Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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NSCLC EGFR Mutation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erlotinib 100mg

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

100mg vs. 150mg

Erlotinib 150mg

Group Type ACTIVE_COMPARATOR

Erlotinib

Intervention Type DRUG

100mg vs. 150mg

Interventions

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Erlotinib

100mg vs. 150mg

Intervention Type DRUG

Other Intervention Names

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tarceva

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No