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Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients (ICOGEN)

21. januar 2014 opdateret af: Betta Pharmaceuticals Co., Ltd.

A Randomized,Double-blind,Multicenter Phase III Trial to Evaluate the Safety and Efficacy of Icotinib and Gefitinib in Advanced NSCLC Patients Previously Treated With Chemotherapy

The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years . It is the leading cause of death of cancer in man and 2nd in women. With the development of gefitinib and erlotinib, EGFR-TKI (epidermal growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for the treatment of these patients in recent years, especially for NSCLC patients in Asia including China. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. It appears to be at least as good as gefitinib in terms of efficacy and better in terms of safety in phase I/II trials. In this study, a randomized, double-blind, gefitinib as control, multi-center phase III trial was designed to evaluate the safety and efficacy of icotinib in the treatment of advanced NSCLC patients after failure of 1 or 2 chemotherapy. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point. A total of 400 patients will be recruited. EGFR and K-ras gene mutational analysis as well as a population PK study have also been proposed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

399

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100853
        • Chinese PLA General Hospital
      • Beijing, Beijing, Kina, 100020
        • Beijing Chao-Yang Hospital
      • Beijing, Beijing, Kina, 100032
        • Peking Union Medical College Hospital
      • Beijing, Beijing, Kina, 100071
        • 307 Hospital of PLA
      • Beijing, Beijing, Kina, 101149
        • Beijing Chest Hospital
      • Beijing, Beijing, Kina, 100021
        • Cancer Hospital, Chinese Academy of Medical Science
      • Beijing, Beijing, Kina, 100036
        • Bejing Cancer Hospital
      • Beijing, Beijing, Kina, 100079
        • Peking University Third Hospital
    • Chongqing
      • Chongqing, Chongqing, Kina, 400042
        • Third Affiliated Hospital, Third Military Medical University
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Nanfang Hospital, Southern Medical University
      • Guangzhou, Guangdong, Kina, 510080
        • Guangdong General Hospital
      • Guangzhou, Guangdong, Kina, 510000
        • Guanghzou General Hospital of PLA
      • Guanzhou, Guangdong, Kina, 510060
        • Sun Yat-Sen Univerisity Cancer Center
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, Kina, 410011
        • The second Xiangya Hospital,Central South University
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210009
        • Jiangsu Cancer Hospital
      • Nanjing, Jiangsu, Kina, 210002
        • 81 Hospital of PLA
      • Nanjing, Jiangsu, Kina, 210002
        • Nanjing General Hospital of Nanjing Command，PLA
    • Jilin
      • Changchun, Jilin, Kina, 130012
        • Jilin Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, Kina, 200433
        • Shanghai Pulmonary Hospital
      • Shanghai, Shanghai, Kina, 200032
        • Zhongshan Hospital,Fudan University
      • Shanghai, Shanghai, Kina, 200433
        • Changhai Hospital, Second Military Medical University
      • Shanghai, Shanghai, Kina, 200023
        • Ruijin Hospital，Shanghai Jiao-Tong University
    • Shanxi
      • Xi-An, Shanxi, Kina, 710032
        • Xijing Hospital, Fourth Military Medical University
      • Xi-an, Shanxi, Kina, 710000
        • Tangdu Hospital, Fourth Military Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, Kina, 310022
        • The First Affiliated Hospital of College of Medicine, Zhejiang University

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
  2. Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment; =.

Exclusion Criteria:

1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Icotinib
125 mg tre gange dagligt (375 mg pr. dag) gennem munden
Medicin: Icotinib
125 mg tre gange dagligt (375 mg pr. dag) gennem munden
Andre navne:
  • BPI-2009
  • Conmana
Aktiv komparator: Gefitinib
250 mg every 24 hours by mouth
Medicin: Gefitinib
250 mg every 24 hours by mouth
Andre navne:
  • Iressa
  • ZD1839

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival
Tidsramme: 2-7 months
Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
2-7 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: From first study treatment until time of death
Median number of months from first study treatment until time of death
From first study treatment until time of death
Best Tumor Response
Tidsramme: While receiving study treatment; assessed every 21 days until progression
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline
While receiving study treatment; assessed every 21 days until progression
Time To Progression
Tidsramme: 2-7 months
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.
2-7 months
Safety and Tolerability
Tidsramme: Assessed over two years

Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.

Grade 3 = Severe Grade 4 = Life-threatening or disabling
Assessed over two years

Samarbejdspartnere og efterforskere

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

Sponsor

Betta Pharmaceuticals Co., Ltd.

Efterforskere

  • Ledende efterforsker: Li Zhang, M.D., Sun Yat-sen University
  • Ledende efterforsker: Yan Sun, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Studieleder: Fenlai Tan, M.D./Ph.D., Zhejiang Betapharma Inc.

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. februar 2009

Primær færdiggørelse (Faktiske)

1. marts 2010

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

27. december 2009

Først indsendt, der opfyldte QC-kriterier

29. december 2009

Først opslået (Skøn)

30. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BPI-2009

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 .

Kliniske forsøg med Ikke-småcellet lungekræft

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