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NCT06417814Phase 3RECRUITING

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

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).

Conditions
Metastatic Non-small Cell Lung Cancer
Interventions / Drugs
Dato-DXdOsimertinibPemetrexedCarboplatinCisplatin
View on ClinicalTrials.gov ↗
Sponsor
AZN
AstraZeneca
Oncology/Respiratory
F16/100
Study Details
Enrollment744 participants
Primary Completion—
Lead SponsorAstraZeneca
Data Retrieved2026-04-11 02:55:19.909596+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 744 participants
Sponsor Catalyst Profile

AstraZeneca (AZN) is the sponsoring company for this trial. BiotechSign currently grades this company F (16/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

AZN Full Pipeline →All Companies →
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