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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
Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 14 days prior to date of registration will be allowed. Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I took low-dose Methotrexate for a non-cancer condition and stopped at least 14 days ago.
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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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My brain cancer hasn't worsened after treatment and I don't need immediate brain-specific treatment.
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I am taking medication to control seizures.
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My blood clotting time is within safe limits while on blood thinners.
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My heart function is classified as class 2B or better, despite my history of heart issues or treatments.
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I have another cancer, but it won't affect this trial's treatment.
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I haven't taken steroids for at least 14 days.
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My cancer can be measured by tests or seen on scans, taken within the last 4 weeks.
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I have advanced non-squamous NSCLC and cannot have combined chemo and radiation.
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I am not pregnant or breastfeeding and have confirmed this with a test.
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I am 18 years old or older.
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My cancer shows a PD-L1 level of 1% or more.
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I am receiving radiation for symptom relief from bone metastasis.
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I have small brain metastases not requiring immediate treatment.
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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer shows a PD-L1 level of 1% or more.
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I will use or am using effective birth control or abstaining from sex during and for 120 days after treatment.
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I am 18 years old or older.
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My heart function is classified as class 2B or better, despite my history of heart issues or treatments.
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I do not have any serious illnesses that could affect my safety or interfere with the study.
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I have advanced non-squamous NSCLC and cannot have chemo and radiation together.
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My cancer shows a PD-L1 level of 1% or more.
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My heart function is classified as class 2B or better, despite my history of heart issues or treatments.
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My kidney function is good enough for certain cancer treatments.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Best objective response
Incidence of adverse events
PD-L1 positivity
+1 more

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
Biospecimen Collection
2004
Completed Phase 2
~1920
Carboplatin
2014
Completed Phase 3
~6670
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Pembrolizumab
2017
Completed Phase 2
~1950
Positron Emission Tomography
2008
Completed Phase 2
~2260
Pemetrexed
2014
Completed Phase 3
~5250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,603 Previous Clinical Trials
40,912,675 Total Patients Enrolled
Hossein BorghaeiPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
10,042 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03793179 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm B (pembrolizumab, pemetrexed, carboplatin), Arm A (pembrolizumab, pemetrexed, carboplatin), Arm C (pembrolizumab, pembrolizumab, carboplatin)
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03793179 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03793179 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of illnesses or diseases is Pembrolizumab mostly effective for?

"Pembrolizumab is an immunotherapy medication that can be used to treat various types of cancer, such as malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

What does the existing literature say about Pembrolizumab?

"Pembrolizumab is being trialed in 1664 different ongoing studies, with 337 of those in Phase 3. Though many of these trials are based in Shanghai, there are 74921 total locations for these trials."

Answered by AI

What is the general consensus on Pembrolizumab's effectiveness?

"Pembrolizumab has received a safety score of 3. This is because it is a Phase 3 trial, which means that there is not only data supporting its efficacy, but also multiple rounds of data affirming its safety."

Answered by AI

Are people with this condition still able to enroll in the trial at this time?

"That is correct, according to the information available on clinicaltrials.gov, this clinical trial is still recruiting participants. The study was originally posted on 2/28/2019, and the most recent edit was on 11/3/2022. They are hoping to enroll 846 participants from 100 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Alaska
California
Other
How old are they?
18 - 65
What site did they apply to?
Anchorage Oncology Centre
Cancer Center at Saint Joseph's
LSU Health Sciences Center at Shreveport
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

I have had two rounds of chemotherapy and no other medications.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Alegent Health Mercy Hospital: < 48 hours
Average response time
  • < 2 Days
~295 spots leftby Dec 2028