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Active, not recruiting Phase 3

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

NCT06417814 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2024-10-04
Last updated
2026-10-15

Condition(s) studied

Metastatic Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Dato-DXd →Osimertinib →Pemetrexed →Carboplatin →Cisplatin →

Dato-DXd: Dato-DXd will be administered as IV infusion.

Osimertinib: Osimertinib will be administered orally.

Pemetrexed: Pemetrexed will be administered as IV infusion.

Carboplatin: Carboplatin will be administered as IV infusion.

Cisplatin: Cisplatin will be administered as IV infusion.

Study summary

This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * \- 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 Criteria: * \- 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.

Primary outcome measure(s)

  • 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.

Trial sites (211)

FacilityCityRegionStatus
Research Site Fayetteville Arkansas
Research Site Fountain Valley California
Research Site San Diego California
Research Site Jacksonville Florida
Research Site Kansas City Missouri
Research Site New York New York
Research Site Maumee Ohio
Research Site Pittsburgh Pennsylvania
Research Site Nashville Tennessee
Research Site Fitzroy Australia
Research Site Heidelberg Australia
Research Site Kogarah Australia
Research Site Liverpool Australia
Research Site Nedlands Australia
Research Site St Leonards Australia
Research Site Westmead Australia
Research Site Woolloongabba Australia
Research Site Charleroi Belgium
Research Site Edegem Belgium
Research Site Ghent Belgium
Research Site Hasselt Belgium
Research Site Jette Belgium
Research Site Namur Belgium
Research Site Roeselare Belgium
Research Site Barretos Brazil
Research Site Betim Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site Rio de Janeiro Brazil
Research Site Rio de Janeiro Brazil
Research Site Rio de Janeiro Brazil
Research Site São Paulo Brazil
Research Site Brampton Ontario
Research Site Toronto Ontario
Research Site Toronto Ontario
Research Site Montreal Quebec
Research Site Québec Quebec
Research Site Baoding China
Research Site Beijing China
Research Site Beijing China

+ 171 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06417814 on ClinicalTrials.gov ↗ ← All trials in the UK