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)
2019년 4월 29일 업데이트: 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.
연구 개요
상세 설명
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).
연구 유형
중재적
등록 (실제)
100
단계
- 2 단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Taichung, 대만, 40705
- Taichung Veterans General Hospital
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Taipei, 대만, 11217
- Taipei Veterans General Hospital
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Taoyuan, 대만, 33305
- Chang Gung Memorial Hospital LinKou
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Busan, 대한민국, 602-715
- Dong-A University Hospital
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Incheon, 대한민국, 400-711
- Inha University Hospital
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Seongnam-si, 대한민국, 463-707
- Seoul National University Bundang Hospital
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Seoul, 대한민국, 135-710
- Samsung Medical Center
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Seoul, 대한민국, 138-736
- Asan Medical Center
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Seoul, 대한민국, 120-752
- Severance Hospital, Yonsei University Health System
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Suwon, 대한민국, 442-723
- The Catholic University of Korea Saint Vincent's Hospital
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Berlin, 독일
- Evangelische Lungenklinik Berlin
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Bayern
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Gauting, Bayern, 독일, 82131
- Asklepios Fachkliniken München-Gauting
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Niedersachsen
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Oldenburg, Niedersachsen, 독일, 26121
- Pius Hospital Oldenburg
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Nordrhein-Westfalen
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Köln, Nordrhein-Westfalen, 독일, 50937
- Universitatsklinikum Koln
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, 독일, 55131
- Katholisches Klinikum Mainz, Sankt Hildegardis-Krankenhaus
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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California
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Burbank, California, 미국, 91505
- East Valley Hematology and Oncology Medical Group, Inc.
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Duarte, California, 미국, 91010
- City of Hope
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Fountain Valley, California, 미국, 92708
- Compassionate Cancer Care Medical Group, Inc.
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Fullerton, California, 미국, 92835-3825
- St. Joseph Heritage Healthcare
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La Jolla, California, 미국, 92093-0698
- UC San Diego Moores Cancer Center
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Los Angeles, California, 미국, 90089
- University of Southern California, Norris Comprehensive Cancer Center
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Sacramento, California, 미국, 95816
- Sutter Medical Group
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San Francisco, California, 미국, 94115
- University of California San Francisco
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Santa Barbara, California, 미국, 93105
- Sansum Clinic
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Santa Maria, California, 미국, 93454
- Central Coast Medical Oncology Corporation
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Santa Monica, California, 미국, 90404
- UCLA Medical Center
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Whittier, California, 미국, 90603
- The Oncology Institute of Hope and Innovation
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, 미국, 20007
- Georgetown University Medical Center
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Florida
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Fleming Island, Florida, 미국, 32003
- Cancer Specialists of North Florida
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Fort Myers, Florida, 미국, 33916
- Florida Cancer Specialists and Research Institute
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Miami, Florida, 미국, 33176
- Advanced Medical Specialties
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Orlando, Florida, 미국, 32804
- Florida Hospital Cancer Institute
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Saint Petersburg, Florida, 미국, 33705
- Florida Cancer Specialists
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Weston, Florida, 미국, 33331
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Chicago, Illinois, 미국, 60612
- University of Illinois Cancer Center
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Niles, Illinois, 미국, 60714
- Illinois Cancer Specialists
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Maryland
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Baltimore, Maryland, 미국, 21237
- Harry and Jeanette Weinberg Cancer Institute at Franklin Square
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Bethesda, Maryland, 미국, 20889
- Walter Reed Army Institute of Research
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Michigan
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Detroit, Michigan, 미국, 48201
- Barbara Ann Karmanos Cancer Institute
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Nebraska
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Omaha, Nebraska, 미국, 68130
- Oncology Hematology West PC
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Nevada
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Henderson, Nevada, 미국, 89014
- Comprehensive Cancer Centers of Nevada
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New Jersey
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East Brunswick, New Jersey, 미국, 08816
- Regional Cancer Care Associates, LLC
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Morristown, New Jersey, 미국, 07962
- Regional Cancer Care Associates
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New York
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Bronx, New York, 미국, 10461
- Montefiore Medical Center
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Buffalo, New York, 미국, 14263
- Roswell Park Cancer Institute
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, 미국, 45267
- University of Cincinnati Medical Center
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic
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Cleveland, Ohio, 미국, 44106
- University Hospitals Case Medical Center
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Thomas Jefferson University Hospital
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Hollings Cancer Center
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Tennessee
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Chattanooga, Tennessee, 미국, 37404
- Tennessee Oncology, PLLC
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Nashville, Tennessee, 미국, 37203
- Tennessee Oncology, PLLC
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Nashville, Tennessee, 미국, 37212-3505
- USC/Norris Comprehensive Cancer Center
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Texas
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Austin, Texas, 미국, 78745
- Texas Oncology, PA
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Beaumont, Texas, 미국, 77702
- Texas Oncology-Beaumont
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Bedford, Texas, 미국, 76022
- Texas Oncology, P.A.
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Dallas, Texas, 미국, 75390-8852
- University of Texas Southwestern Medical Center
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Houston, Texas, 미국, 77030
- Houston Methodist Cancer Center
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Houston, Texas, 미국, 77030
- The University of Texas - MD Anderson Cancer Center
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Plano, Texas, 미국, 75075-7753
- Texas Oncology-Plano East
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Virginia
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Fairfax, Virginia, 미국, 22031
- Virginia Cancer Specialists, PC
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Washington
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Seattle, Washington, 미국, 98109
- University of Washington
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Vancouver, Washington, 미국, 98684
- Northwest Cancer Specialists, P.C.
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Yakima, Washington, 미국, 98902
- Yakima Valley Memorial Hospital, North Star Lodge
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Barcelona, 스페인, 08035
- Hospital Universitario Vall d'Hebron
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Madrid, 스페인, 28034
- Hospital Universitario Ramon y Cajal
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Livorno, 이탈리아, 57124
- Ospedale Civile di Livorno
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Hong Kong, 홍콩
- Queen Mary Hospital
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New Territories
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Hong Kong, New Territories, 홍콩
- Prince of Wales Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Erlotinib Mono-Therapy
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Erlotinib will be administered once a day
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실험적: Rociletinib Mono-Therapy
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Rociletinib will be administered twice daily
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
기간: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months
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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.
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Cycle 1 Day 1 to End of Treatment, up to approximately 35 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Confirmed Response Rate
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 11월 1일
기본 완료 (실제)
2017년 6월 28일
연구 완료 (실제)
2017년 6월 28일
연구 등록 날짜
최초 제출
2014년 6월 30일
QC 기준을 충족하는 최초 제출
2014년 7월 7일
처음 게시됨 (추정)
2014년 7월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 5월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 4월 29일
마지막으로 확인됨
2019년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
비소세포폐암에 대한 임상 시험
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Taichung Veterans General Hospital완전한심장 독성 | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung) | 의약품 관련 부작용 및 이상반응 (MeSH 용어) | Egfr 티로신 키나아제 억제제대만
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Fondazione del Piemonte per l'Oncologia모병유방암 | 난소 암 | 대장암 | 흑색종(피부암) | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung)이탈리아
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Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국
Erlotinib Mono-Therapy에 대한 임상 시험
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Johns Hopkins University아직 모집하지 않음
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Baskent University아직 모집하지 않음경요도 절제술(TUR) 증후군
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Foundation University Islamabad모병
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Fidec CorporationBill and Melinda Gates Foundation완전한예방 접종 후 이상 반응