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A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)

23 luglio 2015 aggiornato da: Hoffmann-La Roche

A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

315

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

  • Cina
      • Beijing, Cina, 100071
      • Changchun, Cina, 130012
      • Chengdu, Cina, 610041
      • Fuzhou, Cina, 350014
      • Guangzhou, Cina, 510030
      • Nanjing, Cina, 210009
      • Nanning, Cina, 530021
      • Shanghai, Cina, 200433
      • Shanghai, Cina, 200030
      • Shenyang, Cina, 110001
      • Tianjin, Cina, 300060
      • Wuhan, Cina, 430030
  • Danimarca
      • Hillerod, Danimarca, 3400
      • København, Danimarca, 2100
      • Naestved, Danimarca, 4700
      • Roskilde, Danimarca, 4000
  • Egitto
      • Cairo, Egitto, 11796
      • Cairo, Egitto
  • Francia
      • Caen, Francia, 14076
      • Limoges, Francia, 87042
      • Marseille, Francia, 13915
      • Paris, Francia, 75014
      • Paris, Francia, 75908
      • Paris, Francia, 75674
      • Pontoise, Francia, 95300
  • Germania
      • Berlin, Germania, 13125
      • Berlin, Germania, 14165
      • Essen, Germania, 45122
      • Gauting, Germania, 82131
      • Grosshansdorf, Germania, 22927
      • Hannover, Germania, 30625
      • Hannover, Germania, 30659
      • Immenhausen, Germania, 34376
      • Lostau, Germania, 39291
      • München, Germania, 81925
      • Nürnberg, Germania, 90419
      • Rheine, Germania, 48431
      • Villingen-Schwenningen, Germania, 78052
      • Wuerselen, Germania, 52146
      • Wuppertal, Germania, 42283
  • Olanda
      • Amsterdam, Olanda, 1007 MB
      • Breda, Olanda, 4818 CK
      • Nieuwegein, Olanda, 3435 CM
      • Zwolle, Olanda, 8011 JW
  • Spagna
      • Barcelona, Spagna, 08035
      • Barcelona, Spagna, 08041
      • Madrid, Spagna, 28040
      • Madrid, Spagna, 28041
      • Malaga, Spagna, 29010
      • Sevilla, Spagna, 41013
      • Valencia, Spagna, 46009
    • Barcelona
      • Sabadell, Barcelona, Barcelona, Spagna, 08208
  • Svizzera
      • Baden, Svizzera, 5404
      • Basel, Svizzera, 4031
      • Bern, Svizzera, 3011
      • Fribourg, Svizzera, 1708
  • Tacchino
      • Ankara, Tacchino, 06200
      • Ankara, Tacchino, 06000
      • Eskisehir, Tacchino, 26480
      • Gaziantep, Tacchino, 27310
      • Izmir, Tacchino, 35340
      • Izmir, Tacchino, 35110
      • Konya, Tacchino, 42050

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

Inclusion Criteria:

  • Adult patients aged ≥18 years
  • inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
  • Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy ≥12 weeks
  • Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study

Exclusion Criteria:

  • Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)
  • Radiotherapy within 28 days prior to enrollment
  • Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)

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: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
Droga: Erlotinib [Tarceva]
Single daily oral dose
Altri nomi:
  • Tarceva
Sperimentale: Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
Droga: Erlotinib [Tarceva]
Single daily oral dose
Altri nomi:
  • Tarceva

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-Free Survival (PFS)
Lasso di tempo: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
Progression-Free Survival (PFS) at the End of Study
Lasso di tempo: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
OS defined as the time from randomization to the date of death due to any cause.
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Overall Response Rate (ORR)
Lasso di tempo: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Disease Control Rate (DCR)
Lasso di tempo: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Time to Progression (TTP)
Lasso di tempo: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Number of Participants With Adverse Events (AEs) at the End of the Study
Lasso di tempo: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)

An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.

A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death.
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
Overall Survival (OS) at the End of Study
Lasso di tempo: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
OS defined as the time from randomization to the date of death due to any cause.
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)

Collaboratori e investigatori

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

Sponsor

Hoffmann-La Roche

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

1 ottobre 2010

Completamento primario (Effettivo)

1 ottobre 2013

Completamento dello studio (Effettivo)

1 febbraio 2014

Date di iscrizione allo studio

Primo inviato

16 agosto 2010

Primo inviato che soddisfa i criteri di controllo qualità

16 agosto 2010

Primo Inserito (Stima)

18 agosto 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 agosto 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 luglio 2015

Ultimo verificato

1 luglio 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MO22162
  • 2010-018476-24 (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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