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

Roche

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer Metastatic

Treatments: Drug: Erlotinib; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701558

2007-002135-83

ML20951

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Erlotinib + Gemcitabine

Experimental group

Description:

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.

Treatment:

Drug: Gemcitabine

Drug: Erlotinib