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A Study of Dato-DXd for EGFR-Mutated Lung Cancer

This study is for people with locally advanced or metastatic non-small cell lung cancer that has a specific change in the EGFR gene (EGFRm) and has progressed after treatment with osimertinib. It aims to see how well Dato-DXd, given alone or with osimertinib, works compared to standard platinum-based chemotherapy. Researchers will measure how long participants live without their cancer getting worse (progression-free survival) for up to 2.5 years. You must be at least 18 years old and have non-squamous non-small cell lung cancer with specific EGFR mutations to be eligible. The study is currently recruiting 744 participants, but its overall status is unclear.

Study design
This is a Phase III, open-label study involving 744 participants. You would be randomly assigned to one of three treatment groups: Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based chemotherapy.
What's involved
You will receive study treatment until your cancer progresses, you experience unacceptable side effects, or other reasons for stopping treatment are met. After stopping treatment, you will have an end-of-treatment visit and safety follow-up for 28 to 35 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety assessments for 28 to 35 days after their last dose of study intervention. Progression-free survival is measured for up to 2.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06417814

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~744 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Dato-DXdOsimertinibPemetrexedCarboplatinCisplatin

At a glance

Recruiting sites
267 of 303 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free Survival (PFS)
Measured over Up to 2.5 years

Conditions

Metastatic Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

303 sites across 47 states
China38
Japan24
Spain19
France15
Brazil14
Germany14
India14
Italy12

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed non-squamous NSCLC.
Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKis\] sensitivity \[Ex19del, L858R, G719X, S768I, or L861Q\], either alone or in combination with other EGFR mutations, which may include T790M).
Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
Less than or equal to (\<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).
At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate bone marrow reserve and organ function within 7 days before randomization.

Exclusion

Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention.
Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
Has significant third-space fluid retention (example \[eg.\], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage.
History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
Unstable spinal cord compression and/or unstable brain metastases.
Participants with symptomatic brain metastases (including leptomeningeal involvement).
Clinically significant corneal disease.
Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections. Use of systemic antibiotics within 14 days of randomization.
Has known human immunodeficiency virus (HIV) infection that is not well controlled.

What this trial measures

  • Progression free Survival (PFS)Up to 2.5 years

    PFS is defined as the time from randomization to Blinded Independent Central Review (BICR)-assessed progression using RECIST v1.1 or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinical progression.