Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
- Estimated Enrollment
- 304
Inclusion Criteria
- Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
- 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)
- ECOG karnofsky performance 0~3, life expectancy is greater than 12 weeks;
- Measurable disease by RECIST criteria;
- Histological diagnosis of NSCLC with phase IIIB or IV disease;
- Male or female patients >=18 years of age;
- Patients must be accessible for treatment and follow-up;
- Never received anti-tumor therapies for the advanced stage;
- Never used EGFR inhibitors;
Exclusion Criteria
- Patients having other factors that preventing researchers from enrollment them.
- Pregnant or lactating women;
- Previously used EGFR inhibitors
- ...
- 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;
- Non-measurable lesions
- 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
- Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
- 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)
- ECOG karnofsky performance 0~3, life expectancy is greater than 12 weeks;
- Measurable disease by RECIST criteria;
- Histological diagnosis of NSCLC with phase IIIB or IV disease;
- Male or female patients >=18 years of age;
- Patients must be accessible for treatment and follow-up;
- Never received anti-tumor therapies for the advanced stage;
- Never used EGFR inhibitors;
Exclusion Criteria
- Patients having other factors that preventing researchers from enrollment them.
- Pregnant or lactating women;
- Previously used EGFR inhibitors
- ...
- 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;
- Non-measurable lesions
- Allergic to erlotinib;
Tracking Information
- NCT #
- NCT02140333
- Collaborators
- Not Provided
- Investigators
- Not Provided