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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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 422 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03976375
The ClinicalTrials.gov registry entry for NCT03976375 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 422 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.
NCT03976375 reports 0 study locations.
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.
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