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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 aprile 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

100

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Erlotinib Mono-Therapy
Droga: Erlotinib Mono-Therapy
Erlotinib will be administered once a day
Sperimentale: Rociletinib Mono-Therapy
Droga: Rociletinib Mono-Therapy
Rociletinib will be administered twice daily

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Confirmed Response Rate
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Clovis Oncology, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2014

Completamento primario (Effettivo)

28 giugno 2017

Completamento dello studio (Effettivo)

28 giugno 2017

Date di iscrizione allo studio

Primo inviato

30 giugno 2014

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2014

Primo Inserito (Stima)

10 luglio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CO-1686-022 (TIGER-1)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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