A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-12-31

Brief Summary

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This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer Metastatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erlotinib + Gemcitabine

Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

150 mg po daily

Gemcitabine

Intervention Type DRUG

1000 mg/m\^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles

Interventions

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Erlotinib

150 mg po daily

Intervention Type DRUG

Gemcitabine

1000 mg/m\^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles

Intervention Type DRUG

Other Intervention Names

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Tarceva

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
* no previous systemic chemotherapy, radiation therapy or immunotherapy;
* Eastern Cooperative Oncology Group (ECOG) \>=2.

Exclusion Criteria

* prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
* active, non-controlled systemic disease;
* any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No