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Alkylating agents

Pembrolizumab + Chemotherapy for Lung Cancer

Phase 3

Waitlist Available

Led By Hossein Borghaei

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Must not have

Patients must not have known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better

Patients with known EGFR mutations (except exon 20 insertion), BRAF mutations (V600) or ALK or ROS1 translocations or other driver mutations that can be treated with oral tyrosine kinase inhibitors are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post treatment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with advanced non-squamous non-small cell lung cancer.

Who is the study for?

Adults with stage IV non-squamous non-small cell lung cancer, who have not had previous systemic chemotherapy for advanced disease. They must have a PD-L1 expression TPS of at least 1%, be in good physical condition (ECOG 0-1), and may have treated brain metastases if stable. Patients should not be pregnant or breastfeeding, must agree to use contraception, and cannot have certain serious illnesses or organ dysfunctions.

What is being tested?

The trial is testing the effectiveness of pembrolizumab alone as an initial treatment followed by pemetrexed and carboplatin with/without continued pembrolizumab after disease progression versus starting with all three drugs together then maintaining with pembrolizumab and pemetrexed. It aims to see which method is better for treating patients.

What are the potential side effects?

Possible side effects include immune system reactions that can affect organs, infusion-related reactions, fatigue, nausea, blood disorders like low white cell count increasing infection risk. Pembrolizumab might also cause skin issues or hormonal gland problems like thyroid dysfunction.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My hepatitis B is under control or I am cured of hepatitis C.

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My cancer shows a PD-L1 level of 1% or more.

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I am 18 years old or older.

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I have advanced non-squamous NSCLC and cannot have chemo and radiation together.

Exclusion Criteria

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

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My heart is healthy and I haven't had serious heart disease or treatments that could harm my heart.

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My cancer does not have treatable mutations like EGFR (except exon 20), BRAF (V600), ALK, or ROS1.

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I do not have major GI issues like Crohn's disease causing diarrhea.

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I do not have an active tuberculosis infection.

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I do not have a history of lung conditions that needed steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall survival (OS)

Secondary study objectives

Best objective response

Incidence of adverse events

PD-L1 positivity

+1 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (pembrolizumab, pemetrexed, carboplatin)Experimental Treatment7 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Within 6 weeks of disease progression, patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Cycles repeat every 21 days for up to 2 years for pembrolizumab in the absence of disease progression or unacceptable toxicity and until to disease progression for pemetrexed. Patients undergo MRI during screening, CT scan and blood sample collection throughout the study, and may undergo PET scan throughout the study.

Group II: Arm A (pembrolizumab, pemetrexed, carboplatin)Experimental Treatment7 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Within 6 weeks of disease progression, patients receive pemetrexed IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then may receive pemetrexed IV over 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI during screening, CT scan and blood sample collection throughout the study, and may undergo PET scan throughout the study.

Group III: Arm C (pembrolizumab, pembrolizumab, carboplatin)Active Control7 Interventions

Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Cycles repeat every 21 days for up to 2 years for pembrolizumab in the absence of disease progression or unacceptable toxicity and until to disease progression for pemetrexed. Patients undergo MRI during screening, CT scan and blood sample collection throughout the study, and may undergo PET scan throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Computed Tomography

2017

Completed Phase 2

~2740