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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02140333
Other study ID # FAHG20130819
Secondary ID GZMC201301
Status Recruiting
Phase Phase 3
First received October 5, 2013
Last updated February 11, 2015
Start date August 2013
Est. completion date December 2018

Study information

Verified date February 2015
Source The First Affiliated Hospital of Guangzhou Medical University
Contact jianxing He, PhD
Phone 86-20-83062821
Email drjianxing.he@gmail.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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 similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date December 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Erlotinib
100mg vs. 150mg

Locations

Country Name City State
China Guangzhou medical university Guanzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Overall survival 3 year after the initial dose No
Other Adverse events 1 year Yes
Primary Progression free survival 2 years after the initial dose No
Secondary The objective response rate Patients will be followed for an expected average of 6 months No
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