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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 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama at Birmingham
    • California
      • Burbank, California, Forente stater, 91505
        • East Valley Hematology and Oncology Medical Group, Inc.
      • Duarte, California, Forente stater, 91010
        • City of Hope
      • Fountain Valley, California, Forente stater, 92708
        • Compassionate Cancer Care Medical Group, Inc.
      • Fullerton, California, Forente stater, 92835-3825
        • St. Joseph Heritage Healthcare
      • La Jolla, California, Forente stater, 92093-0698
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, Forente stater, 90089
        • University of Southern California, Norris Comprehensive Cancer Center
      • Sacramento, California, Forente stater, 95816
        • Sutter Medical Group
      • San Francisco, California, Forente stater, 94115
        • University of California San Francisco
      • Santa Barbara, California, Forente stater, 93105
        • Sansum Clinic
      • Santa Maria, California, Forente stater, 93454
        • Central Coast Medical Oncology Corporation
      • Santa Monica, California, Forente stater, 90404
        • UCLA Medical Center
      • Whittier, California, Forente stater, 90603
        • The Oncology Institute of Hope and Innovation
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20007
        • Georgetown University Medical Center
    • Florida
      • Fleming Island, Florida, Forente stater, 32003
        • Cancer Specialists of North Florida
      • Fort Myers, Florida, Forente stater, 33916
        • Florida Cancer Specialists and Research Institute
      • Miami, Florida, Forente stater, 33176
        • Advanced Medical Specialties
      • Orlando, Florida, Forente stater, 32804
        • Florida Hospital Cancer Institute
      • Saint Petersburg, Florida, Forente stater, 33705
        • Florida Cancer Specialists
      • Weston, Florida, Forente stater, 33331
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern University
      • Chicago, Illinois, Forente stater, 60612
        • University of Illinois Cancer Center
      • Niles, Illinois, Forente stater, 60714
        • Illinois Cancer Specialists
    • Maryland
      • Baltimore, Maryland, Forente stater, 21237
        • Harry and Jeanette Weinberg Cancer Institute at Franklin Square
      • Bethesda, Maryland, Forente stater, 20889
        • Walter Reed Army Institute of Research
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68130
        • Oncology Hematology West PC
    • Nevada
      • Henderson, Nevada, Forente stater, 89014
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • East Brunswick, New Jersey, Forente stater, 08816
        • Regional Cancer Care Associates, LLC
      • Morristown, New Jersey, Forente stater, 07962
        • Regional Cancer Care Associates
    • New York
      • Bronx, New York, Forente stater, 10461
        • Montefiore Medical Center
      • Buffalo, New York, Forente stater, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Forente stater, 44106
        • University Hospitals Case Medical Center
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Hollings Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37404
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Forente stater, 37203
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, Forente stater, 37212-3505
        • USC/Norris Comprehensive Cancer Center
    • Texas
      • Austin, Texas, Forente stater, 78745
        • Texas Oncology, PA
      • Beaumont, Texas, Forente stater, 77702
        • Texas Oncology-Beaumont
      • Bedford, Texas, Forente stater, 76022
        • Texas Oncology, P.A.
      • Dallas, Texas, Forente stater, 75390-8852
        • University of Texas Southwestern Medical Center
      • Houston, Texas, Forente stater, 77030
        • Houston Methodist Cancer Center
      • Houston, Texas, Forente stater, 77030
        • The University of Texas - MD Anderson Cancer Center
      • Plano, Texas, Forente stater, 75075-7753
        • Texas Oncology-Plano East
    • Virginia
      • Fairfax, Virginia, Forente stater, 22031
        • Virginia Cancer Specialists, PC
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • University of Washington
      • Vancouver, Washington, Forente stater, 98684
        • Northwest Cancer Specialists, P.C.
      • Yakima, Washington, Forente 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
  • Italia
      • Livorno, Italia, 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
  • Spania
      • Barcelona, Spania, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spania, 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
        • Universitätsklinikum Köln
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Tyskland, 55131
        • Katholisches Klinikum Mainz, Sankt Hildegardis-Krankenhaus

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Erlotinib Mono-Therapy
Legemiddel: Erlotinib Mono-Therapy
Erlotinib will be administered once a day
Eksperimentell: Rociletinib Mono-Therapy
Legemiddel: Rociletinib Mono-Therapy
Rociletinib will be administered twice daily

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Clovis Oncology, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2014

Primær fullføring (Faktiske)

28. juni 2017

Studiet fullført (Faktiske)

28. juni 2017

Datoer for studieregistrering

Først innsendt

30. juni 2014

Først innsendt som oppfylte QC-kriteriene

7. juli 2014

Først lagt ut (Anslag)

10. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CO-1686-022 (TIGER-1)

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