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Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

16 giugno 2020 aggiornato da: Bristol-Myers Squibb

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)

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1289

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Cordoba, Argentina, X5006HBF
        • Local Institution
      • Cordoba, Argentina, X5006IKK
        • Local Institution
      • Mendoza, Argentina, M5500AYB
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      • Santa Fe, Argentina, S3000FFU
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    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, B1878DVB
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    • Santa FE
      • Rosario, Santa FE, Argentina, S2000DSV
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    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, 4000
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  • Australia
    • South Australia
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    • Victoria
      • Box Hill, Victoria, Australia, 3128
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      • Frankston, Victoria, Australia, 3199
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      • Heidelberg, Victoria, Australia, 3084
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      • Wodonga, Victoria, Australia, 3690
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  • Austria
      • Graz, Austria, 8036
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      • Linz, Austria, 4020
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      • Salzburg, Austria, 5020
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  • Belgio
      • Aalst, Belgio, 9300
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      • Liege, Belgio, 4000
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      • Yvoir, Belgio, 5530
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      • Goyang-si, Gyeonggi-do, Corea, Repubblica di, 410-769
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    • Kangnam-gu
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  • Giappone
      • Akashi, Hyogo, Giappone, 6738558
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      • Fukuoka, Giappone, 8128582
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      • Matsuyama, Ehime, Giappone, 791-0280
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    • Okayama
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    • Osaka
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    • Tokyo
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    • Yamaguchi
      • Ube-shi, Yamaguchi, Giappone, 7550241
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      • Jerusalem, Israele, 91120
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      • Tel Aviv, Israele, 64239
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      • Tel-aviv, Israele, 69710
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      • Tel-hashomer, Israele, 52621
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      • Zerifin, Israele, 70300
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  • Italia
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      • Lido Di Camaiore, Italia, 55041
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      • Treviglio, Italia, 24047
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  • Messico
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    • Nuevo LEON
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  • Olanda
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    • Angus/forfarshire
      • Dundee, Angus/forfarshire, Regno Unito, DD1 9SY
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    • Cornwall
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    • Florida
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      • Jacksonville, Florida, Stati Uniti, 32256
        • Integrated Community Oncology Network
    • 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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    • New Hampshire
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    • New York
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    • North Carolina
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        • Durham Va Medical Center (111g)
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    • Ohio
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    • Oklahoma
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    • Oregon
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    • Pennsylvania
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    • Tennessee
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Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Non small cell lung cancer (NSCLC) - squamous cell
  • Stage IV or recurrent NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Brain Metastases
  • Autoimmune diseases

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: Ipilimumab
Altri nomi:
  • BMS-734016
Droga: Carboplatino
Altri nomi:
  • Paraplatino®
Droga: Paclitaxel
Altri nomi:
  • Taxolo®
Comparatore placebo: 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
Droga: Placebo
Droga: Carboplatino
Altri nomi:
  • Paraplatino®
Droga: Paclitaxel
Altri nomi:
  • Taxolo®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Lasso di tempo: 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)
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.
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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Lasso di tempo: 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)
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.
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)
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
Lasso di tempo: 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)
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.
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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 gennaio 2011

Completamento primario (Effettivo)

9 giugno 2015

Completamento dello studio (Effettivo)

22 agosto 2017

Date di iscrizione allo studio

Primo inviato

24 gennaio 2011

Primo inviato che soddisfa i criteri di controllo qualità

27 gennaio 2011

Primo Inserito (Stima)

28 gennaio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 giugno 2020

Ultimo verificato

1 giugno 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CA184-104
  • 2009-017396-19 (Numero EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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