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NCT03976375 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 422
- Enrollment target
NCT03976375: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03976375 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 422 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03976375, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 422 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).
Primary Outcome
OS is defined as the time from randomization to the date of death due to any cause.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Docetaxel
- DRUG Lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2024-08-22 |
| Phase | Phase 3 |
What the finished NCT03976375 record still lists
NCT03976375 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03976375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03976375 about?
NCT03976375 is a clinical study titled "Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)". This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 m...
What is the current status of trial NCT03976375?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 422 participants. The study started on 2019-06-26. Estimated completion is 2024-08-22.
What interventions are being tested in trial NCT03976375?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Docetaxel (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT03976375?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03976375's enrollment target sits among peer trials
422 886th of 2000 higher than 1,111 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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