A Study 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)
Launched by BRISTOL-MYERS SQUIBB · Nov 15, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The TRIDENT-3 clinical trial is studying two medications, repotrectinib and crizotinib, to see how effective and safe they are for treating patients with a specific type of lung cancer called ROS1-positive non-small cell lung cancer (NSCLC) that has either spread or is locally advanced. This study is designed for adults who have not previously received treatment with tyrosine kinase inhibitors (TKIs), which are a type of drug that targets cancer cells. The trial is currently recruiting participants aged 65 to 74 who have a confirmed diagnosis of NSCLC and a specific change in their ROS1 gene.
To be eligible for the trial, participants need to have at least one measurable tumor and cannot have symptoms from brain metastases (cancer that has spread to the brain). They should also not have had significant previous cancers or certain heart conditions. If you or someone you know meets these criteria and is interested in this trial, they can expect to receive either of the study medications and will be monitored closely for their response and any side effects. This trial is an important step in finding new treatment options for patients with this type of lung cancer.
Gender
ALL
Eligibility criteria
- 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
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
New York, New York, United States
Boston, Massachusetts, United States
Sapporo, Hokkaido, Japan
Syracuse, New York, United States
Dijon, , France
Kashiwa, Chiba, Japan
Osaka, , Japan
Sevilla, , Spain
New Delhi, Delhi, India
Augusta, Georgia, United States
Patras, , Greece
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Barcelona, , Spain
Seoul, , Korea, Republic Of
Nagoya, Aichi, Japan
Immenhausen, , Germany
Esslingen, , Germany
Matsuyama, Ehime, Japan
Madrid, , Spain
Porto Alegre, Rio Grande Do Sul, Brazil
Toronto, Ontario, Canada
Fukuoka, , Japan
Hangzhou, Zhejiang, China
Xi'an, Shaanxi, China
Berlin, , Germany
Seongnam, , Korea, Republic Of
Pierre Bénite, , France
Shanghai, Shanghai, China
Changchun, Jilin, China
Majadahonda, , Spain
Beijing, Beijing, China
Shanghai, Shanghai, China
Zhengzhou, Henan, China
Esslingen, Baden Württemberg, Germany
Nanchang, Jiangxi, China
Jinan, Shandong, China
Yokohama, Kanagawa, Japan
Guangzhou, Guangdong, China
Baden, , Switzerland
Osaka, , Japan
Xiamen, Fujian, China
Cheongju Si, , Korea, Republic Of
Nanning, Guangxi, China
Yonago, Tottori, Japan
Oldenburg, Niedersachsen, Germany
Jinan, Shandong, China
Istanbul, , Turkey
New York, New York, United States
Tokyo, , Japan
Chongqing, Chongqing, China
Baden, Aargau, Switzerland
Pune, Maharashtra, India
La Tronche, , France
Bunkyo Ku, Tokyo, Japan
Gurugram, Haryana, India
Seongnam, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Pierre Bénite, Rhône, France
São Paulo, , Brazil
València, , Spain
Nanjing, Jiangsu, China
Trois Rivières, Quebec, Canada
Craiova, Dolj, Romania
New Delhi, Delhi, India
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Köln, , Germany
Milan, Lombardia, Italy
Wien, , Austria
Dijon, Côte D'or, France
Barretos, São Paulo, Brazil
São José Do Rio Preto, São Paulo, Brazil
Dresden, , Germany
A Coruña, , Spain
Patras, Achaḯa, Greece
Rouen, Haute Normandie, France
Aviano, Friuli Venezia Giulia, Italy
Barcelona, Barcelona [Barcelona], Spain
Chengdu, Sichuan, China
A Coruña, A Coruña [La Coruña], Spain
Santiago De Compostela, A Coruña [La Coruña], Spain
Madrid, Madrid, Comunidad De, Spain
Mineola, New York, United States
Dresden, Sachsen, Germany
Amsterdam, Noord Holland, Netherlands
Strasbourg, Alsace, France
Saint Herblain, Loire Atlantique, France
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, São Paulo, Brazil
Pune, Maharashtra, India
Cheongju Si, Chungcheongbuk Do [Chungbuk], Korea, Republic Of
Chaidari, Attikí, Greece
Rio De Janeiro, , Brazil
La Tronche, Isère, France
Rio De Janeiro, , Brazil
Viña Del Mar, , Chile
Pessac, Aquitaine, France
Majadahonda, Madrid, Comunidad De, Spain
Budapest, , Hungary
Craiova, Dolj, Romania
Rome, Roma, Italy
Harbin, Heilongjiang, China
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Monza, Lombardia, Italy
Ankara, , Turkey
Adana, , Turkey
Viña Del Mar, Valparaíso, Chile
Paris, , France
Málaga, , Spain
Santiago De Compostela, , Spain
Gauting, , Germany
Sao Paulo, São Paulo, Brazil
București, , Romania
São José Do Rio Preto, São Paulo, Brazil
São Paulo, , Brazil
Montréal, Quebec, Canada
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Wuhan, Hubei, China
Nanchang, Jiangxi, China
Linyi, Shandong, China
Kunming, Shanghai, China
Hangzhou, Zhejiang, China
Köln, , Germany
Mainz, , Germany
Budapest, , Hungary
Aviano, , Italy
Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Matsuyama, Ehime, Japan
Sapporo, Hokkaido, Japan
Yokohama, Kanagawa, Japan
Sendai, Miyagi, Japan
Bunkyo Ku, Tokyo, Japan
Yonago, Tottori, Japan
Fukuoka, , Japan
Osaka, , Japan
Bucharest, București, Romania
Iași, , Romania
Yenimahalle, Ankara, Turkey
Stanbul, İstanbul, Turkey
Adana, , Turkey
Ankara, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Sakarya, , Turkey
Buenos Aires, , Argentina
Zhengzhou, Henan, China
Jinan, Shandong, China
Tokyo, , Japan
Craiova, Dolj, Romania
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Mineola, New York, United States
New York, New York, United States
Syracuse, New York, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Abb, Ciudad Autónoma De Buenos Aires, Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
Wien, , Austria
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Barretos, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Rio De Janeiro, , Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
Toronto, Ontario, Canada
Trois Rivières, Quebec, Canada
Viña Del Mar, Valparaíso, Chile
Beijing, Beijing, China
Chongqing, Chongqing, China
Fuzhou, Fujian, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Harbin, Heilongjiang, China
Zhengzhou, Henan, China
Wuhan Shi, Hubei, China
Changsha, Hunan, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Changchun, Jilin, China
Xi'an, Shaanxi, China
Jinan, Shangdong, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Strasbourg, Alsace, France
Pessac, Aquitaine, France
Dijon, Côte D'or, France
Rouen, Haute Normandie, France
La Tronche, Isère, France
Saint Herblain, Loire Atlantique, France
Pierre Bénite, Rhône, France
Paris, , France
Esslingen, Baden Württemberg, Germany
Wuerzburg, Bayern, Germany
Oldenburg, Niedersachsen, Germany
Dresden, Sachsen, Germany
Berlin, , Germany
Gauting, , Germany
Immenhausen, , Germany
Patras, Achaḯa, Greece
Athens, Attikí, Greece
Chaidari, Attikí, Greece
Thessaloniki, Kentrikí Makedonía, Greece
New Delhi, Delhi, India
Ahmedabad, Gujarat, India
Ahmedabad, Gujarat, India
Gurgaon, Haryana, India
Gurugram, Haryana, India
Bengaluru, Karnataka, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Pune, Maharashtra, India
Pune, Maharashtra, India
Milan, Lombardia, Italy
Monza, Lombardia, Italy
Naples, Napoli, Italy
Rome, Roma, Italy
Sendai, Miyagi, Japan
Osaka, , Japan
Cheongju Si, Chungcheongbuk Do [Chungbuk], Korea, Republic Of
Seongnam, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Lublin, Lubelskie, Poland
Olsztyn, Warmińsko Mazurskie, Poland
București, , Romania
Cluj, , Romania
A Coruña, A Coruña [La Coruña], Spain
Santiago De Compostela, A Coruña [La Coruña], Spain
Barcelona, Barcelona [Barcelona], Spain
Madrid, Madrid, Comunidad De, Spain
Majadahonda, Madrid, Comunidad De, Spain
Málaga, , Spain
Sevilla, , Spain
València, , Spain
Baden, , Switzerland
Mainz, , Germany
Abb, Ciudad Autónoma De Buenos Aires, Argentina
Changsha, Hunan, China
Sao Paulo, São Paulo, Brazil
Cluj, , Romania
Jinan, Shandong, China
Santiago, Región Metropolitana De Santiago, Chile
Wuerzburg, Bayern, Germany
Naples, Napoli, Italy
Bucharest, București, Romania
Augusta, Georgia, United States
Brooklyn, New York, United States
Milwaukee, Wisconsin, United States
Harbin, Heilongjiang, China
Wuhan Shi, Hubei, China
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
São Paulo, , Brazil
Amsterdam, Noord Holland, Netherlands
Groningen, , Netherlands
Lublin, Lubelskie, Poland
Iași, , Romania
Belo Horizonte, Minas Gerais, Brazil
Córdoba, , Argentina
Rouen, Haute Normandie, France
Hyderabad, Telangana, India
Thiruvananthapuram, Kerala, India
Olsztyn, Warmińsko Mazurskie, Poland
Thessaloniki, Kentrikí Makedonía, Greece
New Delhi, Delhi, India
Aviano, , Italy
Rio De Janeiro, , Brazil
Des Moines, Iowa, United States
Tacoma, Washington, United States
Athens, Attikí, Greece
Buenos Aires, , Argentina
Ahmedabad, Gujarat, India
Buenos Aires, , Argentina
Sendai, Miyagi, Japan
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Lembah Pantai, Wilayah Persekutuan Kuala Lumpur, Malaysia
Putrajaya, Wilayah Persekutuan Kuala Lumpur, Malaysia
Bucharest, Bucuresti, Romania
Thessaloniki, Kentrikí Makedonía, Greece
Lembah Pantai, Wilayah Persekutuan Kuala Lumpur, Malaysia
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Santiago, Región Metropolitana De Santiago, Chile
Istanbul, , Turkey
Bucharest, București, Romania
Istanbul, , Turkey
Ahmedabad, Gujarat, India
Bengaluru, Karnataka, India
Yenimahalle, Ankara, Turkey
Istanbul, , Turkey
Sakarya, , Turkey
Barretos, , Brazil
Sao Paulo, , Brazil
São José Do Rio Preto, , Brazil
Abb, , Argentina
Bucharest, , Romania
Chaidari, , Greece
Sao Paulo, , Brazil
Thessaloniki, , Greece
Santiago, , Chile
Athens, , Greece
Olsztyn, , Poland
Bucharest, , Romania
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported