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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.

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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

FieldValue
Enrollment Target 304 participants
Start Date 2018-10-01
Est. Completion 2024-06-25
Phase Phase 3

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.