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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 juillet 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

315

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
Médicament: Erlotinib [Tarceva]
Single daily oral dose
Autres noms:
  • Tarceva
Expérimental: Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
Médicament: Erlotinib [Tarceva]
Single daily oral dose
Autres noms:
  • Tarceva

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression-Free Survival (PFS)
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2010

Achèvement primaire (Réel)

1 octobre 2013

Achèvement de l'étude (Réel)

1 février 2014

Dates d'inscription aux études

Première soumission

16 août 2010

Première soumission répondant aux critères de contrôle qualité

16 août 2010

Première publication (Estimation)

18 août 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

19 août 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 juillet 2015

Dernière vérification

1 juillet 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MO22162
  • 2010-018476-24 (Numéro EudraCT)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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