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Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours

NCT02094261 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-11-06

Study results available
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Summary

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

AZD9291

Once daily tablet 80 mg

Sponsors & Collaborators

Principal Investigators

  • Glenwood Goss, MD · 501 Smyth Road, Ottawa, Canada

  • Tetsuya Mitsudomi, MD · Kinki University Hospital, Faculty of Medicine, Osaka, Japan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-20
Primary Completion
2015-05-01
Completion
2023-11-07

Countries

  • United States
  • Canada
  • Hong Kong
  • Italy
  • Japan
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT02094261 on ClinicalTrials.gov