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NCT04042701 · ClinicalTrials.gov registry record · Phase 1

DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer

A Phase 1 study of Breast Cancer and Non-Small-Cell Lung Carcinoma, sponsored by Daiichi Sankyo.

Active
Registry status
Phase 1
Development phase
115
Enrollment target
20
Study locations

NCT04042701 is a Phase 1 study of Breast Cancer and Non-Small-Cell Lung Carcinoma that is active but no longer recruiting, run by Daiichi Sankyo. The registered enrollment target is 115 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT04042701, a Phase 1 study of Breast Cancer and Non-Small-Cell Lung Carcinoma, is active but no longer recruiting, sponsored by Daiichi Sankyo.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
115 participants
Enrollment target
20
Study locations

Study Summary

This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.

Conditions Studied

Breast Cancer Non-Small-Cell Lung Carcinoma

Interventions

  • DRUG Pembrolizumab
  • DRUG Trastuzumab deruxtecan (DS-8201a)

Study Locations (20)

Other

  • Institut Bergonie - Bordeaux
  • Centre Hospitalier Intercommunal de Créteil - Créteil
  • CHUTimone - Marseille
  • Institut PAOLI-CALMETTES - Marsielle
  • CHU de Poitiers - Poitiers
  • Univ. du Cancer de Toulouse - Toulouse
  • Institut Gustave Roussy - Villejuif
  • Hospital Teresa Herrera (C.H.U.A.C) - A Coruña
  • Inst. Oncologico Baselga Hospital Quiron - Barcelona
  • Hospital de la Santa Creu i de Sant Pau - Barcelona

Florida

  • Cancer Specialists of North Florida (Cbo) - Jacksonville
  • Moffitt Cancer Center - Tampa
  • Moffit Cancer Center - Tampa

California

  • Univ. of Cali. San Francisco Medical Center - San Francisco

Connecticut

  • Yale Cancer Center - New Haven

Maryland

  • Center for Cancer & Blood Disorders - Bethesda

Massachusetts

  • Massachusetts General Hospital Cancer Center - Boston

Missouri

  • Siteman Cancer Center-Washington University - St Louis

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2020-02-10
Est. Completion 2027-03-31
Phase Phase 1

Sponsor

Daiichi Sankyo

236 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04042701

The ClinicalTrials.gov registry entry for NCT04042701 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT04042701 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Florida, California.

Frequently Asked Questions

What is clinical trial NCT04042701 about?

NCT04042701 is a clinical study titled "DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer". This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.

What is the current status of trial NCT04042701?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2020-02-10. Estimated completion is 2027-03-31.

What conditions does trial NCT04042701 study?

This clinical trial studies the following conditions: Breast Cancer, Non-Small-Cell Lung Carcinoma.

What interventions are being tested in trial NCT04042701?

The interventions under investigation include: Pembrolizumab (DRUG), Trastuzumab deruxtecan (DS-8201a) (DRUG).

Who is sponsoring clinical trial NCT04042701?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04042701 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.