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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00527735
First received: September 7, 2007
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.


Condition Intervention Phase
Lung Cancer
Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Drug: Ipilimumab
Drug: Placebo
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC) [ Time Frame: Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months) ] [ Designated as safety issue: No ]
    irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.


Secondary Outcome Measures:
  • Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria [ Time Frame: Randomization date to date of progression or death (of censored, maximum reached: 13.6 months) ] [ Designated as safety issue: No ]
    By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.

  • Overall Survival in Participants With NSCLC [ Time Frame: Randomization date to date of death (of censored, maximum reached: 26.5 months) ] [ Designated as safety issue: No ]
    Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.

  • Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC [ Time Frame: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance ] [ Designated as safety issue: No ]
    mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of >=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.

  • Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC) [ Time Frame: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance ] [ Designated as safety issue: No ]
    irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.

  • Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC [ Time Frame: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months) ] [ Designated as safety issue: No ]
    irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.

  • Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC [ Time Frame: Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months) ] [ Designated as safety issue: No ]
    irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.

  • Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade [ Time Frame: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose) ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

  • Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade [ Time Frame: At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent ] [ Designated as safety issue: Yes ]
    CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.

  • irPFS in Participants With SCLC Per irRC [ Time Frame: Randomization date to date of irPD or death (maximum reached: 22 months) ] [ Designated as safety issue: No ]
    IRC performed TA.

  • Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade [ Time Frame: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent ] [ Designated as safety issue: Yes ]
    ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.

  • Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings [ Time Frame: At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent ] [ Designated as safety issue: Yes ]
    Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.

  • Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade [ Time Frame: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment ] [ Designated as safety issue: Yes ]
    ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Creatine (mg/dL) Grade 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.

  • Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline [ Time Frame: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment ] [ Designated as safety issue: No ]
    An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.

  • Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade [ Time Frame: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose) ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

  • Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade [ Time Frame: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment ] [ Designated as safety issue: Yes ]
    CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.

  • Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade [ Time Frame: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment ] [ Designated as safety issue: Yes ]
    ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.

  • Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade [ Time Frame: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment ] [ Designated as safety issue: Yes ]
    ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Gr 2 >1.5 to 2.0*ULN, Gr 3 >2.0 to 5.0*ULN, Gr 4 >5.0*ULN. Creatine (mg/dL) Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.

  • Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria [ Time Frame: Randomization date to date of progression or death (of censored, maximum reached: 22 months) ] [ Designated as safety issue: No ]
    By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.

  • Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings [ Time Frame: Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment ] [ Designated as safety issue: Yes ]
    Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.

  • Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline [ Time Frame: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment ] [ Designated as safety issue: No ]
    An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.

  • Overall Survival in Participants With SCLC [ Time Frame: Randomization date to date of death (of censored, maximum reached: 22 months) ] [ Designated as safety issue: No ]
    Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.


Enrollment: 334
Study Start Date: February 2008
Study Completion Date: December 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent) Drug: Ipilimumab
Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
Drug: Placebo
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
Drug: Paclitaxel
175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
Drug: Carboplatin
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.
Experimental: Ipilimumab/ placebo + paclitaxel + carboplatin (sequential) Drug: Ipilimumab
Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
Drug: Placebo
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
Drug: Paclitaxel
175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
Drug: Carboplatin
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.
Active Comparator: Ipilimumab placebo + paclitaxel + carboplatin Drug: Placebo
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
Drug: Paclitaxel
175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
Drug: Carboplatin
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer [SCLC])
  • Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria
  • Eastern Cooperative Oncology Group performance status of ≤1 at study entry
  • Accessible for treatment and follow-up

Exclusion Criteria:

  • Brain metastases
  • Malignant pleural effusion
  • Autoimmune disease
  • Motor neuropathy of autoimmune origin
  • SCLC-related paraneoplastic syndromes
  • Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)
  • Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.

    • Grade 2 peripheral neuropathy (motor or sensory)
  • Known HIV or hepatitis B or C infection
  • Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
  • Inadequate hematologic function defined by an absolute neutrophil count <1,500/mm^3, a platelet count <100,000/mm^3, or hemoglobin level <9 g/dL.
  • Inadequate hepatic function defined by a total bilirubin level >2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present.
  • Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN
  • Inadequate creatinine clearance defined as less than 50 mL/min.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology & Oncology Assoc. Llc
Birmingham, Alabama, United States, 35235
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
United States, California
Compassionate Cancer Care Medical Group
Corona, California, United States, 92879
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States, 92708
The Angeles Clinic & Research Institute, Inc
Los Angeles, California, United States, 90025
Oncology Care Medical Associates
Montebello, California, United States, 90640
Compassionate Cancer Care Medical Group
Riverside, California, United States, 92501
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, Florida
M D Anderson Cancer Center- Orlando
Orlando, Florida, United States, 32806
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
United States, Illinois
University Of Chicago Medical Center
Chicago, Illinois, United States, 60637
Local Institution
Park Ridge, Illinois, United States, 60068
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
United States, Maryland
The John R. Marsh Cancer Center
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
The Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Local Institution
New York, New York, United States, 10017
United States, North Carolina
Cmc-Northeast/ Northeast Oncology Associates
Concord, North Carolina, United States, 28025
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Hematology Oncology Consultants, Inc
Columbus, Ohio, United States, 43235
United States, Pennsylvania
St. Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
Guthrie Clinical Research
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Santee Hematology/Oncology
Sumter, South Carolina, United States, 29150
United States, Texas
Southwest Cancer Treatment And Research Center
Lubbock, Texas, United States, 79415
France
Local Institution
Belfort, France, 90016
Local Institution
Caen, France, 14076
Local Institution
Marseille Cedex 9, France, 13274
Local Institution
Rennes Cedex 9, France, 35033
Germany
Local Institution
Bochum, Germany, 44791
Local Institution
Coswig, Germany, 01640
Local Institution
Ebensfeld, Germany, 96250
Local Institution
Grosshansdorf, Germany, 22927
Local Institution
Halle (Saale), Germany, 06120
Local Institution
Hamburg, Germany, 21075
Local Institution
Koeln, Germany, 51109
Local Institution
Leipzig, Germany, 04103
Local Institution
Mainz, Germany, 55131
Local Institution
Muenchen, Germany, 81675
India
Local Institution
Hyderabad, Andhra Pradesh, India, 500082
Local Institution
Navrangpura, Ahmedabad, Gujarat, India, 380009
Local Institution
Manipal, Karnataka, India, 576104
Local Institution
Trivandrum, Kerala, India, 695011
Local Institution
Vellore, India, 632004
Italy
Local Institution
Genova, Italy, 16132
Local Institution
Siena, Italy, 53100
Local Institution
Torino, Italy, 10143
Poland
Local Institution
Gdansk, Poland, 80-952
Local Institution
Krakow, Poland, 31-826
Local Institution
Olsztyn, Poland, 10-513
Local Institution
Szczecin, Poland, 70-891
Russian Federation
Local Institution
Arkhangelsk, Russian Federation, 163045
Local Institution
Chelyabinsk, Russian Federation, 454087
Local Institution
Ivanovo, Russian Federation, 153013
Local Institution
Moscow, Russian Federation, 105077
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Moscow, Russian Federation, 125284
Local Institution
Pyatigorsk, Russian Federation, 357502
Local Institution
Saint-Petersburg, Russian Federation, 190005
Local Institution
Sochi, Russian Federation, 354057
Local Institution
St. Petersburg, Russian Federation, 194291
Local Institution
St. Petersburg, Russian Federation, 194044
Local Institution
St. Petersburg, Russian Federation, 198255
Local Institution
St. Petersburg, Russian Federation, 197022
Ukraine
Local Institution
Dnipropetrovsk, Ukraine, 49102
Local Institution
Donetsk, Ukraine, 83092
Local Institution
Kharkov, Ukraine, 46023
Local Institution
Lviv, Ukraine, 79031
Local Institution
Ternopol, Ukraine, 46023
Local Institution
Uzhgorod, Ukraine, 88014
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00527735     History of Changes
Other Study ID Numbers: CA184-041
Study First Received: September 7, 2007
Results First Received: February 23, 2012
Last Updated: June 11, 2012
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)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 29, 2014