Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
304

Inclusion Criteria

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

Exclusion Criteria

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

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

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

Exclusion Criteria

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

Tracking Information

NCT #
NCT02140333
Collaborators
Not Provided
Investigators
Not Provided