Erlotinib Intercalated With Chemotherapy Versus Erlotinib as First Line Treatment in Stage IIIB/IV NSCLC Patients With EGFR Mutation

Xinjiang Medical University

Status and phase: Unknown; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: gemcitabine; cisplatin or carboplatin; erlotinib; Drug: erlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02001896

XJTHLC001

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of treatment with erlotinib intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease progression, and the target sample size is 60 individuals.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;advanced (stage IIIB/IV)non-small cell lung cancer;measurable disease;ECOG Performance Status 0-2.

Exclusion criteria

• prior exposure to agents directed at the HER axis;prior chemotherapy or systemic anti-tumor therapy after advanced disease;unstable systemic disease; any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

erlotinib combine with chemotherapy

Experimental group

Description:

Drug: gemcitabine 1000mg/m2 iv on days 1 of each 4 week cycle for 6 cycles Drug: Platinum chemotherapy (cisplatin or carboplatin) cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles Drug: Erlotinib\[Tarceva\] po on days 15-28 of each 4 week cycle until disease progression

Treatment:

Drug: gemcitabine; cisplatin or carboplatin; erlotinib

erlotinib along

Active Comparator group

Description:

Drug: erlotinib \[Tarceva\] 150mg/day po until disease progression

Treatment:

Drug: erlotinib