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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: Completed Phase 3 study, sponsored by EMD Serono Research & Development Institute.
NCT03631706 is a Phase 3 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 304 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
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 |
What the finished NCT03631706 record still lists
NCT03631706 is an interventional study that assigns participants to a tested intervention. The registered 304 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 (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03631706 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03631706's enrollment target sits among peer trials
304 1117th of 2000 higher than 882 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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