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NCT03829332 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 623
- Enrollment target
NCT03829332 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 623 participants.
The verdict
NCT03829332, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 623 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%. The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Lenvatinib
- DRUG Placebo for lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 623 participants |
| Start Date | 2019-03-13 |
| Est. Completion | 2024-04-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03829332
The ClinicalTrials.gov registry entry for NCT03829332 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 623 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03829332 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03829332 about?
NCT03829332 is a clinical study titled "Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)". The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (N...
What is the current status of trial NCT03829332?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 623 participants. The study started on 2019-03-13. Estimated completion is 2024-04-24.
What interventions are being tested in trial NCT03829332?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Lenvatinib (DRUG), Placebo for lenvatinib (DRUG).
Who is sponsoring clinical trial NCT03829332?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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