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Monoclonal Antibodies
Pembrolizumab Combo for 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
Provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Has a histologically- or cytologically-confirmed diagnosis of Stage IV (American Joint Committee on Cancer [AJCC] v 8) NSCLC and has not had prior systemic therapy for advanced disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~2 years
Awards & highlights
Study Summary
This trial will study whether a biomarker-based classifier can help predict how well a patient with NSCLC will respond to immunotherapy or targeted therapy.
Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) who haven't had systemic therapy for it can join. They must have specific gene profiles, good organ function, and an ECOG status of 0-1. Men and women must agree to contraception; women cannot be pregnant or breastfeeding. People with certain heart conditions, active infections like hepatitis B/C or HIV, recent major surgery, other cancers within 3 years, severe allergies to trial drugs or their ingredients are excluded.Check my eligibility
What is being tested?
The study tests pembrolizumab combined with quavonlimab, favezelimab, or lenvatinib in NSCLC patients based on their gene expression profile (GEP) and tumor mutational burden (TMB). The goal is to see if these combinations improve response rates compared to historical data for different GEP/TMB groups.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the liver or lungs, infusion reactions from the drug entering the body, fatigue, digestive issues such as nausea and diarrhea. Each drug also has unique risks that will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have provided a sample of my tumor that has not been treated with radiation.
Select...
My lung cancer is at stage IV and I haven't had systemic therapy for it.
Select...
My cancer does not require treatment targeting EGFR, ALK, ROS1, or B-Raf mutations.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~2 years
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) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
Secondary outcome measures
Number of Participants Discontinuing Study Drug Due to AEs
Number of Participants Experiencing Adverse Events (AEs)
Overall Survival (OS)
+1 moreTrial Design
12Treatment groups
Experimental Treatment
Group I: GEP low TMB low: Pembrolizumab + QuavonlimabExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus quavonlimab at the Recommended Phase 2 Dose ([RP2D], dose and schedule based on study NCT03179436) until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Group II: GEP low TMB low: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus lenvatinib 20 mg once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
Group III: GEP low TMB low: Pembrolizumab + FavezelimabExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus favezelimab 200 mg or 800 mg Q3W until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Group IV: GEP low TMB hi: Pembrolizumab + QuavonlimabExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus quavonlimab at the RP2D (dose and schedule based on study NCT03179436) until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Group V: GEP low TMB hi: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus lenvatinib 20 mg once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
Group VI: GEP low TMB hi: Pembrolizumab + FavezelimabExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus favezelimab 200 mg or 800 mg Q3W until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Group VII: GEP hi TMB low: Pembrolizumab + QuavonlimabExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus quavonlimab at the RP2D (dose and schedule based on study NCT03179436) until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Group VIII: GEP hi TMB low: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus lenvatinib 20 mg once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
Group IX: GEP hi TMB low: Pembrolizumab + FavezelimabExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus favezelimab 200 mg or 800 mg Q3W until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Group X: GEP hi TMB hi: Pembrolizumab + QuavonlimabExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus quavonlimab at the RP2D (dose and schedule based on study NCT03179436) until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Group XI: GEP hi TMB hi: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus lenvatinib 20 mg once daily until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years). Participants completing 35 infusions of pembrolizumab may continue with lenvatinib alone until disease progression or toxicity.
Group XII: GEP hi TMB hi: Pembrolizumab + FavezelimabExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg Q3W plus favezelimab 200 mg or 800 mg Q3W until disease progression, or until the participant has received 35 administrations of pembrolizumab (approximately 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Favezelimab
2016
Completed Phase 1
~490
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,510 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,235 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,168 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease treated with strong medication in the last 2 years.My cancer has spread to major blood vessels.My NSCLC can potentially be cured with surgery or targeted radiation.The doctors can see and measure your disease using a specific assessment method called RECIST 1.1.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab, favezelimab, or lenvatinib, or any of the ingredients in these medications.I have an active tuberculosis infection.I have provided a sample of my tumor that has not been treated with radiation.I have had chemotherapy for my lung cancer that has spread.I don't expect to need any other cancer treatments while in this study.I have been treated with a drug targeting the LAG-3 receptor before.I haven't had major heart problems or a stroke in the last year.I have received an organ or tissue transplant from another person.I have not fully recovered from major surgery or had surgery within the last 3 weeks.I have another cancer that is getting worse or was treated in the last 3 years.I have cancer that has spread to my brain or spinal cord.I have severe digestive issues that could affect medication absorption.I have not had significant coughing up of blood or tumor bleeding in the last 2 weeks.I have been treated with specific immune therapy before.I have been treated with a drug targeting blood vessel growth in cancer.I haven't had any radiotherapy in the last 2 weeks or lung radiation over 30 Gy in the last 6 months.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.My cancer does not require treatment targeting EGFR, ALK, ROS1, or B-Raf mutations.I am not pregnant, breastfeeding, and if able to have children, I agree to use contraception during and after the study.I have had or currently have lung inflammation treated with steroids.I am currently being treated for an infection with medication.I have a history of hepatitis B or active hepatitis C.My lung cancer is at stage IV and I haven't had systemic therapy for it.I agree to use contraception and not donate sperm for 120 days after my last treatment dose.I am a woman of childbearing potential and my recent pregnancy test was negative.Your heart takes too long to recharge between beats, which can be dangerous.I have fluid buildup in my abdomen or around my lungs.I have not taken any cancer treatment or experimental drugs in the last 4 weeks.My organs are functioning well.You have been diagnosed with HIV in the past.I am fully active or can carry out light work.I have not received a live vaccine in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: GEP hi TMB low: Pembrolizumab + Favezelimab
- Group 2: GEP hi TMB low: Pembrolizumab + Quavonlimab
- Group 3: GEP low TMB hi: Pembrolizumab + Lenvatinib
- Group 4: GEP low TMB low: Pembrolizumab + Quavonlimab
- Group 5: GEP low TMB low: Pembrolizumab + Lenvatinib
- Group 6: GEP low TMB hi: Pembrolizumab + Quavonlimab
- Group 7: GEP low TMB hi: Pembrolizumab + Favezelimab
- Group 8: GEP low TMB low: Pembrolizumab + Favezelimab
- Group 9: GEP hi TMB hi: Pembrolizumab + Quavonlimab
- Group 10: GEP hi TMB low: Pembrolizumab + Lenvatinib
- Group 11: GEP hi TMB hi: Pembrolizumab + Favezelimab
- Group 12: GEP hi TMB hi: Pembrolizumab + Lenvatinib
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.
What conditions is Favezelimab routinely prescribed for?
"Favezelimab is an intervention that can be leveraged to treat patients with unresectable melanoma, elevated microsatellite instability, and higher risk of recurrence."
Answered by AI
How many participants are currently involved in this clinical investigation?
"As this medical trial is no longer open for enrollment, the last edit was logged on August 23rd 2022. Conversely, if you are interested in alternative trials there are 1,912 studies recruiting participants with advanced non-small cell lung cancer (nsclc) and a further 1,032 researching Favezelimab actively accepting patients."
Answered by AI
Is there any record of prior experiments conducted with Favezelimab?
"Favezelimab has been subject to 302 trials since its initial study at City of Hope in 2010. Currently, 1032 clinical trials are enrolling with a considerable number being conducted out of Baltimore, Maryland."
Answered by AI
Is enrollment still available for this research endeavor?
"This medical trial has ceased its search for participants. First posted in October 2018, and most recently updated on August 23rd 2022, the study is no longer enrolling patients. There are numerous other studies recruiting however; specifically 1912 trials actively seeking advanced non small cell lung cancer (nsclc) candidates and 1032 clinical trials recruiting Favezelimab volunteers."
Answered by AI
Are there any associated risks to being administered Favezelimab?
"Although Favezelimab's efficacy has yet to be established, the existence of some safety data warranted a score of 2."
Answered by AI
How many sites are overseeing the execution of this experiment?
"Presently, this clinical trial is operating in 21 separate locations across the United States. These sites are situated in Baltimore, Pittsburgh and Rochester among other places. Signing up for a location closest to you can alleviate travel stress if you decide to join."
Answered by AI
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