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

Purpose

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.

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

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Docetaxel Pemetrexed disodium Pemetrexed Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	An Open-Label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-Small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-Based Chemotherapy

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PFS, time to progression, objective response, duration of response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	650
Study Start Date:	March 2006
Estimated Study Completion Date:	August 2014

Arms	Assigned Interventions
1: Experimental	Drug: erlotinib [Tarceva] 150mg po daily
2: Active Comparator	Drug: Alimta or Taxotere 500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)

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 or recurrent or metastatic NSCLC;
measurable disease;
disease progression during 1-4 cycles of platinum-based chemotherapy.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556322

Contacts


Contact: Please reference Study ID Number: PDO_BO18602	973-235-5000

Contact: or	800-526-6367 (FOR US ONLY)

Show 110 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:	BO18602
First Received:	November 9, 2007
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00556322
Health Authority:	Slovenia: Ministry of Health

Study placed in the following topic categories:

Thoracic Neoplasms

Erlotinib

Non-small cell lung cancer

Disease Progression

Recurrence

Carcinoma

Folic Acid

Docetaxel

Pemetrexed

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites

Respiratory Tract Neoplasms

Neoplasms by Histologic Type

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Enzyme Inhibitors

Folic Acid Antagonists

Protein Kinase Inhibitors

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00556322