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

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 358-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (107% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.

Conditions Studied

Metastatic Non Small Cell Lung Cancer

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
Daiichi Sankyo

236 total trials

What NCT05215340 shows while recruiting

NCT05215340 is an interventional study that assigns participants to a tested intervention. The registered 740 participants enrollment target is mid-sized for trials with a published cap, above the 358-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (107% higher).

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 names 20 study sites across 7 states, led by 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.

Learn More About Clinical Trials

Similar trials for Metastatic Non Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05215340's enrollment target sits among peer trials

740 6th of 31 higher than 26 of 31 other Metastatic Non Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Non Small Cell Lung Cancer 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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More recruiting context for NCT05215340

Source: ClinicalTrials.gov NCT05215340, the US trial registry maintained by the National Library of Medicine. NCT05215340 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.