Clinical trial NCT00518011: A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
Official title: A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-08-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Up to 2 years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Up to 2 years
measure: Disease Control Rate
timeFrame: Up to 2 years
measure: Duration of Response
timeFrame: Up to 2 years
measure: Overall Survival
timeFrame: Up to 2 years
measure: Mean Change in Pulse Rate From Baseline
timeFrame: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
measure: Mean Change in Blood Pressure From Baseline
timeFrame: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
measure: Mean Change in Body Temperature From Baseline
timeFrame: Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)
Other outcomes:
Locations:
city: Auchenflower
country: Australia
city: Chermside
country: Australia
city: Footscray
country: Australia
city: Greenslopes
country: Australia
city: Lismore
country: Australia
city: Melbourne
country: Australia
city: Melbourne
country: Australia
city: Parkville
country: Australia
city: Randwick
country: Australia
city: Richmond
country: Australia
city: St. Leonards
country: Australia
city: Sydney
country: Australia
city: Wodonga
country: Australia
city: Wollongong
country: Australia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: