Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Randomized, Open-label, Multicenter, Phase 3 Trial of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).
Status | Recruiting |
Enrollment | 230 |
Est. completion date | January 27, 2031 |
Est. primary completion date | February 26, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC - Participant has a ROS1 gene rearrangement/fusion as detected by a local test. - At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator. - Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC - Up to 1 prior line of systemic treatment for NSCLC is permitted - ECOG Performance Status = 2 Exclusion Criteria: - Symptomatic brain metastases or symptomatic leptomeningeal involvement. - History of previous cancer requiring therapy within the previous 2 years, except for NSCLC under study, squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected. - Known tumor targetable co-mutations or rearrangements - Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment) Note: Other protocol-defined inclusion/exclusion criteria apply |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Italiano de Buenos Aires | ABB | Ciudad Autónoma De Buenos Aires |
Argentina | Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) | Buenos Aires | |
Argentina | Local Institution - 0207 | Buenos Aires | |
Argentina | Hospital Británico de Buenos Aires | Ciudad autónoma de Buenos Aires | Buenos Aires |
Argentina | Instituto Alexander Fleming | Ciudad Autónoma de Buenos Aires | Buenos Aires |
Argentina | Instituto Oncológico de Córdoba | Córdoba | |
Austria | Klinik Floridsdorf | Wien | |
Brazil | Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | São Paulo |
Brazil | Hospital Luxemburgo | Belo Horizonte | Minas Gerais |
Brazil | Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa | Porto Alegre | Rio Grande Do Sul |
Brazil | Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande Do Sul |
Brazil | Grupo Oncoclinicas Botafogo | Rio de Janeiro | |
Brazil | Hospital São Lucas de Copacabana | Rio de Janeiro | |
Brazil | Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | São Paulo |
Brazil | Hospital Paulistano | Sao Paulo | São Paulo |
Brazil | Local Institution - 0209 | Sao Paulo | São Paulo |
Brazil | Instituto D'Or de Pesquisa e Ensino (IDOR) | São Paulo | |
Brazil | Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo | |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Canada | Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec | Trois-Rivières | Quebec |
Chile | FALP | Santiago | Región Metropolitana De Santiago |
Chile | Oncocentro Apys | Viña del Mar | Valparaíso |
China | Beijing Cancer hospital | Beijing | Beijing |
China | Jilin Cancer Hospital | Changchun | Jilin |
China | Hunan Province People'S Hospital | Changsha | Hunan |
China | Local Institution - 0165 | Changsha | Hunan |
China | Local Institution - 0170 | Chengdu | Sichuan |
China | West China Hospital, Sichuan University | Chengdu | Sichuan |
China | Army Medical Center of PLA | Chongqing | Chongqing |
China | Local Institution - 0192 | Fuzhou | Fujian |
China | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
China | Local Institution - 0206 | Hangzhou | Zhejiang |
China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
China | Local Institution - 0171 | Harbin | Heilongjiang |
China | Shandong Cancer Hospital | Jinan | Shandong |
China | Local Institution - 0204 | Kunming | Yunnan |
China | Local Institution - 0205 | Linyi | Shandong |
China | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
China | Jiangsu Province Hospital Of Chinese Medicine | Nanjing | Jiangsu |
China | The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi |
China | Local Institution - 0179 | Shanghai | Shanghai |
China | Shanghai Chest Hospital | Shanghai | Shanghai |
China | Local Institution - 0203 | Wuhan | Hubei |
China | Hubei Cancer Hospital | Wuhan Shi | Hubei |
China | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
China | The First Affiliated hospital of Xiamen University | Xiamen | Fujian |
China | Henan Cancer Hospital | Zhengzhou | Henan |
France | Centre Georges François Leclerc | Dijon | Côte-d'Or |
France | Chu Grenoble Alpes | La Tronche | Isère |
France | Hopitaux Universitaires Paris Centre-Hopital Cochin | Paris | |
France | CHU Bordeaux Haut-Leveque | Pessac | Aquitaine |
France | Centre Hospitalier Lyon Sud | Pierre-Bénite | Rhône |
France | Hopital Charles Nicolle C H U Rouen | Rouen | Haute-Normandie |
France | Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes | Saint-Herblain | Loire-Atlantique |
France | Nouvel Hôpital Civil (NHC) | Strasbourg | Alsace |
Germany | Evangelische Lungenklinik Berlin | Berlin | |
Germany | Universitaetsklinikum Carl Gustav Carus Dresden | Dresden | |
Germany | Klinikum Esslingen | Esslingen | Baden-Württemberg |
Germany | Asklepios Klinik Gauting GmbH | Gauting | |
Germany | Lungenfachklinik Immenhausen | Immenhausen | |
Germany | Universitaetsklinikum Koeln | Köln | |
Germany | Marienhaus Klinikum Mainz | Mainz | |
Germany | Pius Hospital Oldenburg | Oldenburg | Niedersachsen |
Germany | Klinikum Würzburg Mitte | Wuerzburg | Bayern |
Greece | Thoracic General Hospital of Athens "I Sotiria" | Athens | Attikí |
Greece | Attikon General University Hospital | Chaidari | Attikí |
Greece | University Hospital of Patras | Patras | Acha?a |
Greece | Theagenio Hospital | Thessaloniki | Kentrikí Makedonía |
Hungary | Local Institution - 0135 | Budapest | |
India | Local Institution - 0102 | Ahmedabad | Gujarat |
India | Local Institution - 0118 | Ahmedabad | Gujarat |
India | Local Institution - 0082 | Bengaluru | Karnataka |
India | Local Institution - 0117 | Gurgaon | Haryana |
India | Local Institution - 0044 | Gurugram | Haryana |
India | Local Institution - 0220 | Hyderabad | Telangana |
India | Local Institution - 0048 | Mumbai | Maharashtra |
India | Local Institution - 0065 | Mumbai | Maharashtra |
India | Local Institution - 0076 | New Delhi | Delhi |
India | Local Institution - 0218 | New Delhi | Delhi |
India | Local Institution - 0045 | Pune | Maharashtra |
India | Local Institution - 0049 | Pune | Maharashtra |
India | Local Institution - 0219 | Thiruvananthapuram | Kerala |
Italy | Cro-Irccs | Aviano | |
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardia |
Italy | Fondazione IRCCS San Gerardo dei Tintori | Monza | Lombardia |
Italy | A.O.R.N. Ospedale dei Colli - Monaldi V. | Naples | Napoli |
Italy | Istituto Nazionale Tumori Regina Elena | Rome | Roma |
Japan | Local Institution - 0198 | Bunkyo ku | Tokyo |
Japan | National Hospital Organization Kyushu Cancer Center | Fukuoka | |
Japan | National Cancer Center Hospital East | Kashiwa | Chiba |
Japan | National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime |
Japan | Nagoya University Hospital | Nagoya | Aichi |
Japan | Osaka City General Hospital | Osaka | |
Japan | Osaka International Cancer Institute | Osaka | |
Japan | Hokkaido University Hospital | Sapporo | Hokkaido |
Japan | Sendai Kousei Hospital | Sendai | Miyagi |
Japan | Tokyo Metropolitan Police Hospital | Tokyo | |
Japan | Kanagawa cancer center | Yokohama | Kanagawa |
Japan | Tottori University Hospital | Yonago | Tottori |
Korea, Republic of | Chungbuk National University Hospital | Cheongju-si | Chungcheongbuk-do [Chungbuk] |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Kyonggi-do |
Korea, Republic of | Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] |
Korea, Republic of | Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | Seoul-teukbyeolsi [Seoul] |
Netherlands | Local Institution - 0216 | Amsterdam | Noord-Holland |
Netherlands | Local Institution - 0215 | Groningen | |
Poland | Instytut Genetyki i Immunologii GENIM | Lublin | Lubelskie |
Poland | Warminsko - Mazurskie Centrum Chorób Pluc w Olsztynie | Olsztyn | Warminsko-mazurskie |
Romania | Institutul Oncologic Bucuresti | Bucharest | Bucure?ti |
Romania | Centrul medical Focus | Bucure?ti | |
Romania | Institutul Oncologic Cluj | Cluj | |
Romania | Centrul de Oncologie "Sfântul Nectarie" | Craiova | Dolj |
Romania | S.C. Centrul de Oncologie Euroclinic S.R.L. | Ia?i | |
Spain | CHUAC-Hospital Teresa Herrera | A Coruña | A Coruña [La Coruña] |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] |
Spain | Hospital Universitario 12 de Octubre | Madrid | Madrid, Comunidad De |
Spain | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid, Comunidad De |
Spain | H.R.U Málaga - Hospital General | Málaga | |
Spain | CHUS - Hospital Clinico Universitario | Santiago de Compostela | A Coruña [La Coruña] |
Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
Spain | Hospital Universitari i Politecnic La Fe | València | |
Switzerland | Kantonspital Baden | Baden | Aargau |
Turkey | Local Institution - 0088 | Adana | |
Turkey | Local Institution - 0084 | Ankara | |
Turkey | Local Institution - 0083 | Istanbul | |
Turkey | Local Institution - 0097 | Istanbul | |
Turkey | Local Institution - 0085 | Sakarya | |
Turkey | Local Institution - 0087 | Stanbul | Istanbul |
Turkey | Local Institution - 0086 | Yenimahalle | Ankara |
United States | Local Institution - 0136 | Augusta | Georgia |
United States | Local Institution - 0075 | Boston | Massachusetts |
United States | Local Institution - 0201 | Boston | Massachusetts |
United States | Local Institution - 0217 | Brooklyn | New York |
United States | Local Institution - 0221 | Des Moines | Iowa |
United States | Local Institution - 0061 | Milwaukee | Wisconsin |
United States | Local Institution - 0210 | Mineola | New York |
United States | Laura and Isaac Perlmutter Cancer Center | New York | New York |
United States | Local Institution - 0127 | Syracuse | New York |
United States | Local Institution - 0214 | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Zai Lab (Shanghai) Co., Ltd. |
United States, Argentina, Austria, Brazil, Canada, Chile, China, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Republic of, Netherlands, Poland, Romania, Spain, Switzerland, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 64 months | ||
Secondary | Overall Survival (OS) | Up to 87 months | ||
Secondary | Overall Response Rate (ORR) as per BICR according to RECIST v1.1 | Up to 64 months | ||
Secondary | ORR as per Investigator according to RECIST v1.1 | Up to 64 months | ||
Secondary | Duration of Response (DOR) as per BICR according to RECIST v1.1 | Up to 64 months | ||
Secondary | DOR as per Investigator according to RECIST v1.1 | Up to 64 months | ||
Secondary | Time to Response (TTR) as per BICR according to RECIST v1.1 | Up to 64 months | ||
Secondary | TTR as per Investigator according to RECIST v1.1 | Up to 64 months | ||
Secondary | PFS as per Investigator according to RECIST v1.1 | Up to 64 months | ||
Secondary | Time to intracranial progressions as per BICR according to RECIST v1.1 | Up to 64 months | ||
Secondary | Number of participants with Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study intervention discontinuation, and drug-related AEs | Up to 30 days after last dose | ||
Secondary | Number of deaths | Up to 30 days after last dose | ||
Secondary | Number of participants without at least a 3-point change in the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) total score | Up to 30 days after last dose |
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