Clinical Trials /

Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

NCT02140333

Description:

The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC
  • Official Title: Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: FAHG20130819
  • SECONDARY ID: GZMC201301
  • NCT ID: NCT02140333

Conditions

  • NSCLC
  • EGFR Mutation

Interventions

DrugSynonymsArms
ErlotinibtarcevaErlotinib 100mg

Purpose

The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.

Detailed Description

      In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR
      mutation, but reducing dose occurring in some patients because of the drug related
      side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation
      whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with
      standad dose (150mg) Erlotinib.
    

Trial Arms

NameTypeDescriptionInterventions
Erlotinib 100mgExperimentalErlotinib 100mg
  • Erlotinib
Erlotinib 150mgActive ComparatorErlotinib 150mg
  • Erlotinib

Eligibility Criteria

        Inclusion Criteria:

          1. Histological diagnosis of NSCLC with phase IIIB or IV disease;

          2. Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection
             methods:ARMS-PCR, sequence method)

          3. Never received anti-tumor therapies for the advanced stage;

          4. Never used EGFR inhibitors;

          5. Measurable disease by RECIST criteria;

          6. Male or female patients >=18 years of age;

          7. ECOG karnofsky performance 0~3, life expectancy is greater than 12 weeks;

          8. Patients must be accessible for treatment and follow-up;

        Exclusion Criteria:

          1. Previously used EGFR inhibitors

          2. Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;

          3. Allergic to erlotinib;

          4. Non-measurable lesions

          5. Pregnant or lactating women;

          6. Patients having other factors that preventing researchers from enrollment them.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival
Time Frame:2 years after the initial dose
Safety Issue:
Description:

Secondary Outcome Measures

Measure:The objective response rate
Time Frame:Patients will be followed for an expected average of 6 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:The First Affiliated Hospital of Guangzhou Medical University

Trial Keywords

  • erlotinib
  • EGFR mutation

Last Updated

February 11, 2015