A Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00449033

Purpose

Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)

Condition	Intervention	Phase
NSCLC Carcinoma, Non-Small-Cell Lung	Drug: Nexavar (Sorafenib, BAY43-9006) plus gemcitabine and cisplatin Drug: placebo plus gemcitabine and cisplatin	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Randomized, Double-Blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by Bayer:

Primary Outcome Measures:

Overall Survival in patients treated with gemcitabine, cisplatin and sorafenib to PFS in patients treated with gemcitabine, cisplatin and placebo [ Time Frame: After 618 death events ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse event collection [ Time Frame: After 618 death events ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: After 526 death events ] [ Designated as safety issue: No ]
Patient reported outcomes [ Time Frame: After 618 death events ] [ Designated as safety issue: No ]
Evaluation of biomarkers [ Time Frame: After 618 death events ] [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	February 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Nexavar (Sorafenib, BAY43-9006) plus gemcitabine and cisplatin Multikinase inhibitor plus chemotherapy: Gemcitabine 1250 mg/m² IV, Cisplatin 75 mg/m² IV , Sorafenib 400 mg po bid
Arm 2: Placebo Comparator	Drug: placebo plus gemcitabine and cisplatin Chemotherapy: Gemcitabine 1250 mg/m² IV, Cisplatin 75 mg/m² IV, Placebo 2 tablets po bid

Eligibility

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

Criteria

Inclusion Criteria:

Stage IIIB (with pericardial or pleural effusion) or Stage IV NSCLC squamous or non-squamous histology
ECOG Performance status 0 or 1

Exclusion Criteria:

Prior systemic therapy for NSCLC
Brain metastases
Uncontrolled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449033

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Show 120 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	12006, EudraCT 2006-002688-26
Study First Received:	March 16, 2007
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00449033
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Non-Small Cell Lung Cancer (NSCLC)
Cancer

Study placed in the following topic categories:

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

Gemcitabine
Sorafenib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009