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

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NCT05215340 · readout in 1,293 d

Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With AstraZeneca, Merck Sharp & Dohme LLC.

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

740actual

Sites

234

Countries

Argentina, Australia, Austria +25

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2022-03-04

actual

When the study began enrolling

Primary completion

2030-03-04

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2032-03-04

estimated

The whole study's end, after follow-up

First posted

2022-01-31

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-19

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Metastatic Non Small Cell Lung Cancer

Interventions

Drug: Datopotamab Deruxtecan — also filed as Dato-DXd, DATROWAY®
Drug: Pembrolizumab — also filed as KEYTRUDA®

Primary outcomes

what the primary-completion date above is the date OF

Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab

measured From randomization until disease progression or death (whichever occurs first), up to approximately 46 months

Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab

measured From randomization until date of death due to any cause, up to approximately 72 months

Publications

PMID 37249038 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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