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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01285609




Registration number
NCT01285609
Ethics application status
Date submitted
24/01/2011
Date registered
28/01/2011
Date last updated
18/06/2020

Titles & IDs
Public title
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
Scientific title
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2009-017396-19
Secondary ID [2] 0 0
CA184-104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer - Non Small Cell Squamous 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Placebo
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin

Experimental: Ipilimumab + Paclitaxel and Carboplatin - Ipilimumab + Active Chemo Backbone
Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)
Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses
Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

Placebo Comparator: Placebo + Paclitaxel and Carboplatin - Placebo + Active Chemo Backbone
Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)
Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses
Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses


Treatment: Drugs: Ipilimumab


Treatment: Drugs: Placebo


Treatment: Drugs: Paclitaxel


Treatment: Drugs: Carboplatin


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint - Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Timepoint [1] 0 0
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Secondary outcome [1] 0 0
Overall Survival (OS) in All Randomized Participants at Primary Endpoint - Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Timepoint [1] 0 0
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
Secondary outcome [2] 0 0
Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint - Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Timepoint [2] 0 0
Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.



- Non small cell lung cancer (NSCLC) - squamous cell

- Stage IV or recurrent NSCLC

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Brain Metastases

- Autoimmune diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Bedford Park
Recruitment hospital [2] 0 0
Local Institution - Box Hill
Recruitment hospital [3] 0 0
Local Institution - Frankston
Recruitment hospital [4] 0 0
Local Institution - Heidelberg
Recruitment hospital [5] 0 0
Local Institution - Wodonga
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Connecticut
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Florida
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Illinois
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Indiana
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Kentucky
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Michigan
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Missouri
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Virginia
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Wisconsin
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Santa Fe
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Graz
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Linz
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Salzburg
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Belgium
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Aalst
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Liege
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Sint Niklaas
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Yvoir
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Parana
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Paris
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Poitiers
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France
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Rennes Cedex 9
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France
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Toulouse Cedex 9
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Vandoeuvre-les-nancy
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Bad Berka
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Bochum
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Darmstadt
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Dresden
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Frankfurt Am Main
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Germany
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Gauting
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Germany
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Grosshandsdorf
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Germany
State/province [85] 0 0
Hamburg
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Germany
State/province [86] 0 0
Heidelberg
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Germany
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Kassel
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Germany
State/province [88] 0 0
Lubeck
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Germany
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Mainz
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Germany
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Muenchen
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Germany
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Neumunster
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Germany
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Nuernberg
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Germany
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Regensburg
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Germany
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Tuebingen
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Germany
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Ulm
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Germany
State/province [96] 0 0
Villingen-Schwenningen
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Hong Kong
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Hong Kong
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Hong Kong
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Deszk
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Gyula
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Matrahaza
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Nyiregyhaza
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Pecs
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Hungary
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Sopron
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Hungary
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Szekesfehervar
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Hungary
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Szolnok
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Dublin
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Ireland
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Galway
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Israel
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
State/province [114] 0 0
Nahariya
Country [115] 0 0
Israel
State/province [115] 0 0
Petah-Tikva
Country [116] 0 0
Israel
State/province [116] 0 0
Rehovot
Country [117] 0 0
Israel
State/province [117] 0 0
Tel Aviv
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Israel
State/province [118] 0 0
Tel-aviv
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Israel
State/province [119] 0 0
Tel-hashomer
Country [120] 0 0
Israel
State/province [120] 0 0
Zerifin
Country [121] 0 0
Italy
State/province [121] 0 0
Benevento
Country [122] 0 0
Italy
State/province [122] 0 0
Bologna
Country [123] 0 0
Italy
State/province [123] 0 0
Lido Di Camaiore
Country [124] 0 0
Italy
State/province [124] 0 0
Lucca
Country [125] 0 0
Italy
State/province [125] 0 0
Monza
Country [126] 0 0
Italy
State/province [126] 0 0
Padova
Country [127] 0 0
Italy
State/province [127] 0 0
Perugia
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Italy
State/province [128] 0 0
Siena
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Italy
State/province [129] 0 0
Sondrio
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Italy
State/province [130] 0 0
Terni
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Italy
State/province [131] 0 0
Treviglio
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Japan
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Japan
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Tokyo
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Yamaguchi
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Japan
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Japan
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Fukuoka
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Japan
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St. Petersburg
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Tula
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Singapore
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Vizcaya
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Spain
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Avila
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Spain
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Benidorm-alicante
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Spain
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Castellon
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Spain
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Madrid
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Manresa
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Ourense
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Spain
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Valencia
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Lund
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Country [216] 0 0
Switzerland
State/province [216] 0 0
Winterthur
Country [217] 0 0
Taiwan
State/province [217] 0 0
Changhua City
Country [218] 0 0
Taiwan
State/province [218] 0 0
Chiayi
Country [219] 0 0
Taiwan
State/province [219] 0 0
Kaohsiung County
Country [220] 0 0
Taiwan
State/province [220] 0 0
Taichung
Country [221] 0 0
Taiwan
State/province [221] 0 0
Taipei City
Country [222] 0 0
Taiwan
State/province [222] 0 0
Taipei
Country [223] 0 0
Thailand
State/province [223] 0 0
Tungpayathai
Country [224] 0 0
Thailand
State/province [224] 0 0
Bangkok
Country [225] 0 0
Thailand
State/province [225] 0 0
Chiang Mai
Country [226] 0 0
Thailand
State/province [226] 0 0
Songkhla
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Angus/forfarshire
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Cornwall
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Hampshire
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Nottingham
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin
will extend the lives of patients with squamous only non small cell lung cancer more than
placebo plus Paclitaxel and Carboplatin.
Trial website
https://clinicaltrials.gov/show/NCT01285609
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications