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New lung cancer pill could beat current standard in ROS1-Positive patients

NCT ID NCT06140836

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares two targeted drugs, repotrectinib and crizotinib, in about 190 people with advanced ROS1-positive non-small cell lung cancer who have not had prior targeted therapy. The main goal is to see which drug better delays cancer growth. Participants may have had up to one prior line of chemotherapy. The study is active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: repotrectinib (a targeted drug) compared to crizotinib (a standard targeted drug)
What this could lead to: If repotrectinib works better, it could become a new first-choice treatment that helps people with this type of lung cancer live longer without their cancer growing.
What could go wrong: This is an early-stage comparison in a specific genetic subtype of lung cancer. Repotrectinib may not prove superior to crizotinib, and side effects could be similar or worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

"Theagenio" Cancer Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía, 540 07, Greece
Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Asklepios Klinik Gauting GmbH

Gauting, 82131, Germany
Evangelische Lungenklinik Berlin

Berlin, 13125, Germany
Fundacion Arturo Lopez Perez (FALP)

Santiago, Santiago Metropolitan, 7500921, Chile
Instituto Alexander Fleming

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

Baden, Canton of Aargau, 5404, Switzerland
Klinikum Esslingen

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany
Klinikum Würzburg Mitte

Würzburg, Bavaria, 97074, Germany
Local Institution - 0002

Toronto, Ontario, M5G 2M9, Canada
Local Institution - 0029

Barretos, São Paulo, 14784400, Brazil
Local Institution - 0030

Bucharest, Bucharest, 013812, Romania
Local Institution - 0031

Craiova, Dolj, 200746, Romania
Local Institution - 0032

São Paulo, 01401-002, Brazil
Local Institution - 0033

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Local Institution - 0034

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Local Institution - 0035

Dresden, 01307, Germany
Local Institution - 0037

São José do Rio Preto, São Paulo, 15090000, Brazil
Local Institution - 0041

Vienna, 1210, Austria
Local Institution - 0044

Gurugram, Haryana, 122001, India
Local Institution - 0045

Pune, Maharashtra, 411001, India
Local Institution - 0049

Pune, Maharashtra, 411004, India
Local Institution - 0055

Pessac, Aquitaine, 33600, France
Local Institution - 0056

Paris, 75014, France
Local Institution - 0057

Rouen, Haute-Normandie, 76031, France
Local Institution - 0058

La Tronche, Isère, 38700, France
Local Institution - 0059

Strasbourg, Alsace, 67091, France
Local Institution - 0060

Pierre-Bénite, Rhône, 69310, France
Local Institution - 0062

Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea
Local Institution - 0063

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Local Institution - 0066

Bucharest, Bucharest, 022328, Romania
Local Institution - 0067

Iași, 700106, Romania
Local Institution - 0073

Belo Horizonte, Minas Gerais, 30380-490, Brazil
Local Institution - 0074

Oldenburg, Lower Saxony, 26121, Germany
Local Institution - 0075

Boston, Massachusetts, 02114, United States
Local Institution - 0076

New Delhi, National Capital Territory of Delhi, 110085, India
Local Institution - 0082

Bengaluru, Karnataka, 560017, India
Local Institution - 0083

Istanbul, 34899, Turkey (Türkiye)
Local Institution - 0084

Ankara, 06010, Turkey (Türkiye)
Local Institution - 0085

Sakarya, 0, Turkey (Türkiye)
Local Institution - 0086

Yenimahalle, Ankara, 06200, Turkey (Türkiye)
Local Institution - 0087

Istanbul, 34214, Turkey (Türkiye)
Local Institution - 0088

Adana, 01140, Turkey (Türkiye)
Local Institution - 0091

ABB, Buenos Aires F.D., C1199ABB, Argentina
Local Institution - 0092

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280, Argentina
Local Institution - 0093

Córdoba, 5000, Argentina
Local Institution - 0096

Viña del Mar, Valparaiso, 2520598, Chile
Local Institution - 0098

Rio de Janeiro, 22061-080, Brazil
Local Institution - 0102

Ahmedabad, Gujarat, 380054, India
Local Institution - 0106

Buenos Aires, 1431, Argentina
Local Institution - 0108

Rio de Janeiro, 22250-905, Brazil
Local Institution - 0109

Dijon, Côte-d'Or, 21079, France
Local Institution - 0114

São Paulo, 05652-900, Brazil
Local Institution - 0118

Ahmedabad, Gujarat, 380060, India
Local Institution - 0122

Cluj-Napoca, 400015, Romania
Local Institution - 0123

Trois-Rivières, Quebec, G8Z 3R9, Canada
Local Institution - 0132

Kashiwa, Chiba, 277-8577, Japan
Local Institution - 0134

New York, New York, 10016, United States
Local Institution - 0135

Budapest, 1121, Hungary
Local Institution - 0137

Madrid, Madrid, Comunidad de, 28041, Spain
Local Institution - 0138

Santiago de Compostela, A Coruña [La Coruña], 15706, Spain
Local Institution - 0139

Majadahonda, Madrid, Comunidad de, 28222, Spain
Local Institution - 0140

Barcelona, Barcelona [Barcelona], 08035, Spain
Local Institution - 0141

A Coruña, A Coruña [La Coruña], 15006, Spain
Local Institution - 0142

Málaga, 29011, Spain
Local Institution - 0143

Valencia, 46026, Spain
Local Institution - 0144

Seville, 41013, Spain
Local Institution - 0147

São Paulo, São Paulo, 01321-001, Brazil
Local Institution - 0148

Rome, Roma, 00144, Italy
Local Institution - 0149

Monza, Lombardy, 20900, Italy
Local Institution - 0150

Naples, Napoli, 80131, Italy
Local Institution - 0151

Aviano, Friuli Venezia Giulia, 33081, Italy
Local Institution - 0152

Milan, Lombardy, 20133, Italy
Local Institution - 0153

Athens, Attikí, 115 27, Greece
Local Institution - 0154

Pátrai, Achaḯa, 26504, Greece
Local Institution - 0155

Chaïdári, Attikí, 124 62, Greece
Local Institution - 0159

Yonago, Tottori, 683-8504, Japan
Local Institution - 0160

Osaka, 534-0021, Japan
Local Institution - 0163

Sapporo, Hokkaido, 060-8648, Japan
Local Institution - 0164

Shanghai, Shanghai Municipality, 200030, China
Local Institution - 0166

Zhengzhou, Henan, 450003, China
Local Institution - 0167

Osaka, 541-8567, Japan
Local Institution - 0168

Beijing, Beijing Municipality, 100142, China
Local Institution - 0169

Xiamen, Fujian, 361003, China
Local Institution - 0171

Harbin, Heilongjiang, 150000, China
Local Institution - 0173

Yokohama, Kanagawa, 2418515, Japan
Local Institution - 0174

Matsuyama, Ehime, 791-0280, Japan
Local Institution - 0175

Hangzhou, Zhejiang, 310022, China
Local Institution - 0177

Chengdu, Sichuan, 610044, China
Local Institution - 0178

Changchun, Jilin, 130012, China
Local Institution - 0179

Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0180

Guangzhou, Guangdong, 510120, China
Local Institution - 0181

Wuhan, Hubei, 430079, China
Local Institution - 0183

Xi'an, Shaanxi, 710061, China
Local Institution - 0184

Changsha, Hunan, 410000, China
Local Institution - 0185

Chongqing, Chongqing Municipality, 400042, China
Local Institution - 0186

Jinan, Shandong, 250000, China
Local Institution - 0187

Lublin, Lublin Voivodeship, 20-609, Poland
Local Institution - 0189

Saint-Herblain, Loire-Atlantique, 44800, France
Local Institution - 0190

Nagoya, Aichi-ken, 466-8560, Japan
Local Institution - 0193

Nanjing, Jiangsu, 210029, China
Local Institution - 0194

Nanning, Guangxi, 530000, China
Local Institution - 0195

Fukuoka, 811-1395, Japan
Local Institution - 0196

Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland
Local Institution - 0201

Boston, Massachusetts, 02215, United States
Local Institution - 0202

Nanchang, Jiangxi, 330006, China
Local Institution - 0207

Buenos Aires, C1417DTB, Argentina
Local Institution - 0209

São Paulo, São Paulo, 01308-060, Brazil
Local Institution - 0210

Mineola, New York, 11501, United States
Local Institution - 0214

Tacoma, Washington, 98405, United States
Local Institution - 0216

Amsterdam, North Holland, 1081 HV, Netherlands
Local Institution - 0218

New Delhi, National Capital Territory of Delhi, 110029, India
Local Institution - 0221

Des Moines, Iowa, 50309, United States
Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany
Marienhaus Klinikum Mainz

Mainz, 55131, Germany
Sendai Kosei Hospital

Sendai, Miyagi, 9800873, Japan
Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea
Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi

Istanbul, 34440, Turkey (Türkiye)
Tokyo Metropolitan Komagome Hospital

Bunkyo Ku, Tokyo, 113-8677, Japan
Tokyo Metropolitan Police Hospital

Tokyo, 164-8541, Japan
Universitaetsklinikum Koeln

Cologne, 50937, Germany

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