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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

100

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Erlotinib Mono-Therapy
Geneesmiddel: Erlotinib Mono-Therapy
Erlotinib will be administered once a day
Experimenteel: Rociletinib Mono-Therapy
Geneesmiddel: Rociletinib Mono-Therapy
Rociletinib will be administered twice daily

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Confirmed Response Rate
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Clovis Oncology, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2014

Primaire voltooiing (Werkelijk)

28 juni 2017

Studie voltooiing (Werkelijk)

28 juni 2017

Studieregistratiedata

Eerst ingediend

30 juni 2014

Eerst ingediend dat voldeed aan de QC-criteria

7 juli 2014

Eerst geplaatst (Schatting)

10 juli 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 mei 2019

Laatste update ingediend die voldeed aan QC-criteria

29 april 2019

Laatst geverifieerd

1 april 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CO-1686-022 (TIGER-1)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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