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A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.

4. november 2014 opdateret af: Hoffmann-La Roche

A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer

This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

124

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • Victoria
      • East Bentleigh, Victoria, Australien, VIC 3165
      • Geelong, Victoria, Australien, 3220
  • Belgien
      • Leuven, Belgien, 3000
  • Det Forenede Kongerige
      • Dudley, Det Forenede Kongerige, DY1 2HQ
      • Guildford, Det Forenede Kongerige, GU2 7XX
      • Manchester, Det Forenede Kongerige, M2O 4BX
  • Frankrig
      • Bayonne, Frankrig, 64100
      • Dijon, Frankrig, 21079
      • Le Mans, Frankrig, 72037
      • Marseille, Frankrig, 13273
      • Paris, Frankrig, 75674
      • Strasbourg, Frankrig, 67091
      • Vandoeuvre-les-nancy, Frankrig, 54511
  • Holland
      • 's Hertogenbosch, Holland, 5211 RW
      • Amsterdam, Holland, 1007 MB
      • Eindhoven, Holland, 5623 EJ
      • Groningen, Holland, 9713 GZ
      • Heerlen, Holland, 6419 PC
      • Maastricht, Holland, 6229 HX
      • Rotterdam, Holland, 3045 PM
  • Italien
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italien, 33081
    • Lombardia
      • Milano, Lombardia, Italien, 20133
    • Marche
      • Ancona, Marche, Italien, 60121
    • Toscana
      • Lido Di Camaiore, Toscana, Italien, 55043
  • Korea, Republikken
      • Bundang City, Korea, Republikken, 463-802
      • Daegu, Korea, Republikken, 700-712
      • Gyeonggi-do, Korea, Republikken, 411-769
      • Incheon, Korea, Republikken, 405-760
      • Seoul, Korea, Republikken, 138-736
      • Seoul, Korea, Republikken, 110-744
      • Seoul, Korea, Republikken, 120-752
      • Seoul, Korea, Republikken, 135-710
      • Seoul, Korea, Republikken, 137-807
      • Suwon, Korea, Republikken
  • Litauen
      • Kaunas, Litauen, 50009
      • Vilnius, Litauen, 08660
  • Polen
      • Lodz, Polen, 91-520
      • Lublin, Polen, 20-950
      • Otwock, Polen, 05-400
  • Rumænien
      • Bucuresti, Rumænien, 022328
      • Cluj Napoca, Rumænien, 400015
      • Timisoara, Rumænien, 1900
  • Singapore
      • Singapore, Singapore, 119074
  • Spanien
      • Alicante, Spanien, 3010
      • Barcelona, Spanien, 08035
      • La Coruña, Spanien, 15006
      • Madrid, Spanien, 28046
      • Madrid, Spanien, 28041
      • Madrid, Spanien, 28222
      • Malaga, Spanien, 29010
      • Sevilla, Spanien, 41014
  • Taiwan
      • Changhua, Taiwan, 500
      • Kaohsiung, Taiwan, 00833
      • Tainan, Taiwan, 710
      • Taipei, Taiwan
      • Taipei, Taiwan, 114
      • Taipei, Taiwan, 112

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • advanced (stage IIIb and IV) non-small cell lung cancer;
  • measurable disease;
  • ECOG PS 0-1.

Exclusion Criteria:

  • prior chemotherapy or treatment with another systemic anti-cancer agent;
  • radiotherapy within 4 weeks prior to first dose of study treatment;
  • CNS metastases;
  • other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Bevacizumab, Chemotherapy
Participants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcitabine, 1250 mg/ square meter (m^2), IV, on Days 1 and 8 of Cycles 1 through 4 or 6, and cisplatin 80 mg/m^2, IV, on Day 1 of Cycles 1 through 4 or 6; or paclitaxel, 200 mg/m^2, IV, and carboplatin area under the curve (AUC) 6 mg/ milliliter (ml) multiplied by (*) minute (min) on Day 1 of Cycles 1 through 4 or 6. The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
Medicin: Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Andre navne:
  • Avastin
Medicin: Standard platinum-based chemotherapy
At the discretion of the investigator
Eksperimentel: Bevacizumab, Erlotinib
Participants received bevacizumab, 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib, 150 mg, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
Medicin: Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Andre navne:
  • Avastin
Medicin: Erlotinib
150 mg, PO, daily
Andre navne:
  • Tarceva

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Disease Progression or Death
Tidsramme: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
PFS
Tidsramme: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Died
Tidsramme: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause. Participants were censored at final analysis at the date the participant was last known to be alive.
Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
OS
Tidsramme: Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
The median time, in months, from randomization to OS event. Participants were censored at final analysis at the date the participant was last known to be alive.
Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
Tidsramme: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started. Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
Percentage of Participants With Disease Control According to RECIST V 1.0
Tidsramme: Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit
Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry. Participants without a post-BL assessment of response were considered as having no disease control. The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.
Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2008

Primær færdiggørelse (Faktiske)

1. januar 2010

Studieafslutning (Faktiske)

1. januar 2010

Datoer for studieregistrering

Først indsendt

18. september 2007

Først indsendt, der opfyldte QC-kriterier

18. september 2007

Først opslået (Skøn)

19. september 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BO20571

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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