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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 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

124

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
    • Victoria
      • East Bentleigh, Victoria, Australien, VIC 3165
      • Geelong, Victoria, Australien, 3220
  • Belgien
      • Leuven, Belgien, 3000
  • Frankreich
      • Bayonne, Frankreich, 64100
      • Dijon, Frankreich, 21079
      • Le Mans, Frankreich, 72037
      • Marseille, Frankreich, 13273
      • Paris, Frankreich, 75674
      • Strasbourg, Frankreich, 67091
      • Vandoeuvre-les-nancy, Frankreich, 54511
  • 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, Republik von
      • Bundang City, Korea, Republik von, 463-802
      • Daegu, Korea, Republik von, 700-712
      • Gyeonggi-do, Korea, Republik von, 411-769
      • Incheon, Korea, Republik von, 405-760
      • Seoul, Korea, Republik von, 138-736
      • Seoul, Korea, Republik von, 110-744
      • Seoul, Korea, Republik von, 120-752
      • Seoul, Korea, Republik von, 135-710
      • Seoul, Korea, Republik von, 137-807
      • Suwon, Korea, Republik von
  • Litauen
      • Kaunas, Litauen, 50009
      • Vilnius, Litauen, 08660
  • Niederlande
      • 's Hertogenbosch, Niederlande, 5211 RW
      • Amsterdam, Niederlande, 1007 MB
      • Eindhoven, Niederlande, 5623 EJ
      • Groningen, Niederlande, 9713 GZ
      • Heerlen, Niederlande, 6419 PC
      • Maastricht, Niederlande, 6229 HX
      • Rotterdam, Niederlande, 3045 PM
  • Polen
      • Lodz, Polen, 91-520
      • Lublin, Polen, 20-950
      • Otwock, Polen, 05-400
  • Rumänien
      • Bucuresti, Rumänien, 022328
      • Cluj Napoca, Rumänien, 400015
      • Timisoara, Rumänien, 1900
  • Singapur
      • Singapore, Singapur, 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
  • Vereinigtes Königreich
      • Dudley, Vereinigtes Königreich, DY1 2HQ
      • Guildford, Vereinigtes Königreich, GU2 7XX
      • Manchester, Vereinigtes Königreich, M2O 4BX

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Arzneimittel: Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Andere Namen:
  • Avastin
Arzneimittel: Standard platinum-based chemotherapy
At the discretion of the investigator
Experimental: 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.
Arzneimittel: Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Andere Namen:
  • Avastin
Arzneimittel: Erlotinib
150 mg, PO, daily
Andere Namen:
  • Tarceva

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Disease Progression or Death
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Who Died
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2008

Primärer Abschluss (Tatsächlich)

1. Januar 2010

Studienabschluss (Tatsächlich)

1. Januar 2010

Studienanmeldedaten

Zuerst eingereicht

18. September 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. September 2007

Zuerst gepostet (Schätzen)

19. September 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

11. November 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. November 2014

Zuletzt verifiziert

1. November 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BO20571

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