and is not eligible for an approved targeted therapy

Must not have

Has a known history of Hepatitis B or known active Hepatitis C virus infection

Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 27 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at the efficacy and safety of two different drugs in combination with pembrolizumab for people with NSCLC who have been treated with anti-PD-L1 therapy before.

Who is the study for?

This trial is for adults with Stage IV NSCLC who have already tried anti-PD-L1 therapy and chemotherapy but their cancer has gotten worse. They must have good organ function, be able to provide a tumor tissue sample, not be pregnant or breastfeeding, agree to use contraception, and not have severe immune reactions from previous immunotherapies.

What is being tested?

The study tests the safety and effectiveness of pembrolizumab combined with other investigational drugs (boserolimab, MK-4830, MK-0482) in patients whose lung cancer has progressed after treatment with anti-PD-L1 therapy. It's part of a larger research project exploring different pembrolizumab combinations.

What are the potential side effects?

Possible side effects include allergic reactions to the medications used (like pembrolizumab), issues related to the immune system attacking normal cells in the body which can affect various organs, fatigue, fever or chills due to infusion reactions and potential liver problems.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is confirmed to be at stage IV.

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My lung cancer is non-squamous and I can't have targeted therapy.

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My cancer has worsened despite treatment with a specific immune therapy.

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My cancer has worsened despite having platinum-based chemotherapy.

Exclusion Criteria

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

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I have a history of Hepatitis B or active Hepatitis C.

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I stopped immunotherapy due to a severe side effect.

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I have an autoimmune disease treated with medication in the last 2 years.

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I have serious heart problems, such as recent heart attacks or severe heart failure.

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I am currently being treated for an infection.

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I have been diagnosed with HIV.

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I have received an organ or tissue transplant from another person.

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I have had or currently have lung inflammation treated with steroids.

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I have been diagnosed with small cell lung cancer.

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I have cancer that has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 27 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

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Secondary study objectives

Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

Number of Participants Who Experience One or More Adverse Events (AEs)

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

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

Group I: Pembrolizumab + MK-4830Experimental Treatment2 Interventions

On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS MK-4830 IV for a maximum of 35 cycles (approximately 2 years).

Group II: Pembrolizumab + MK-0482Experimental Treatment2 Interventions

On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS MK-0482 IV for a maximum of 35 cycles (approximately 2 years).

Group III: Boserolimab + PembrolizumabExperimental Treatment4 Interventions

On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS boserolimab IV for a maximum of 35 cycles (approximately 2 years). All participants are premedicated 1.5 hours (±30 minutes) before infusion of boserolimab with 50 mg oral (PO) diphenhydramine (or equivalent dose of antihistamine) and 500-1000 mg of acetaminophen PO (or equivalent dose of analgesic).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Boserolimab

2018

Completed Phase 1

~190