A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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NCT06417814 · readout in 42 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

744estimated

Sites

303

Countries

Australia, Belgium, Brazil +24

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

2024-10-04

actual

When the study began enrolling

Primary completion

2026-09-30

estimated

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

Study completion

2028-09-27

estimated

The whole study's end, after follow-up

First posted

2024-05-16

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-14

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: Dato-DXd — also filed as DS-1062a
Drug: Osimertinib — also filed as Tagrisso, AZD9291
Drug: Pemetrexed
Drug: Carboplatin
Drug: Cisplatin

Primary outcome

what the primary-completion date above is the date OF

Progression free Survival (PFS)

measured Up to 2.5 years

Publications

PMID 41466843 — 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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