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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 avril 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Réel)

100

Phase

  • Phase 2
  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Erlotinib Mono-Therapy
Médicament: Erlotinib Mono-Therapy
Erlotinib will be administered once a day
Expérimental: Rociletinib Mono-Therapy
Médicament: Rociletinib Mono-Therapy
Rociletinib will be administered twice daily

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Confirmed Response Rate
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Clovis Oncology, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2014

Achèvement primaire (Réel)

28 juin 2017

Achèvement de l'étude (Réel)

28 juin 2017

Dates d'inscription aux études

Première soumission

30 juin 2014

Première soumission répondant aux critères de contrôle qualité

7 juillet 2014

Première publication (Estimation)

10 juillet 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 mai 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 avril 2019

Dernière vérification

1 avril 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CO-1686-022 (TIGER-1)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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