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NCT05215340 · ClinicalTrials.gov registry record · Phase 3

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

A Phase 3 study of Metastatic Non Small Cell Lung Cancer, sponsored by Daiichi Sankyo.

Recruiting
Registry status
Phase 3
Development phase
740
Enrollment target
20
Study locations

NCT05215340 is a Phase 3 study of Metastatic Non Small Cell Lung Cancer that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 740 participants, above the 369-participant average among 30 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT05215340, a Phase 3 study of Metastatic Non Small Cell Lung Cancer, is actively recruiting participants, sponsored by Daiichi Sankyo.

RECRUITING
Registry status
Phase 3
Development phase
740 participants
Enrollment target
20
Study locations

Study Summary

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.

Interventions

  • DRUG Pembrolizumab
  • DRUG Datopotamab Deruxtecan

Study Locations (20)

California

  • UCLA HemOnc - Clinical Research Unit - Los Angeles
  • Compassionate Cancer Care Medical Group - Riverside
  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
  • Ridley-Tree Cancer Center - Santa Barbara
  • PIH Health Whittier Hospital - Whittier
  • The Oncology Institute of Hope and Innovation - Whittier

Massachusetts

  • Dana-Farber Cancer Institute - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • DFCI - Steward St. Elizabeth's Medical Center - Boston
  • Dana Farber Cancer Institute - Foxborough - Foxborough
  • Dana Farber Cancer Institute - Milford Medical Center - Milford
  • DFCI - South Shore Hospital - South Weymouth

New Jersey

  • Astera Cancer Care - East Brunswick
  • Regional Cancer Care Associates LLC - Freehold
  • Cooperman Barnabas Medical Center - New Brunswick

Maryland

  • Johns Hopkins University - Baltimore
  • American Oncology Partners of Maryland - Bethesda

Arizona

  • Ironwood Cancer and Research Center - Chandler

Colorado

  • Uch-Mhs D/B/A Memorial Health System - Colorado Springs

New Hampshire

  • Dartmouth Hitchcock Medical Center - Lebanon

Trial Details

FieldValue
Enrollment Target 740 participants
Start Date 2022-03-04
Est. Completion 2028-04-30
Phase Phase 3

Sponsor

Daiichi Sankyo

236 total trials

What the Registry Record Tells You About NCT05215340

The ClinicalTrials.gov registry entry for NCT05215340 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 740 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 369-participant average among 30 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (101% higher). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT05215340 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Massachusetts, New Jersey.

Frequently Asked Questions

What is clinical trial NCT05215340 about?

NCT05215340 is a clinical study titled "Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations". This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.

What is the current status of trial NCT05215340?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 740 participants. The study started on 2022-03-04. Estimated completion is 2028-04-30.

What conditions does trial NCT05215340 study?

This clinical trial studies the following conditions: Metastatic Non Small Cell Lung Cancer.

What interventions are being tested in trial NCT05215340?

The interventions under investigation include: Pembrolizumab (DRUG), Datopotamab Deruxtecan (DRUG).

Who is sponsoring clinical trial NCT05215340?

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

Where is trial NCT05215340 being conducted?

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

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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.