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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

315

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Danmark
      • Hillerod, Danmark, 3400
      • København, Danmark, 2100
      • Naestved, Danmark, 4700
      • Roskilde, Danmark, 4000
  • Egypten
      • Cairo, Egypten, 11796
      • Cairo, Egypten
  • Frankrike
      • Caen, Frankrike, 14076
      • Limoges, Frankrike, 87042
      • Marseille, Frankrike, 13915
      • Paris, Frankrike, 75014
      • Paris, Frankrike, 75908
      • Paris, Frankrike, 75674
      • Pontoise, Frankrike, 95300
  • Kalkon
      • Ankara, Kalkon, 06200
      • Ankara, Kalkon, 06000
      • Eskisehir, Kalkon, 26480
      • Gaziantep, Kalkon, 27310
      • Izmir, Kalkon, 35340
      • Izmir, Kalkon, 35110
      • Konya, Kalkon, 42050
  • 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
  • Nederländerna
      • Amsterdam, Nederländerna, 1007 MB
      • Breda, Nederländerna, 4818 CK
      • Nieuwegein, Nederländerna, 3435 CM
      • Zwolle, Nederländerna, 8011 JW
  • Schweiz
      • Baden, Schweiz, 5404
      • Basel, Schweiz, 4031
      • Bern, Schweiz, 3011
      • Fribourg, Schweiz, 1708
  • Spanien
      • Barcelona, Spanien, 08035
      • Barcelona, Spanien, 08041
      • Madrid, Spanien, 28040
      • Madrid, Spanien, 28041
      • Malaga, Spanien, 29010
      • Sevilla, Spanien, 41013
      • Valencia, Spanien, 46009
    • Barcelona
      • Sabadell, Barcelona, Barcelona, Spanien, 08208
  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
Läkemedel: Erlotinib [Tarceva]
Single daily oral dose
Andra namn:
  • Tarceva
Experimentell: Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
Läkemedel: Erlotinib [Tarceva]
Single daily oral dose
Andra namn:
  • Tarceva

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-Free Survival (PFS)
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival (OS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2010

Primärt slutförande (Faktisk)

1 oktober 2013

Avslutad studie (Faktisk)

1 februari 2014

Studieregistreringsdatum

Först inskickad

16 augusti 2010

Först inskickad som uppfyllde QC-kriterierna

16 augusti 2010

Första postat (Uppskatta)

18 augusti 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

19 augusti 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juli 2015

Senast verifierad

1 juli 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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