Study of BMS-936558 Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) - Full Text View

Purpose

The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

Condition	Intervention	Phase
Squamous Cell Non-small Cell Lung Cancer	Biological: BMS-936558 Drug: Docetaxel	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Randomized Phase III Trial of BMS-936558 Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Objective Response Rate [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Objective Response Rate is defined as the number of subjects with a Best overall response (BOR) of CR or PR divided by the number of randomized subjects
Overall Survival [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Overall Survival is defined as the time from randomization to the date of death

Secondary Outcome Measures:

The progression-free survival (PFS) of BMS-936558 versus docetaxel [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Clinical benefit in terms of Objective response rate (ORR) and Overall survival (OS) of BMS-936558 versus docetaxel, in PD-L1 + versus PD-L1- protein expression subgroups [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Duration of objective response in BMS-936558 and docetaxel groups [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Duration of objective response (DOOR) is defined as the time between the date of first response to the date of the first documented tumor progression or death due to any cause
Time to objective response in BMS-936558 and docetaxel groups [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Time to objective response (TTOR) is defined as the time from randomization to the date of the first documented Complete response (CR) or Partial response (PR)
Proportion of subjects exhibiting disease-related symptom progression, as measured by Lung Cancer Symptom Scale (LCSS), in BMS-936558 and docetaxel groups [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	264
Study Start Date:	October 2012
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A- BMS-936558	Biological: BMS-936558 Solution for injection, Intravenous (IV), 3 mg/kg, Every 2 weeks, Until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Active Comparator: Arm B- Docetaxel	Drug: Docetaxel Concentrate for solution for infusion, IV, 75 mg/m2, Every 3 weeks, Until documented disease progression,discontinuation due to toxicity, withdrawal of consent or the study ends Other Name: Taxotere®

Eligibility

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

Criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

Men & women ≥ 18 years of age
Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent disease following radiation therapy or surgical resection
Disease recurrence or progression during/after one prior platinum-containing chemotherapy regimen for advanced or metastatic disease
Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
An formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient

Exclusion Criteria:

Subjects with active Central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10mg daily prednisone (or equivalent)
Subjects with carcinomatous meningitis
Subjects with active, known or suspected autoimmune disease, or subjects with interstitial lung disease
Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Prior treatment on the first line study CA184104 first line NSCLC study
Prior treatment with docetaxel
Treatment with any investigational agent within 28 days of first administration of study treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642004

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 97 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01642004 History of Changes
Other Study ID Numbers:	CA209-017, 2011-004792-36
Study First Received:	July 9, 2012
Last Updated:	May 16, 2013
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Canada: Health Canada Chile: Instituto de Salud Publica de Chile Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Italy: Ministry of Health Mexico: Federal Commission for Sanitary Risks Protection Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Norway: Data Protection Authority Norway: Directorate of Health Peru: Instituto Nacional de Salud Poland: National Institute of Medicines Romania: National Medicines Agency Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Turkey: Ministry of Health United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013