A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00556712

Purpose

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: erlotinib [Tarceva] Drug: Placebo	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-Based Chemotherapy on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Not Experienced Disease Progression or Unacc

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival, time to progression [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Estimated Enrollment:	850
Study Start Date:	January 2006
Estimated Study Completion Date:	February 2009

Arms	Assigned Interventions
1: Experimental	Drug: erlotinib [Tarceva] 150mg po daily
2: Placebo Comparator	Drug: Placebo po daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients >=18 years of age;
histologically documented, locally advanced , recurrent or metastatic NSCLC;
measurable disease;
no disease progression after 4 cycles of platinum-based chemotherapy.

Exclusion Criteria:

unstable systemic disease;
any other malignancies in the last 5 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556712

Show 130 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BO18192
Study First Received:	November 9, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00556712
Health Authority:	Russia: Ministry of Health

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Disease Progression
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Site

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009