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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. juli 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

315

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
Legemiddel: Erlotinib [Tarceva]
Single daily oral dose
Andre navn:
  • Tarceva
Eksperimentell: Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
Legemiddel: Erlotinib [Tarceva]
Single daily oral dose
Andre navn:
  • Tarceva

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2010

Primær fullføring (Faktiske)

1. oktober 2013

Studiet fullført (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først innsendt

16. august 2010

Først innsendt som oppfylte QC-kriteriene

16. august 2010

Først lagt ut (Anslag)

18. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. august 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juli 2015

Sist bekreftet

1. juli 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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