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Pembrolizumab + Investigational Agents 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 not received prior systemic treatment for metastatic NSCLC

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

Must not have

Has a known history of Human Immunodeficiency Virus (HIV) infection

Has an active autoimmune disease that has required systemic treatment in the past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 27 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment and its side effects.

Who is the study for?

This trial is for adults with advanced Non-Small Cell Lung Cancer (NSCLC) that tests positive for PD-L1 and haven't had treatment before. They must have good organ function, agree to use contraception, and not be pregnant or breastfeeding. Excluded are those with certain infections, heart conditions, other cancers within 2 years, severe allergies to monoclonal antibodies, or prior treatments like chemotherapy.

What is being tested?

The study examines the effectiveness and safety of pembrolizumab combined with MK-4830 or MK-0482 in patients who haven't been treated previously for their lung cancer. It's part of a larger research project looking at different substudies under one main protocol.

What are the potential side effects?

Potential side effects may include immune-related reactions such as inflammation in various organs, infusion-related symptoms like fever or chills, fatigue, possible infection risks due to immune system suppression by the drugs being tested.

Eligibility Criteria

Inclusion Criteria

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

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I have not had any treatment for my advanced lung cancer.

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My lung cancer is at stage IV, confirmed by lab tests.

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

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My cancer tests show at least 1% of cells have PD-L1.

Exclusion Criteria

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

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I have been diagnosed with HIV.

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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, including recent heart attacks or severe heart failure.

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I stopped immunotherapy due to a severe side effect.

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I have been diagnosed with small cell lung cancer.

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

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I had major surgery less than 3 weeks ago.

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I've had lung radiation over 30 Gray in the last 6 months.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have previously been treated with immunotherapy for my cancer.

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

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I have another cancer that is getting worse or was treated in the last 2 years.

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I have had pneumonitis treated with steroids or have it now.

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I am currently being treated for an infection.

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I have received a transplant from another person.

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I have received chemotherapy or targeted therapy for my cancer after it spread.

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

2Treatment 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

MK-4830

2022

Completed Phase 2

~160