Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

Guangzhou Medical University

Status and phase: Unknown; Phase 3

Conditions: EGFR Mutation; NSCLC

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02140333

GZMC201301

FAHG20130819

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

220 participants in 2 patient groups

Erlotinib 100mg

Experimental group

Description:

Erlotinib 100mg

Treatment:

Drug: Erlotinib

Erlotinib 150mg

Active Comparator group

Description:

Erlotinib 150mg

Treatment:

Drug: Erlotinib