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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
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
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
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
Sex
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
16/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2017
Sample size
Target
Accrual to date
Final
1289
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
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Herlev
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Hillerod
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Naestved
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Odense
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France
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Gauting
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Grosshandsdorf
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Germany
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Hamburg
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Germany
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Heidelberg
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Kassel
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Lubeck
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Germany
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Germany
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Ulm
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Germany
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Villingen-Schwenningen
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Deszk
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Israel
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Israel
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Petah-Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv
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Israel
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Tel-aviv
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Israel
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Tel-hashomer
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Israel
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Zerifin
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Benevento
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Italy
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Bologna
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Italy
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Lido Di Camaiore
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Italy
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Lucca
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Italy
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Monza
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Italy
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Padova
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Italy
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Perugia
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Italy
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Siena
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Italy
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Sondrio
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Italy
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Terni
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Italy
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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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Miyagi
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Elblag
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Avila
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Castellon
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Manresa
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Ourense
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Spain
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Valencia
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Gothenburg
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Lund
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Stockholm
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Umea
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Basel
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Switzerland
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Winterthur
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Taiwan
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Changhua City
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Taiwan
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Chiayi
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Taiwan
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Kaohsiung County
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Songkhla
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United Kingdom
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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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01285609