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TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy (EGFR)

29. april 2019 opdateret af: Clovis Oncology, Inc.

TIGER 1: A Randomized, Open-Label, Phase 2/3 Study of CO-1686 or Erlotinib as First-Line Treatment of Patients With EGFR-Mutant Advanced/Metastatic NSCLC

The purpose of this study is to compare the safety and anti-tumor effect of rociletinib with erlotinib in patients whose tumors have specific EGFR mutations and who have not previously received any treatment for advanced/metastatic EGFR mutated NSCLC. This study is a 'Randomized' Study. This means that upon entering the study, patients will be randomly assigned to be dosed with either rociletinib twice a day or erlotinib once a day. Patients will continue to take either rociletinib or erlotinib until it is no longer beneficial.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized, Phase 2/3 study of rociletinib versus erlotinib as a first-line treatment for patients with EGFR-mutant advanced/metastatic NSCLC whose tumors have EGFR-activating mutations. The study will consist of Phase 2 and Phase 3 parts which will use the same enrollment criteria and treatment assignment principles. Patients will be randomized 1:1 to erlotinib or rociletinib. The Phase 2 part is an open-label study. In the Phase 3 part, the sponsor will be blinded to the efficacy and safety results. The study will consist of a screening phase to establish study eligibility (including tumor genotype) and document baseline measurements, a treatment phase, in which patients will receive either rociletinib BID (twice a day) or erlotinib QD (once daily) to ascertain safety and efficacy until protocol-defined disease progression, and a follow-up phase, to monitor survival status and subsequent NSCLC cancer therapy. In the Phase 2 part only, patients initially randomized to erlotinib may be eligible to participate in an optional crossover phase to receive rociletinib if they demonstrate the T790M resistance mutation after radiographic progression on erlotinib treatment among other eligibility requirements. Patients eligible for this study must have EGFR-mutated NSCLC who have not been treated with an EGFR-directed therapy.Treatment with rociletinib or erlotinib is continuous. Each 28 day period of treatment will represent one cycle, with dosing initiated on Cycle 1 Day 1 (C1 D1).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • California
      • Burbank, California, Forenede Stater, 91505
        • East Valley Hematology and Oncology Medical Group, Inc.
      • Duarte, California, Forenede Stater, 91010
        • City of Hope
      • Fountain Valley, California, Forenede Stater, 92708
        • Compassionate Cancer Care Medical Group, Inc.
      • Fullerton, California, Forenede Stater, 92835-3825
        • St. Joseph Heritage Healthcare
      • La Jolla, California, Forenede Stater, 92093-0698
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, Forenede Stater, 90089
        • University of Southern California, Norris Comprehensive Cancer Center
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Medical Group
      • San Francisco, California, Forenede Stater, 94115
        • University of California San Francisco
      • Santa Barbara, California, Forenede Stater, 93105
        • Sansum Clinic
      • Santa Maria, California, Forenede Stater, 93454
        • Central Coast Medical Oncology Corporation
      • Santa Monica, California, Forenede Stater, 90404
        • UCLA Medical Center
      • Whittier, California, Forenede Stater, 90603
        • The Oncology Institute of Hope and Innovation
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Georgetown University Medical Center
    • Florida
      • Fleming Island, Florida, Forenede Stater, 32003
        • Cancer Specialists of North Florida
      • Fort Myers, Florida, Forenede Stater, 33916
        • Florida Cancer Specialists and Research Institute
      • Miami, Florida, Forenede Stater, 33176
        • Advanced Medical Specialties
      • Orlando, Florida, Forenede Stater, 32804
        • Florida Hospital Cancer Institute
      • Saint Petersburg, Florida, Forenede Stater, 33705
        • Florida Cancer Specialists
      • Weston, Florida, Forenede Stater, 33331
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois Cancer Center
      • Niles, Illinois, Forenede Stater, 60714
        • Illinois Cancer Specialists
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21237
        • Harry and Jeanette Weinberg Cancer Institute at Franklin Square
      • Bethesda, Maryland, Forenede Stater, 20889
        • Walter Reed Army Institute of Research
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68130
        • Oncology Hematology West PC
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89014
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • East Brunswick, New Jersey, Forenede Stater, 08816
        • Regional Cancer Care Associates, LLC
      • Morristown, New Jersey, Forenede Stater, 07962
        • Regional Cancer Care Associates
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Case Medical Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Hollings Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Forenede Stater, 37203
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Forenede Stater, 37212-3505
        • USC/Norris Comprehensive Cancer Center
    • Texas
      • Austin, Texas, Forenede Stater, 78745
        • Texas Oncology, PA
      • Beaumont, Texas, Forenede Stater, 77702
        • Texas Oncology-Beaumont
      • Bedford, Texas, Forenede Stater, 76022
        • Texas Oncology, P.A.
      • Dallas, Texas, Forenede Stater, 75390-8852
        • University of Texas Southwestern Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • The University of Texas - MD Anderson Cancer Center
      • Plano, Texas, Forenede Stater, 75075-7753
        • Texas Oncology-Plano East
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Virginia Cancer Specialists, PC
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • University of Washington
      • Vancouver, Washington, Forenede Stater, 98684
        • Northwest Cancer Specialists, P.C.
      • Yakima, Washington, Forenede Stater, 98902
        • Yakima Valley Memorial Hospital, North Star Lodge
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
    • New Territories
      • Hong Kong, New Territories, Hong Kong
        • Prince of Wales Hospital
  • Italien
      • Livorno, Italien, 57124
        • Ospedale Civile di Livorno
  • Korea, Republikken
      • Busan, Korea, Republikken, 602-715
        • Dong-A University Hospital
      • Incheon, Korea, Republikken, 400-711
        • Inha University Hospital
      • Seongnam-si, Korea, Republikken, 463-707
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republikken, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republikken, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republikken, 120-752
        • Severance Hospital, Yonsei University Health System
      • Suwon, Korea, Republikken, 442-723
        • The Catholic University of Korea Saint Vincent's Hospital
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spanien, 28034
        • Hospital Universitario Ramon y Cajal
  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 33305
        • Chang Gung Memorial Hospital LinKou
  • Tyskland
      • Berlin, Tyskland
        • Evangelische Lungenklinik Berlin
    • Bayern
      • Gauting, Bayern, Tyskland, 82131
        • Asklepios Fachkliniken München-Gauting
    • Niedersachsen
      • Oldenburg, Niedersachsen, Tyskland, 26121
        • Pius Hospital Oldenburg
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Tyskland, 50937
        • Universitatsklinikum Koln
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Tyskland, 55131
        • Katholisches Klinikum Mainz, Sankt Hildegardis-Krankenhaus

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:

  1. Histologically or cytologically confirmed metastatic or unresectable locally advanced/metastatic NSCLC
  2. Documented evidence of a tumor with activating EGFR mutations by local testing. Patients with exon 20 insertions are not eligible with the exception of patients with documented evidence of the exon 20 insertion A763_Y764insFQEA in the EGFR gene
  3. Have undergone a biopsy or surgical resection of either primary or metastatic tumor tissue within 60 days of the first day of study treatment, C1D1, and have tissue available to send to sponsor laboratories or are able to undergo a biopsy during screening and provide tissue to sponsor laboratories
  4. Measureable disease according to RECIST Version 1.1
  5. Life expectancy of at least 3 months
  6. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 1
  7. Minimum age 18 years (in certain territories, the minimum age requirement may be higher (e.g. 20 years in Japan and Taiwan)
  8. Adequate hematological and biological function, confirmed by defined laboratory values
  9. Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation

Exclusion Criteria:

  1. Documented evidence of an exon 20 insertion activating mutation other than A763_Y764insFQEA in the EGFR gene
  2. Prior treatment with cytotoxic chemotherapy for advanced NSCLC; neoadjuvant/adjuvant chemotherapy is permitted if at least 6 months has elapsed between the end of chemotherapy and randomization
  3. Active second malignancy; i.e., patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment
  4. Patients with a history of malignancy that has been completely treated, and currently with no evidence of that cancer, are permitted to enroll in the trial provided all chemotherapy was completed > 6 months prior and/or bone marrow transplant > 2 years prior to first day of study treatment
  5. Known pre-existing interstitial lung disease
  6. Brain metastases
  7. Treatment with prohibited medications less than or equal to 14 days prior to first day of study treatment
  8. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval if that treatment cannot be either discontinued or switched to a different medication prior to administration of study drug
  9. Prior treatment with EGFR TKIs (e.g. erlotinib, gefitinib, neratinib, afatinib, AZD9291, or dacomitinib), rociletinib or other drugs that target mutant EGFR
  10. Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) > 450 ms
  11. Inability to measure QT interval on ECG
  12. Personal or family history of long QT syndrome
  13. Implantable pacemaker or implantable cardioverter defibrillator
  14. Resting bradycardia < 55 beats/min
  15. Non-study related surgical procedures less than or equal to 7 days prior to administration of study drug. In all cases, the patient must be sufficiently recovered and stable before treatment administration.
  16. Females who are pregnant or breastfeeding
  17. Refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib and 2 weeks after the last dose of erlotinib
  18. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
  19. Any other reason the investigator considers the patient should not participate in the study

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: Erlotinib Mono-Therapy
Medicin: Erlotinib Mono-Therapy
Erlotinib will be administered once a day
Eksperimentel: Rociletinib Mono-Therapy
Medicin: Rociletinib Mono-Therapy
Rociletinib will be administered twice daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
Tidsramme: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months
To compare the antitumor efficacy of oral single-agent rociletinib with that of erlotinib as measured by progression-free survival (PFS), when administered as a first-line targeted treatment to patients with EGFR-mutated, advanced NSCLC.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.
Cycle 1 Day 1 to End of Treatment, up to approximately 35 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Confirmed Response Rate
Tidsramme: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months.

Proportion of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as:

Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

Overall Response (OR),is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment was dependent on the achievement of both measurement and confirmation criteria.
Cycle 1 Day 1 to End of Treatment, up to approximately 35 months.
Duration of Response
Tidsramme: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months
Duration of Response in Patients with Confirmed Response per Investigator
Cycle 1 Day 1 to End of Treatment, up to approximately 35 months

Samarbejdspartnere og efterforskere

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

Sponsor

Clovis Oncology, Inc.

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. november 2014

Primær færdiggørelse (Faktiske)

28. juni 2017

Studieafslutning (Faktiske)

28. juni 2017

Datoer for studieregistrering

Først indsendt

30. juni 2014

Først indsendt, der opfyldte QC-kriterier

7. juli 2014

Først opslået (Skøn)

10. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CO-1686-022 (TIGER-1)

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

Kliniske forsøg med Erlotinib Mono-Therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Azerbaijan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner