Lung Cancer Clinical Trial; Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, January 2009
Sponsored by: Bristol-Myers Squibb

Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00527735

Purpose
The purpose of the study is to see if ipilimumab given with paclitaxel/carboplatin will have clinical benefit when compared to paclitaxel/carboplatin alone in previously untreated patients with lung cancer

Condition Intervention Phase
Lung Cancer
Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Drug: Ipilimumab and Taxol and Paraplatin (concurrent)
Drug: Ipilimumab and Taxol and Paraplatin (sequential)
Drug: Ipilimumab placebo and Taxol and Paraplatin
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Paclitaxel Ipilimumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
EORTC-QLQ-30 questionnaire [ Time Frame: completed at every visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: February 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental Drug: Ipilimumab and Taxol and Paraplatin (concurrent)
Intravenous Solution, Intravenous, Ipilimumab - 10mg/kg (4 active + 2 placebo), Taxol - 175 mg/m2, Paraplatin - AUC = 6, Every 3 weeks, up to 4 active doses of ipilimumab and up to 6 doses of chemo, Until disease progression, unacceptable toxicity or withdrawal of consent
B: Experimental Drug: Ipilimumab and Taxol and Paraplatin (sequential)
Intravenous Solution, Intravenous, Ipilimumab - 10mg/kg ( 2 Placebo + 4 active), Taxol - 175 mg/m2, Paraplatin - AUC = 6, every 3 weeks, up to 4 active doses of ipilimumab and up to 6 doses of chemo, Until disease progression, unacceptable toxicity or withdrawal of consent
C: Active Comparator Drug: Ipilimumab placebo and Taxol and Paraplatin
Intravenous Solution, Intravenous, Ipilimumab - 10mg/kg (all placebo), Taxol - 175 mg/m2, Paraplatin - AUC = 6, every 3 weeks, up to 6 placebo doses of ipilimumab and up to 6 doses of chemo, Until disease progression, unacceptable toxicity or withdrawal of consent

Eligibility

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

Criteria
Inclusion Criteria:

Documented NSCLC or SCLC
ECOG of 0 or 1
Exclusion Criteria:

Brain metastases
Autoimmune disease
Known HIV, Hep B or Hep C infection
Peripheral neuropathy ¡Ý grade 2
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527735

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 91 Study Locations

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CA184-041
Study First Received: September 7, 2007
Last Updated: February 9, 2009
ClinicalTrials.gov Identifier: NCT00527735 [history]
Health Authority: United States: Food and Drug Administration; France: Ministry of Health; India: Drugs Controller General of India; United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
Non Small Cell Lung Cancer (NSCLC)
Small Cell Lung Cancer (SCLC)

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Carcinoma, Neuroendocrine
Carboplatin
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Site
Neoplasms, Nerve Tissue
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 10, 2009

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