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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518011
• Other study ID #: ML20063
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2007
• Last updated: November 2, 2015
• Start date: August 2007
• Est. completion date: July 2009

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Cancer Trials Australia, Royal Melbourne Hospital
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Gemcitabine
As prescribed
• erlotinib [Tarceva]
150mg po daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		Event driven	No
Secondary	Overall response rate, disease control rate, duration of response, overall survival.		Event driven	No
Secondary	AEs, SAEs, vital signs.		Throughout study	No