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)
2019年4月29日 更新者：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.
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (実際)
100
段階
- フェーズ2
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama at Birmingham
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California
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Burbank、California、アメリカ、91505
- East Valley Hematology and Oncology Medical Group, Inc.
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Duarte、California、アメリカ、91010
- City of Hope
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Fountain Valley、California、アメリカ、92708
- Compassionate Cancer Care Medical Group, Inc.
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Fullerton、California、アメリカ、92835-3825
- St. Joseph Heritage Healthcare
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La Jolla、California、アメリカ、92093-0698
- UC San Diego Moores Cancer Center
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Los Angeles、California、アメリカ、90089
- University of Southern California, Norris Comprehensive Cancer Center
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Sacramento、California、アメリカ、95816
- Sutter Medical Group
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San Francisco、California、アメリカ、94115
- University of California San Francisco
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Santa Barbara、California、アメリカ、93105
- Sansum Clinic
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Santa Maria、California、アメリカ、93454
- Central Coast Medical Oncology Corporation
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Santa Monica、California、アメリカ、90404
- UCLA Medical Center
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Whittier、California、アメリカ、90603
- The Oncology Institute of Hope and Innovation
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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado Cancer Center
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District of Columbia
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Washington、District of Columbia、アメリカ、20007
- Georgetown University Medical Center
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Florida
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Fleming Island、Florida、アメリカ、32003
- Cancer Specialists of North Florida
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Fort Myers、Florida、アメリカ、33916
- Florida Cancer Specialists and Research Institute
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Miami、Florida、アメリカ、33176
- Advanced Medical Specialties
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Orlando、Florida、アメリカ、32804
- Florida Hospital Cancer Institute
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Saint Petersburg、Florida、アメリカ、33705
- Florida Cancer Specialists
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Weston、Florida、アメリカ、33331
- Cleveland Clinic Florida
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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Chicago、Illinois、アメリカ、60612
- University of Illinois Cancer Center
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Niles、Illinois、アメリカ、60714
- Illinois Cancer Specialists
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Maryland
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Baltimore、Maryland、アメリカ、21237
- Harry and Jeanette Weinberg Cancer Institute at Franklin Square
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Bethesda、Maryland、アメリカ、20889
- Walter Reed Army Institute of Research
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Michigan
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Detroit、Michigan、アメリカ、48201
- Barbara Ann Karmanos Cancer Institute
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Nebraska
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Omaha、Nebraska、アメリカ、68130
- Oncology Hematology West PC
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Nevada
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Henderson、Nevada、アメリカ、89014
- Comprehensive Cancer Centers of Nevada
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New Jersey
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East Brunswick、New Jersey、アメリカ、08816
- Regional Cancer Care Associates, LLC
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Morristown、New Jersey、アメリカ、07962
- Regional Cancer Care Associates
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New York
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Bronx、New York、アメリカ、10461
- Montefiore Medical Center
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Buffalo、New York、アメリカ、14263
- Roswell Park Cancer Institute
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke University Medical Center
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Ohio
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Cincinnati、Ohio、アメリカ、45267
- University of Cincinnati Medical Center
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic
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Cleveland、Ohio、アメリカ、44106
- University Hospitals Case Medical Center
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Oregon
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Portland、Oregon、アメリカ、97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- Thomas Jefferson University Hospital
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Hollings Cancer Center
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Tennessee
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Chattanooga、Tennessee、アメリカ、37404
- Tennessee Oncology, PLLC
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Nashville、Tennessee、アメリカ、37203
- Tennessee Oncology, PLLC
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Nashville、Tennessee、アメリカ、37212-3505
- USC/Norris Comprehensive Cancer Center
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Texas
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Austin、Texas、アメリカ、78745
- Texas Oncology, PA
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Beaumont、Texas、アメリカ、77702
- Texas Oncology-Beaumont
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Bedford、Texas、アメリカ、76022
- Texas Oncology, P.A.
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Dallas、Texas、アメリカ、75390-8852
- University of Texas Southwestern Medical Center
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Houston、Texas、アメリカ、77030
- Houston Methodist Cancer Center
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Houston、Texas、アメリカ、77030
- The University of Texas - MD Anderson Cancer Center
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Plano、Texas、アメリカ、75075-7753
- Texas Oncology-Plano East
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Virginia
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Fairfax、Virginia、アメリカ、22031
- Virginia Cancer Specialists, PC
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Washington
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Seattle、Washington、アメリカ、98109
- University of Washington
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Vancouver、Washington、アメリカ、98684
- Northwest Cancer Specialists, P.C.
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Yakima、Washington、アメリカ、98902
- Yakima Valley Memorial Hospital, North Star Lodge
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Livorno、イタリア、57124
- Ospedale Civile di Livorno
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Barcelona、スペイン、08035
- Hospital Universitario Vall d'Hebron
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Madrid、スペイン、28034
- Hospital Universitario Ramon Y Cajal
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Berlin、ドイツ
- Evangelische Lungenklinik Berlin
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Bayern
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Gauting、Bayern、ドイツ、82131
- Asklepios Fachkliniken München-Gauting
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Niedersachsen
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Oldenburg、Niedersachsen、ドイツ、26121
- Pius Hospital Oldenburg
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Nordrhein-Westfalen
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Köln、Nordrhein-Westfalen、ドイツ、50937
- Universitätsklinikum Köln
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Rheinland-Pfalz
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Mainz、Rheinland-Pfalz、ドイツ、55131
- Katholisches Klinikum Mainz, Sankt Hildegardis-Krankenhaus
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Taichung、台湾、40705
- Taichung Veterans General Hospital
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Taipei、台湾、11217
- Taipei Veterans General Hospital
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Taoyuan、台湾、33305
- Chang Gung Memorial Hospital LinKou
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Busan、大韓民国、602-715
- Dong-A University Hospital
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Incheon、大韓民国、400-711
- Inha University Hospital
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Seongnam-si、大韓民国、463-707
- Seoul National University Bundang Hospital
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Seoul、大韓民国、135-710
- Samsung Medical Center
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Seoul、大韓民国、138-736
- Asan Medical Center
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Seoul、大韓民国、120-752
- Severance Hospital, Yonsei University Health System
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Suwon、大韓民国、442-723
- The Catholic University of Korea Saint Vincent's Hospital
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Hong Kong、香港
- Queen Mary Hospital
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New Territories
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Hong Kong、New Territories、香港
- Prince of Wales Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Erlotinib Mono-Therapy
|
Erlotinib will be administered once a day
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実験的：Rociletinib Mono-Therapy
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Rociletinib will be administered twice daily
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Confirmed Response Rate
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年11月1日
一次修了 (実際)
2017年6月28日
研究の完了 (実際)
2017年6月28日
試験登録日
最初に提出
2014年6月30日
QC基準を満たした最初の提出物
2014年7月7日
最初の投稿 (見積もり)
2014年7月10日
学習記録の更新
投稿された最後の更新 (実際)
2019年5月7日
QC基準を満たした最後の更新が送信されました
2019年4月29日
最終確認日
2019年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
非小細胞肺がんの臨床試験
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Taichung Veterans General Hospital完了心毒性 | 非小細胞肺癌（MeSH用語：Carcinoma, Non-Small-Cell Lung） | 薬物関連の副作用および有害反応（MeSH用語） | EGFRチロシンキナーゼ阻害剤台湾
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Erlotinib Mono-Therapyの臨床試験
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Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
-
Universitätsklinikum Hamburg-Eppendorf完了
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Universidad Rey Juan Carlos完了