A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Erlotinib; Drug: Standard platinum-based chemotherapy; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00531960

BO20571

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• advanced (stage IIIb and IV) non-small cell lung cancer;
• measurable disease;
• ECOG PS 0-1.

Exclusion criteria

• prior chemotherapy or treatment with another systemic anti-cancer agent;
• radiotherapy within 4 weeks prior to first dose of study treatment;
• CNS metastases;
• other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Bevacizumab, Chemotherapy

Active Comparator group

Description:

Participants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcitabine, 1250 mg/ square meter (m\^2), IV, on Days 1 and 8 of Cycles 1 through 4 or 6, and cisplatin 80 mg/m\^2, IV, on Day 1 of Cycles 1 through 4 or 6; or paclitaxel, 200 mg/m\^2, IV, and carboplatin area under the curve (AUC) 6 mg/ milliliter (ml) multiplied by (\*) minute (min) on Day 1 of Cycles 1 through 4 or 6. The chemotherapy regimen and number of cycles was up to the discretion of the investigator.

Treatment:

Drug: Bevacizumab

Drug: Standard platinum-based chemotherapy

Bevacizumab, Erlotinib

Experimental group

Description:

Participants received bevacizumab, 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib, 150 mg, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.

Treatment:

Drug: Bevacizumab

Drug: Erlotinib