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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

315

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
Geneesmiddel: Erlotinib [Tarceva]
Single daily oral dose
Andere namen:
  • Tarceva
Experimenteel: Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
Geneesmiddel: Erlotinib [Tarceva]
Single daily oral dose
Andere namen:
  • Tarceva

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival (PFS)
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2010

Primaire voltooiing (Werkelijk)

1 oktober 2013

Studie voltooiing (Werkelijk)

1 februari 2014

Studieregistratiedata

Eerst ingediend

16 augustus 2010

Eerst ingediend dat voldeed aan de QC-criteria

16 augustus 2010

Eerst geplaatst (Schatting)

18 augustus 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

19 augustus 2015

Laatste update ingediend die voldeed aan QC-criteria

23 juli 2015

Laatst geverifieerd

1 juli 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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