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NCT03631706 · ClinicalTrials.gov registry record · Phase 3
M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
A Phase 3 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
NCT03631706 is a Phase 3 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 304 participants.
The verdict
NCT03631706, a Phase 3 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.
Interventions
- DRUG Pembrolizumab
- DRUG M7824
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2024-06-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03631706
The ClinicalTrials.gov registry entry for NCT03631706 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03631706 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03631706 about?
NCT03631706 is a clinical study titled "M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)". The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The...
What is the current status of trial NCT03631706?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2018-10-01. Estimated completion is 2024-06-25.
What interventions are being tested in trial NCT03631706?
The interventions under investigation include: Pembrolizumab (DRUG), M7824 (DRUG).
Who is sponsoring clinical trial NCT03631706?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
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