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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
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 belowSelect...
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:Select...
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
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 moreTrial 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
Positron Emission Tomography
2011
Completed Phase 2
~2200
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Pembrolizumab
2017
Completed Phase 3
~2850
Pemetrexed
2014
Completed Phase 3
~5550
Biospecimen Collection
2004
Completed Phase 3
~2020
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,010,237 Total Patients Enrolled
Hossein BorghaeiPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
10,042 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I took low-dose Methotrexate for a non-cancer condition and stopped at least 14 days ago.My hepatitis B is under control or I am cured of hepatitis C.I will follow guidelines for fluid drainage if treated with pemetrexed.My cancer shows a PD-L1 level of 1% or more.My heart is healthy and I haven't had serious heart disease or treatments that could harm my heart.My brain cancer hasn't worsened after treatment and I don't need immediate brain-specific treatment.I am taking medication to control seizures.My blood clotting time is within safe limits while on blood thinners.I have another cancer, but it won't affect this trial's treatment.I haven't taken steroids for at least 14 days.My brain cancer is stable after treatment, and I don't need immediate brain-specific treatment.My cancer can be measured by tests or seen on scans, taken within the last 4 weeks.I have NSCLC but haven't had checkpoint inhibitors for it. I've waited the required time after any previous treatments.I haven't needed treatment for an autoimmune disease in the last 2 years.I am not pregnant or breastfeeding and have confirmed this with a test.I haven't had a live vaccine in the last 30 days.You need to have a certain number of a type of white blood cells called neutrophils in your blood.Your platelet count is at least 100,000 per cubic millimeter within the last 14 days before the study starts.I am receiving radiation for symptom relief from bone metastasis.I have small brain metastases not requiring immediate treatment.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I am receiving radiation for symptom relief on bone metastasis.My cancer does not have treatable mutations like EGFR (except exon 20), BRAF (V600), ALK, or ROS1.I will use or am using effective birth control or abstaining from sex during and for 120 days after treatment.I do not have major GI issues like Crohn's disease causing diarrhea.Your liver function test results are within a certain range.Your kidney function, measured by a blood test, needs to be within a certain range.I haven't taken steroids or immunosuppressants in the last 7 days.I do not have an active tuberculosis infection.I am 18 years old or older.I do not have a history of lung conditions that needed steroids.I do not have any serious illnesses that could affect my safety or interfere with the study.I have advanced non-squamous NSCLC and cannot have chemo and radiation together.Your liver function test results must show that your SGPT (ALT) levels are not more than 5 times the upper limit of normal.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.Your total bilirubin level must be less than or equal to 1.5 mg/dL within 14 days before starting the study.My kidney function is good enough for certain cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (pembrolizumab, pemetrexed, carboplatin)
- Group 2: Arm B (pembrolizumab, pemetrexed, carboplatin)
- Group 3: Arm C (pembrolizumab, pembrolizumab, carboplatin)
Awards:
This trial has 2 awards, including:- 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.
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.
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