A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

Roche

Status and phase: Completed; Phase 4

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: erlotinib [Tarceva]; Drug: vinorelbine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196078

ML20322

Details and patient eligibility

About

This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.

Enrollment: 114 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >=70 years of age
• Non-small cell lung cancer
• Naive to prior chemotherapy or specific immunotherapy
• Presence of at least 1 measurable lesion

Exclusion criteria

• Active non-controlled infection or disease
• CNS metastases
• Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: erlotinib [Tarceva]

2

Active Comparator group

Treatment:

Drug: vinorelbine