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NCT03829319 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 761
- Enrollment target
NCT03829319 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 761 participants.
The verdict
NCT03829319, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 761 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer. The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 761 participants |
| Start Date | 2019-03-25 |
| Est. Completion | 2024-08-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03829319
The ClinicalTrials.gov registry entry for NCT03829319 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 761 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 5 interventions - of which Pembrolizumab is the first listed.
NCT03829319 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03829319 about?
NCT03829319 is a clinical study titled "Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)". The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer. The primary study hypotheses state t...
What is the current status of trial NCT03829319?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 761 participants. The study started on 2019-03-25. Estimated completion is 2024-08-30.
What interventions are being tested in trial NCT03829319?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT03829319?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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