A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.

Roche

Status and phase

Completed

Phase 2

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Treatments

Drug: Gemcitabine

Drug: Erlotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00518011

ML20063

Details and patient eligibility

About

This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, >=18 years of age;
non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
ECOG PS 2;
adequate organ function.

Exclusion criteria

prior chemotherapy or systemic anti-tumor therapy;
hypersensitivity to erlotinib;
any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

17 participants in 2 patient groups

Erlotinib + Gemcitabine

Experimental group

Description:

Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.

Treatment:

Drug: Gemcitabine

Drug: Erlotinib

Gemcitabine

Active Comparator group

Description:

Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.

Treatment:

Drug: Gemcitabine