AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Study summary

A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedChemotherapy and Cross-over to Osimertinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 7, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?150 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: AstraZeneca
Interventions being studied: Drug: Chemotherapy; Drug: Cross-over to Osimertinib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Treatment approach

Targeted therapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Subjects with histologically or cytologically documented NSCLC.
Locally advanced or metastatic NSCLC
Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment
Eligible to receive treatment with the selected doublet-chemotherapy
Central confirmation of T790M+ mutation status
World Health Organization (WHO) performance status 0-1
At least one lesion, not previously irradiated.

Reasons someone may not be able to joinExclusion criteria

Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
Treatment with more than one prior line of treatment for advanced NSCLC
Treatment with an approved EGFR-TKI (e.g.,erlotinib, gefitinib, afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment
Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
Previous treatment with Osimertinib, or a 3rd generation EGFR TKI For subjects who cross-over to Osimertinib:
Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review.
At least 14 days since last dose of platinum-based doublet chemotherapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Research SiteAnaheim, California
Research SiteOrange, California
Research SiteSanta Rosa, California
Research SiteNorwalk, Connecticut
Research SiteGainesville, Florida
Research SiteOrlando, Florida
Research SitePembroke Pines, Florida
Research SiteAtlanta, Georgia
Research SitePark Ridge, Illinois
Research SiteIndianapolis, Indiana
Research SiteMarrero, Louisiana
Research SiteChevy Chase, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 7, 2025. Always confirm current availability with the study team.

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