Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Treatments: Erlotinib Hydrochloride

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.