Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC
Last updated on April 2022Recruitment
- 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