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Platinum-based Chemotherapy
MK-7684A + Chemotherapy for Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
Has not received prior systemic treatment for metastatic NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 40 months
Awards & highlights
Study Summary
This trial is testing whether adding MK-7684A to chemotherapy helps people with NSCLC live longer without their disease getting worse, and whether it helps people live longer overall, compared to adding pembrolizumab to chemotherapy.
Who is the study for?
This trial is for adults with Stage IV non-small cell lung cancer (NSCLC) who haven't had treatment for metastatic NSCLC, can expect to live at least 3 months, and have measurable disease. They must use effective contraception if of childbearing potential and not have HIV, Hepatitis B/C, other active cancers, CNS metastases, severe allergies to study drugs or their ingredients, certain lung conditions or infections requiring systemic therapy.Check my eligibility
What is being tested?
The trial tests whether a combination of Pembrolizumab/Vibostolimab with chemotherapy improves overall survival compared to just Pembrolizumab plus chemotherapy in first-time treatment patients with metastatic NSCLC. It's checking the effectiveness of MK-7684A coformulation against established treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs including lungs (pneumonitis), infusion-related reactions from the drug entering the body, fatigue from treatment burden on the body's resources, digestive issues like nausea or diarrhea due to gastrointestinal tract irritation by drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to be stage IV.
Select...
I haven't had systemic treatment for my advanced lung cancer.
Select...
I am using effective birth control or am confirmed to be unable to conceive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 40 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 40 months
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
Change from Baseline for Role Functioning Combined (Items 6 and 7) Score on the EORTC QLQ-C30
Change from Baseline in Chest Pain Score (Item 40) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + PemetrexedExperimental Treatment6 Interventions
Participants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Group II: Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + PemetrexedActive Control6 Interventions
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Nab-paclitaxel
2014
Completed Phase 3
~2030
Pemetrexed
2014
Completed Phase 3
~5250
Cisplatin
2013
Completed Phase 3
~1940
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,853 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,786 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot stop taking aspirin or NSAIDs for 5 days, except for low-dose aspirin.My lung cancer is confirmed to be stage IV.I have or had lung inflammation that needed steroids.I am not on high-dose steroids or other drugs that weaken my immune system.I haven't had systemic treatment for my advanced lung cancer.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have received treatment for cancer that has spread.I have another cancer that is getting worse or was treated in the last 3 years.I am severely allergic to vibostolimab, pembrolizumab, or any chemotherapy components.I have a history of HIV, Hepatitis B, or Hepatitis C.I have had a transplant of tissue or an organ from another person.I cannot or will not take folic acid or vitamin B12 supplements.I am currently being treated for an infection.I am using effective birth control or am confirmed to be unable to conceive.I have cancer that has spread to my brain or spinal cord.I have not received a live vaccine within the last 30 days.
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
- Group 2: Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
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.
Is this experiment still recruiting new test subjects?
"Yes, as of today this trial is still recruiting patients that meet the specified criteria. The listing for this trial was first posted on March 24th, 2020 and was last updated on November 4th, 2020."
Answered by AI
Are there any severe dangers associated with Pembrolizumab/Vibostolimab?
"Pembrolizumab/Vibostolimab is deemed safe by our team at Power. It scores a 3 on our safety metric, which takes into account data from Phase 3 trials as well as other clinical studies that support its safety."
Answered by AI
What are the big-picture goals of this clinical trial?
"The primary goal of this clinical trial, which will span a period of up to 42 months, is to assess Progression-Free Survival (PFS). Additionally, the trial will also collect data on secondary outcomes including Duration of Response (DOR) and Time to Deterioration (TTD) in Global Health Status/Quality of Life (Items 29 and 30) Combined Score and TTD in Role Functioning (Items 6 and 7) Combined Score."
Answered by AI
Is this clinical trial taking place across multiple states?
"Currently, University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031) in Fort Collins, New york, Stony Brook University-Cancer Center ( Site 0013) in Stony Brook, Virginia, and University of Virginia Cancer Center ( Site 0018) in Charlottesville, Maine are enrolling patients for this trial, with 9 other locations across the country to follow."
Answered by AI
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