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Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M

NCT02841579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-01-28

Study results available
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Summary

The primary goal is to evaluate the efficacy of osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria.

Safety and efficacy will also be measured.

Conditions

Interventions

DRUG

Osimertinib

The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.

Sponsors & Collaborators

Principal Investigators

  • Rafael Rosell, MD, PhD · Catalan Institute of Oncology, Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-02
Primary Completion
2018-12-31
Completion
2020-02-14

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02841579 on ClinicalTrials.gov