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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Fas 2
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama at Birmingham
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California
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Burbank, California, Förenta staterna, 91505
- East Valley Hematology and Oncology Medical Group, Inc.
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Duarte, California, Förenta staterna, 91010
- City of Hope
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Fountain Valley, California, Förenta staterna, 92708
- Compassionate Cancer Care Medical Group, Inc.
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Fullerton, California, Förenta staterna, 92835-3825
- St. Joseph Heritage Healthcare
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La Jolla, California, Förenta staterna, 92093-0698
- UC San Diego Moores Cancer Center
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Los Angeles, California, Förenta staterna, 90089
- University of Southern California, Norris Comprehensive Cancer Center
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Sacramento, California, Förenta staterna, 95816
- Sutter Medical Group
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San Francisco, California, Förenta staterna, 94115
- University of California San Francisco
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Santa Barbara, California, Förenta staterna, 93105
- Sansum Clinic
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Santa Maria, California, Förenta staterna, 93454
- Central Coast Medical Oncology Corporation
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Santa Monica, California, Förenta staterna, 90404
- UCLA Medical Center
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Whittier, California, Förenta staterna, 90603
- The Oncology Institute of Hope and Innovation
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20007
- Georgetown University Medical Center
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Florida
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Fleming Island, Florida, Förenta staterna, 32003
- Cancer Specialists of North Florida
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Fort Myers, Florida, Förenta staterna, 33916
- Florida Cancer Specialists and Research Institute
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Miami, Florida, Förenta staterna, 33176
- Advanced Medical Specialties
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Orlando, Florida, Förenta staterna, 32804
- Florida Hospital Cancer Institute
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Saint Petersburg, Florida, Förenta staterna, 33705
- Florida Cancer Specialists
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Weston, Florida, Förenta staterna, 33331
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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Chicago, Illinois, Förenta staterna, 60612
- University of Illinois Cancer Center
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Niles, Illinois, Förenta staterna, 60714
- Illinois Cancer Specialists
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Maryland
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Baltimore, Maryland, Förenta staterna, 21237
- Harry and Jeanette Weinberg Cancer Institute at Franklin Square
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Bethesda, Maryland, Förenta staterna, 20889
- Walter Reed Army Institute of Research
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Michigan
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Detroit, Michigan, Förenta staterna, 48201
- Barbara Ann Karmanos Cancer Institute
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68130
- Oncology Hematology West PC
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Nevada
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Henderson, Nevada, Förenta staterna, 89014
- Comprehensive Cancer Centers of Nevada
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New Jersey
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East Brunswick, New Jersey, Förenta staterna, 08816
- Regional Cancer Care Associates, LLC
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Morristown, New Jersey, Förenta staterna, 07962
- Regional Cancer Care Associates
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New York
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Bronx, New York, Förenta staterna, 10461
- Montefiore Medical Center
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Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Institute
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45267
- University of Cincinnati Medical Center
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic
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Cleveland, Ohio, Förenta staterna, 44106
- University Hospitals Case Medical Center
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University Hospital
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425
- Hollings Cancer Center
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Tennessee
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Chattanooga, Tennessee, Förenta staterna, 37404
- Tennessee Oncology, PLLC
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Nashville, Tennessee, Förenta staterna, 37203
- Tennessee Oncology, PLLC
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Nashville, Tennessee, Förenta staterna, 37212-3505
- USC/Norris Comprehensive Cancer Center
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Texas
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Austin, Texas, Förenta staterna, 78745
- Texas Oncology, PA
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Beaumont, Texas, Förenta staterna, 77702
- Texas Oncology-Beaumont
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Bedford, Texas, Förenta staterna, 76022
- Texas Oncology, P.A.
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Dallas, Texas, Förenta staterna, 75390-8852
- University of Texas Southwestern Medical Center
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Houston, Texas, Förenta staterna, 77030
- Houston Methodist Cancer Center
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Houston, Texas, Förenta staterna, 77030
- The University of Texas - MD Anderson Cancer Center
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Plano, Texas, Förenta staterna, 75075-7753
- Texas Oncology-Plano East
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Virginia
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Fairfax, Virginia, Förenta staterna, 22031
- Virginia Cancer Specialists, PC
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Washington
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Seattle, Washington, Förenta staterna, 98109
- University of Washington
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Vancouver, Washington, Förenta staterna, 98684
- Northwest Cancer Specialists, P.C.
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Yakima, Washington, Förenta staterna, 98902
- Yakima Valley Memorial Hospital, North Star Lodge
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Hong Kong, Hong Kong
- Queen Mary Hospital
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New Territories
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Hong Kong, New Territories, Hong Kong
- Prince of Wales Hospital
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Livorno, Italien, 57124
- Ospedale Civile di Livorno
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Busan, Korea, Republiken av, 602-715
- Dong-A University Hospital
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Incheon, Korea, Republiken av, 400-711
- Inha University Hospital
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Seongnam-si, Korea, Republiken av, 463-707
- Seoul National University Bundang Hospital
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Seoul, Korea, Republiken av, 135-710
- Samsung Medical Center
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Seoul, Korea, Republiken av, 138-736
- Asan Medical Center
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Seoul, Korea, Republiken av, 120-752
- Severance Hospital, Yonsei University Health System
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Suwon, Korea, Republiken av, 442-723
- The Catholic University of Korea Saint Vincent's Hospital
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Barcelona, Spanien, 08035
- Hospital Universitario Vall d'Hebron
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Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taoyuan, Taiwan, 33305
- Chang Gung Memorial Hospital Linkou
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Berlin, Tyskland
- Evangelische Lungenklinik Berlin
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Bayern
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Gauting, Bayern, Tyskland, 82131
- Asklepios Fachkliniken München-Gauting
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Niedersachsen
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Oldenburg, Niedersachsen, Tyskland, 26121
- Pius Hospital Oldenburg
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Nordrhein-Westfalen
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Köln, Nordrhein-Westfalen, Tyskland, 50937
- Universitätsklinikum Köln
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Tyskland, 55131
- Katholisches Klinikum Mainz, Sankt Hildegardis-Krankenhaus
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic or unresectable locally advanced/metastatic NSCLC
- 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
- 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
- Measureable disease according to RECIST Version 1.1
- Life expectancy of at least 3 months
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 1
- Minimum age 18 years (in certain territories, the minimum age requirement may be higher (e.g. 20 years in Japan and Taiwan)
- Adequate hematological and biological function, confirmed by defined laboratory values
- Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation
Exclusion Criteria:
- Documented evidence of an exon 20 insertion activating mutation other than A763_Y764insFQEA in the EGFR gene
- 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
- 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
- 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
- Known pre-existing interstitial lung disease
- Brain metastases
- Treatment with prohibited medications less than or equal to 14 days prior to first day of study treatment
- 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
- Prior treatment with EGFR TKIs (e.g. erlotinib, gefitinib, neratinib, afatinib, AZD9291, or dacomitinib), rociletinib or other drugs that target mutant EGFR
- Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) > 450 ms
- Inability to measure QT interval on ECG
- Personal or family history of long QT syndrome
- Implantable pacemaker or implantable cardioverter defibrillator
- Resting bradycardia < 55 beats/min
- 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.
- Females who are pregnant or breastfeeding
- 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
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
- Any other reason the investigator considers the patient should not participate in the study
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Erlotinib Mono-Therapy
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Erlotinib will be administered once a day
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Experimentell: Rociletinib Mono-Therapy
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Rociletinib will be administered twice daily
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Confirmed Response Rate
Tidsram: 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.
|
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Duration of Response
Tidsram: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months
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Duration of Response in Patients with Confirmed Response per Investigator
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Cycle 1 Day 1 to End of Treatment, up to approximately 35 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2014
Primärt slutförande (Faktisk)
28 juni 2017
Avslutad studie (Faktisk)
28 juni 2017
Studieregistreringsdatum
Först inskickad
30 juni 2014
Först inskickad som uppfyllde QC-kriterierna
7 juli 2014
Första postat (Uppskatta)
10 juli 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 maj 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 april 2019
Senast verifierad
1 april 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Proteinkinashämmare
- Erlotinib hydroklorid
Andra studie-ID-nummer
- CO-1686-022 (TIGER-1)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .