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)

NCT06140836 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CA127-1030U1111-1292-0487
• Study Type: interventional
• Target: 190
• Locations: 21 countries
• Sites: 122

Brief 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).

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

TKI-naïve; ROS1; NSCLC; ROS1-positive non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Up to approximately 41 months

Secondary Outcomes (12)

• Overall Survival (OS)

  Up to approximately 41 months

• Overall Response Rate (ORR) as per BICR according to RECIST v1.1

  Up to approximately 41 months

• ORR as per Investigator according to RECIST v1.1

  Up to approximately 41 months

• Duration of Response (DOR) as per BICR according to RECIST v1.1

  Up to approximately 41 months

• DOR as per Investigator according to RECIST v1.1

  Up to approximately 41 months

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Repotrectinib

Arm B

ACTIVE COMPARATOR

Drug: Crizotinib

Interventions

Repotrectinib DRUG

Specified dose on specified days

Also known as: BMS-986472

Arm A

Crizotinib DRUG

Specified dose on specified days

Also known as: Xalkori

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Zai Lab (Shanghai) Co., Ltd.: collaborator

Study Sites (122)

Local Institution - 0221

Des Moines, Iowa, 50309, United States

Location

Local Institution - 0075

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0201

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0210

Mineola, New York, 11501, United States

Location

Local Institution - 0134

New York, New York, 10016, United States

Location

Local Institution - 0214

Tacoma, Washington, 98405, United States

Location

Local Institution - 0092

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280, Argentina

Location

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

Location

Local Institution - 0091

ABB, Buenos Aires F.D., C1199ABB, Argentina

Location

Local Institution - 0106

Buenos Aires, 1431, Argentina

Location

Local Institution - 0207

Buenos Aires, C1417DTB, Argentina

Location

Local Institution - 0093

Córdoba, 5000, Argentina

Location

Local Institution - 0041

Vienna, 1210, Austria

Location

Local Institution - 0073

Belo Horizonte, Minas Gerais, 30380-490, Brazil

Location

Local Institution - 0033

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Local Institution - 0034

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Local Institution - 0029

Barretos, São Paulo, 14784400, Brazil

Location

Local Institution - 0037

São José do Rio Preto, São Paulo, 15090000, Brazil

Location

Local Institution - 0209

São Paulo, São Paulo, 01308-060, Brazil

Location

Local Institution - 0147

São Paulo, São Paulo, 01321-001, Brazil

Location

Local Institution - 0098

Rio de Janeiro, 22061-080, Brazil

Location

Local Institution - 0108

Rio de Janeiro, 22250-905, Brazil

Location

Local Institution - 0032

São Paulo, 01401-002, Brazil

Location

Local Institution - 0114

São Paulo, 05652-900, Brazil

Location

Local Institution - 0002

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0123

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Local Institution - 0096

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Fundacion Arturo Lopez Perez (FALP)

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Local Institution - 0168

Beijing, Beijing Municipality, 100142, China

Location

Local Institution - 0185

Chongqing, Chongqing Municipality, 400042, China

Location

Local Institution - 0169

Xiamen, Fujian, 361003, China

Location

Local Institution - 0180

Guangzhou, Guangdong, 510120, China

Location

Local Institution - 0194

Nanning, Guangxi, 530000, China

Location

Local Institution - 0171

Harbin, Heilongjiang, 150000, China

Location

Local Institution - 0166

Zhengzhou, Henan, 450003, China

Location

Local Institution - 0181

Wuhan, Hubei, 430079, China

Location

Local Institution - 0184

Changsha, Hunan, 410000, China

Location

Local Institution - 0193

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0202

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0178

Changchun, Jilin, 130012, China

Location

Local Institution - 0183

Xi'an, Shaanxi, 710061, China

Location

Local Institution - 0186

Jinan, Shandong, 250000, China

Location

Local Institution - 0164

Shanghai, Shanghai Municipality, 200030, China

Location

Local Institution - 0179

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0177

Chengdu, Sichuan, 610044, China

Location

Local Institution - 0175

Hangzhou, Zhejiang, 310022, China

Location

Local Institution - 0059

Strasbourg, Alsace, 67091, France

Location

Local Institution - 0055

Pessac, Aquitaine, 33600, France

Location

Local Institution - 0109

Dijon, Côte-d'Or, 21079, France

Location

Local Institution - 0057

Rouen, Haute-Normandie, 76031, France

Location

Local Institution - 0058

La Tronche, Isère, 38700, France

Location

Local Institution - 0189

Saint-Herblain, Loire-Atlantique, 44800, France

Location

Local Institution - 0060

Pierre-Bénite, Rhône, 69310, France

Location

Local Institution - 0056

Paris, 75014, France

Location

Klinikum Esslingen

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

Location

Klinikum Würzburg Mitte

Würzburg, Bavaria, 97074, Germany

Location

Local Institution - 0074

Oldenburg, Lower Saxony, 26121, Germany

Location

Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

Location

Universitaetsklinikum Koeln

Cologne, 50937, Germany

Location

Local Institution - 0035

Dresden, 01307, Germany

Location

Asklepios Klinik Gauting GmbH

Gauting, 82131, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

Marienhaus Klinikum Mainz

Mainz, 55131, Germany

Location

Local Institution - 0154

Pátrai, Achaḯa, 26504, Greece

Location

Local Institution - 0153

Athens, Attikí, 115 27, Greece

Location

Local Institution - 0155

Chaïdári, Attikí, 124 62, Greece

Location

"Theagenio" Cancer Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía, 540 07, Greece

Location

Local Institution - 0135

Budapest, 1121, Hungary

Location

Local Institution - 0102

Ahmedabad, Gujarat, 380054, India

Location

Local Institution - 0118

Ahmedabad, Gujarat, 380060, India

Location

Local Institution - 0044

Gurugram, Haryana, 122001, India

Location

Local Institution - 0082

Bengaluru, Karnataka, 560017, India

Location

Local Institution - 0045

Pune, Maharashtra, 411001, India

Location

Local Institution - 0049

Pune, Maharashtra, 411004, India

Location

Local Institution - 0218

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Local Institution - 0076

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Local Institution - 0151

Aviano, Friuli Venezia Giulia, 33081, Italy

Location

Local Institution - 0152

Milan, Lombardy, 20133, Italy

Location

Local Institution - 0149

Monza, Lombardy, 20900, Italy

Location

Local Institution - 0150

Naples, Napoli, 80131, Italy

Location

Local Institution - 0148

Rome, Roma, 00144, Italy

Location

Local Institution - 0190

Nagoya, Aichi-ken, 466-8560, Japan

Location

Local Institution - 0132

Kashiwa, Chiba, 277-8577, Japan

Location

Local Institution - 0174

Matsuyama, Ehime, 791-0280, Japan

Location

Local Institution - 0163

Sapporo, Hokkaido, 060-8648, Japan

Location

Local Institution - 0173

Yokohama, Kanagawa, 2418515, Japan

Location

Sendai Kosei Hospital

Sendai, Miyagi, 9800873, Japan

Location

Tokyo Metropolitan Komagome Hospital

Bunkyo Ku, Tokyo, 113-8677, Japan

Location

Local Institution - 0159

Yonago, Tottori, 683-8504, Japan

Location

Local Institution - 0195

Fukuoka, 811-1395, Japan

Location

Local Institution - 0160

Osaka, 534-0021, Japan

Location

Local Institution - 0167

Osaka, 541-8567, Japan

Location

Tokyo Metropolitan Police Hospital

Tokyo, 164-8541, Japan

Location

Local Institution - 0216

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Local Institution - 0187

Lublin, Lublin Voivodeship, 20-609, Poland

Location

Local Institution - 0196

Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland

Location

Local Institution - 0030

Bucharest, București, 013812, Romania

Location

Local Institution - 0066

Bucharest, București, 022328, Romania

Location

Local Institution - 0031

Craiova, Dolj, 200746, Romania

Location

Local Institution - 0122

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0067

Iași, 700106, Romania

Location

Local Institution - 0062

Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

Location

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Local Institution - 0063

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

Local Institution - 0141

A Coruña, A Coruña [La Coruña], 15006, Spain

Location

Local Institution - 0138

Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

Location

Local Institution - 0140

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0137

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Local Institution - 0139

Majadahonda, Madrid, Comunidad de, 28222, Spain

Location

Local Institution - 0142

Málaga, 29011, Spain

Location

Local Institution - 0144

Seville, 41013, Spain

Location

Local Institution - 0143

Valencia, 46026, Spain

Location

Kantonspital Baden

Baden, Canton of Aargau, 5404, Switzerland

Location

Local Institution - 0086

Yenimahalle, Ankara, 06200, Turkey (Türkiye)

Location

Local Institution - 0088

Adana, 01140, Turkey (Türkiye)

Location

Local Institution - 0084

Ankara, 06010, Turkey (Türkiye)

Location

Local Institution - 0087

Istanbul, 34214, Turkey (Türkiye)

Location

T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi

Istanbul, 34440, Turkey (Türkiye)

Location

Local Institution - 0083

Istanbul, 34899, Turkey (Türkiye)

Location

Local Institution - 0085

Sakarya, 0, Turkey (Türkiye)

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

repotrectinib; Crizotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 20, 2023
• Study Start: December 21, 2023
• Primary Completion: March 13, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

IN (8); CH (1); CL (2); US (6); AR (6); BR (11); CA (2); FR (8); PL (2); RO (5); CN (18); GR (4); DE (9); KR (5); NL (1); HU (1); JP (12); TU (7); ES (8); IT (5); AU (1)