Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

NSCLC Clinical Trial

Official title:

Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer

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

• EGFR Mutation
• NSCLC

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