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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06140836
Other study ID # CA127-1030
Secondary ID U1111-1292-0487
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 21, 2023
Est. completion date January 27, 2031

Study information

Verified date June 2024
Source Bristol-Myers Squibb
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Repotrectinib
Specified dose on specified days
Crizotinib
Specified dose on specified days

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Bristol-Myers Squibb Zai Lab (Shanghai) Co., Ltd.

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  Canada,  Chile,  China,  France,  Germany,  Greece,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Romania,  Spain,  Switzerland,  Turkey, 

Outcome

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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