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Pembrolizumab + Chemotherapy 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
Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy
Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 27 months
Awards & highlights
Study Summary
This trial is testing the combination of pembrolizumab with different chemotherapies and/or other immunotherapy drugs to see if it is more effective and has fewer side effects than other treatments for people with squamous or non-squamous NSCLC.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) who haven't had treatment before. They should not be eligible for approved targeted therapies, have good organ function, and agree to use contraception. Pregnant or breastfeeding individuals, those with certain heart conditions, active infections, recent major surgery or live vaccines are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of pembrolizumab combined with chemotherapy plus one of four investigational agents (vibostolimab, boserolimab, MK-4830, or MK-0482) in patients with untreated advanced NSCLC. It's part of a larger research project exploring pembrolizumab treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting various organs due to pembrolizumab and its combination drugs. Chemotherapy may cause nausea, fatigue, hair loss and increased risk of infection. Specific side effects depend on which investigational agent is used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My nonsquamous NSCLC is not eligible for approved targeted treatments.
Select...
My lung cancer is confirmed to be stage IV.
Select...
I haven't had systemic treatment for my metastatic NSCLC.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Secondary outcome measures
Number of Participants Who Discontinue 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)
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
8Treatment groups
Experimental Treatment
Group I: Pembrolizumab+Vibostolimab+Carboplatin + PemetrexedExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS pemetrexed 500 mg/m^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group II: Pembrolizumab+Vibostolimab+Carboplatin + PaclitaxelExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg intravenously (IV) PLUS vibostolimab IV PLUS carboplatin Area Under the Concentration-Time Curve (AUC) 6 IV PLUS paclitaxel 200 mg/m^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group III: Pembrolizumab+MK-4830+Carboplatin+PemetrexedExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS pemetrexed 500 mg/m^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group IV: Pembrolizumab+MK-4830+Carboplatin+PaclitaxelExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group V: Pembrolizumab+MK-0482+Carboplatin+PemetrexedExperimental Treatment1 Intervention
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS pemetrexed 500 mg/m^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group VI: Pembrolizumab+MK-0482+Carboplatin+PaclitaxelExperimental Treatment1 Intervention
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group VII: Pembrolizumab+Boserolimab+Carboplatin+PemetrexedExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS pemetrexed 500 mg/m^2 IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).
Group VIII: Pembrolizumab+Boserolimab+Carboplatin+PaclitaxelExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,468 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,193 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,126 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to carboplatin, paclitaxel, pemetrexed, or their ingredients.I have a GI condition or liver issues that could affect medication absorption.I have been diagnosed with small cell lung cancer.I have not received any live vaccines other than approved COVID-19 vaccines in the last 30 days.I am currently being treated for an infection.I had major surgery less than 3 weeks ago.I agree to use birth control and not donate sperm during and up to 6 months after treatment.I stopped immunotherapy due to a severe side effect.I can provide a recent or archived tumor sample not previously treated with radiation.I have a history of Hepatitis B or an active Hepatitis C infection.I am on chemotherapy and have serious digestive system issues.I've had lung radiation over 30 Gray in the last 6 months.I have fluid buildup in my abdomen or around my lungs and am taking Alimta.My organs are functioning well enough for treatment.I haven't had cancer treatment in the last 4 weeks or have recovered from its side effects.I am taking medication that affects liver enzymes and can't stop during the study.I am not pregnant or breastfeeding, and if I can have children, I agree to use contraception as required.I cannot or will not take folic acid or vitamin B12 supplements.My nonsquamous NSCLC is not eligible for approved targeted treatments.My lung cancer is confirmed to be stage IV.I have cancer that has spread to my brain or spinal cord.You had a bad allergic reaction to a type of medicine called monoclonal antibodies in the past.I cannot stop taking aspirin or NSAIDs for 5 days, or 8 days for long-acting ones.I am taking medication that affects liver enzymes and cannot stop during the study.I have received an organ or tissue transplant from another person.I have serious heart problems, including recent heart attacks or severe heart failure.I have been treated for an autoimmune disease in the last 2 years.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have moderate nerve pain or tingling.I have another cancer that is getting worse or was treated in the last 2 years.I will not need any cancer treatment other than the study's while participating.I haven't had systemic treatment for my metastatic NSCLC.I have been treated with immunotherapy targeting PD-1, PD-L1, or PD-L2.I have a known history of HIV.I have received chemotherapy or targeted therapy for my cancer after it spread.I have had or currently have lung inflammation treated with steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab+MK-0482+Carboplatin+Paclitaxel
- Group 2: Pembrolizumab+Vibostolimab+Carboplatin + Paclitaxel
- Group 3: Pembrolizumab+Vibostolimab+Carboplatin + Pemetrexed
- Group 4: Pembrolizumab+Boserolimab+Carboplatin+Paclitaxel
- Group 5: Pembrolizumab+Boserolimab+Carboplatin+Pemetrexed
- Group 6: Pembrolizumab+MK-4830+Carboplatin+Pemetrexed
- Group 7: Pembrolizumab+MK-0482+Carboplatin+Pemetrexed
- Group 8: Pembrolizumab+MK-4830+Carboplatin+Paclitaxel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many sites is this study being conducted?
"Currently, this study is enrolling patients from the University of California San Francisco ( Site 0007) in San Francisco, California, Banner MD Anderson Cancer Center ( Site 0001) in Gilbert, Arizona and City of Hope ( Site 0014). Additionally, there are 18 other locations that are participating."
Answered by AI
Is this study still recruiting patients for participation?
"From what is published on clinicaltrials.gov, it seems as if this study is still recruiting patients. The trial was initially posted on December 19th, 2019 with the most recent update occurring on October 31st, 2020."
Answered by AI
Has Pembrolizumab been cleared by the FDA?
"Pembrolizumab falls into Phase 2 of clinical trials, so there is some data indicating that it is safe but no efficacy data yet. Our team at Power rates its safety as a 2."
Answered by AI
What other investigations have been conducted with Pembrolizumab?
"The first clinical trial for pembrolizumab was at City of Hope Comprehensive Cancer Center in 1997. As of now, there have been a total of 1965 completed trials with 2127 more active ones. A large portion of these active trials are taking place in San Francisco, California."
Answered by AI
What are the usual indications for Pembrolizumab?
"Pembrolizumab is a medication that can be used to fight cancerous growths, unresectable melanoma, and microsatellite instability high."
Answered by AI
How many people does this research project allow to enroll?
"Yes, you are correct. The trial is looking for 360 participants and is being conducted at 18 different locations. According to the clinicaltrials.gov website, the last update was on 10/31/2022 and it was first posted on 12/19/2019."
Answered by AI
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