A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer

Roche

Status and phase: Terminated; Phase 2

Conditions: Non-Small Cell Lung Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00940875

ML22429

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ECOG performance status of 2, with advanced non-small cell lung cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=70 years of age or with ECOG PS of 2;
• advanced (stage IIIB or IV)non-small cell lung cancer;
• no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis targeted drugs.

Exclusion criteria

• active brain metastasis or spinal cord suppression;
• unstable systemic disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: gemcitabine

Drug: gemcitabine

Drug: erlotinib [Tarceva]

2

Active Comparator group

Treatment:

Drug: gemcitabine

Drug: gemcitabine