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PD-L1 Inhibitor

Coformulated Pembrolizumab/Vibostolimab for Non-Small Cell Lung Cancer

Phase 3
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
Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
Must not have
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~68 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether a combination of two drugs is better than just one of the drugs for overall survival and progression-free survival in people with a certain kind of cancer.

Who is the study for?
This trial is for adults with Stage IV non-small cell lung cancer (NSCLC) showing PD-L1 expression in at least 1% of tumor cells. Participants must not need EGFR-, ALK-, or ROS1-directed therapy, have a life expectancy of over 3 months, and an ECOG score of 0-1. Women must use effective contraception or be abstinent, and all participants should have adequate organ function.
What is being tested?
The study tests if a combination drug (pembrolizumab/vibostolimab) is more effective than pembrolizumab alone in improving survival without cancer progression. It focuses on patients whose tumors express the protein PD-L1 to varying degrees and measures overall survival and disease progression.
What are the potential side effects?
Potential side effects include allergic reactions to the drugs' components, immune system-related issues such as inflammation in various organs, fatigue, possible infections due to lowered immunity, and complications related to pre-existing conditions like pneumonitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor shows PD-L1 expression in at least 1% of cells.
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My lung cancer is confirmed to be at stage IV.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of Hepatitis B or an active Hepatitis C infection.
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I have had pneumonitis treated with steroids or have it now.
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I have been treated with a drug targeting the TIGIT pathway before.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I have had chemotherapy or targeted therapy for my advanced lung cancer.
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I am currently being treated for an infection.
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I have been treated with specific immune therapy drugs before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~68 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~68 months for reporting.

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) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
Secondary study objectives
Pain
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
+46 more

Awards & Highlights

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.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab/VibostolimabExperimental Treatment1 Intervention
Participants will receive pembrolizumab/vibostolimab as a coformulation (MK-7684A).
Group II: PembrolizumabActive Control1 Intervention
Participants will receive pembrolizumab (MK-3475) alone.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,224 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,187,539 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,900 Previous Clinical Trials
8,089,170 Total Patients Enrolled

Media Library

Pembrolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04738487 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Pembrolizumab/Vibostolimab, Pembrolizumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04738487 — Phase 3
Pembrolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04738487 — Phase 3
~428 spots leftby Dec 2026
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