Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02140333

Enrollment

220

Registered

2014-05-16

Start date

2013-08-31

Completion date

2018-12-31

Last updated

2015-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR Mutation, NSCLC

Keywords

erlotinib, EGFR mutation

Brief 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.

Detailed 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.

Interventions

DRUGErlotinib

100mg vs. 150mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression free survival	2 years after the initial dose

Secondary

Measure	Time frame
The objective response rate	Patients will be followed for an expected average of 6 months

Other

Measure	Time frame
Overall survival	3 year after the initial dose
Adverse events	1 year

Countries

China

Contacts

Primary Contactjianxing He, PhD

drjianxing.he@gmail.com86-20-83062821

Backup Contactyalei zhang, Dr.

yayazhang2004@163.com86-20-83062821

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026