Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
304

Inclusion Criteria

Never used EGFR inhibitors;
Male or female patients >=18 years of age;
Patients must be accessible for treatment and follow-up;
...
Never used EGFR inhibitors;
Male or female patients >=18 years of age;
Patients must be accessible for treatment and follow-up;
Histological diagnosis of NSCLC with phase IIIB or IV disease;
ECOG karnofsky performance 0~3, life expectancy is greater than 12 weeks;
Measurable disease by RECIST criteria;
Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
Never received anti-tumor therapies for the advanced stage;

Exclusion Criteria

Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
Non-measurable lesions
Allergic to erlotinib;
...
Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
Non-measurable lesions
Allergic to erlotinib;
Patients having other factors that preventing researchers from enrollment them.
Previously used EGFR inhibitors
Pregnant or lactating women;

Summary

Conditions
  • EGFR Mutation
  • NSCLC
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Inclusion Criteria

Never used EGFR inhibitors;
Male or female patients >=18 years of age;
Patients must be accessible for treatment and follow-up;
...
Never used EGFR inhibitors;
Male or female patients >=18 years of age;
Patients must be accessible for treatment and follow-up;
Histological diagnosis of NSCLC with phase IIIB or IV disease;
ECOG karnofsky performance 0~3, life expectancy is greater than 12 weeks;
Measurable disease by RECIST criteria;
Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
Never received anti-tumor therapies for the advanced stage;

Exclusion Criteria

Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
Non-measurable lesions
Allergic to erlotinib;
...
Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
Non-measurable lesions
Allergic to erlotinib;
Patients having other factors that preventing researchers from enrollment them.
Previously used EGFR inhibitors
Pregnant or lactating women;

Tracking Information

NCT #
NCT02140333
Collaborators
Not Provided
Investigators
Not Provided
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