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Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations

NCT01024413 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2017-03-01

No results posted yet for this study

Summary

This is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).

Conditions

  • Thoracic Neoplasms

Interventions

DRUG

erlotinib

study arm.erlotinib 150 mg oral till disease progression

DRUG

gefitinib

study arm.gefitinib 250 mg oral till disease progression

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Chinese Society of Lung Cancer

    lead OTHER

Principal Investigators

  • Wu Yi Long, MD · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • China

Study Locations

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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 NCT01024413 on ClinicalTrials.gov