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AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT06140836

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)

A Phase 3 study testing Repotrectinib and Crizotinib in people with Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 122 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Repotrectinib and Crizotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
122 sitesin 21 countries
Study dates
21 Dec 2023to 15 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

122 sites in 21 countries.

122 sites in 21 countries

China18 sites

  • Local Institution - 0168

    Beijing, Beijing Municipality, 100142

  • Local Institution - 0178

    Changchun, Jilin, 130012

  • Local Institution - 0184

    Changsha, Hunan, 410000

  • Local Institution - 0177

    Chengdu, Sichuan, 610044

  • Local Institution - 0185

    Chongqing, Chongqing Municipality, 400042

  • Local Institution - 0180

    Guangzhou, Guangdong, 510120

  • Local Institution - 0175

    Hangzhou, Zhejiang, 310022

  • Local Institution - 0171

    Harbin, Heilongjiang, 150000

  • Local Institution - 0186

    Jinan, Shandong, 250000

  • Local Institution - 0202

    Nanchang, Jiangxi, 330006

  • Local Institution - 0193

    Nanjing, Jiangsu, 210029

  • Local Institution - 0194

    Nanning, Guangxi, 530000

  • Local Institution - 0164

    Shanghai, Shanghai Municipality, 200030

  • Local Institution - 0179

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0181

    Wuhan, Hubei, 430079

  • Local Institution - 0183

    Xi'an, Shaanxi, 710061

  • Local Institution - 0169

    Xiamen, Fujian, 361003

  • Local Institution - 0166

    Zhengzhou, Henan, 450003

Other trials in China

Japan12 sites

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo Ku, Tokyo, 113-8677

  • Local Institution - 0195

    Fukuoka, 811-1395

  • Local Institution - 0132

    Kashiwa, Chiba, 277-8577

  • Local Institution - 0174

    Matsuyama, Ehime, 791-0280

  • Local Institution - 0190

    Nagoya, Aichi-ken, 466-8560

  • Local Institution - 0160

    Osaka, 534-0021

  • Local Institution - 0167

    Osaka, 541-8567

  • Local Institution - 0163

    Sapporo, Hokkaido, 060-8648

  • Sendai Kosei Hospital

    Sendai, Miyagi, 9800873

  • Tokyo Metropolitan Police Hospital

    Tokyo, 164-8541

  • Local Institution - 0173

    Yokohama, Kanagawa, 2418515

  • Local Institution - 0159

    Yonago, Tottori, 683-8504

Other trials in Japan

Brazil11 sites

  • Local Institution - 0029

    Barretos, São Paulo, 14784400

  • Local Institution - 0073

    Belo Horizonte, Minas Gerais, 30380-490

  • Local Institution - 0033

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Local Institution - 0034

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution - 0098

    Rio de Janeiro, 22061-080

  • Local Institution - 0108

    Rio de Janeiro, 22250-905

  • Local Institution - 0037

    São José do Rio Preto, São Paulo, 15090000

  • Local Institution - 0209

    São Paulo, São Paulo, 01308-060

  • Local Institution - 0147

    São Paulo, São Paulo, 01321-001

  • Local Institution - 0032

    São Paulo, 01401-002

  • Local Institution - 0114

    São Paulo, 05652-900

Other trials in Brazil

Germany9 sites

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Local Institution - 0035

    Dresden, 01307

  • Klinikum Esslingen

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • Asklepios Klinik Gauting GmbH

    Gauting, 82131

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Marienhaus Klinikum Mainz

    Mainz, 55131

  • Local Institution - 0074

    Oldenburg, Lower Saxony, 26121

  • Klinikum Würzburg Mitte

    Würzburg, Bavaria, 97074

Other trials in Germany

France8 sites

  • Local Institution - 0109

    Dijon, Côte-d'Or, 21079

  • Local Institution - 0058

    La Tronche, Isère, 38700

  • Local Institution - 0056

    Paris, 75014

  • Local Institution - 0055

    Pessac, Aquitaine, 33600

  • Local Institution - 0060

    Pierre-Bénite, Rhône, 69310

  • Local Institution - 0057

    Rouen, Haute-Normandie, 76031

  • Local Institution - 0189

    Saint-Herblain, Loire-Atlantique, 44800

  • Local Institution - 0059

    Strasbourg, Alsace, 67091

Other trials in France

India8 sites

  • Local Institution - 0102

    Ahmedabad, Gujarat, 380054

  • Local Institution - 0118

    Ahmedabad, Gujarat, 380060

  • Local Institution - 0082

    Bengaluru, Karnataka, 560017

  • Local Institution - 0044

    Gurugram, Haryana, 122001

  • Local Institution - 0218

    New Delhi, National Capital Territory of Delhi, 110029

  • Local Institution - 0076

    New Delhi, National Capital Territory of Delhi, 110085

  • Local Institution - 0045

    Pune, Maharashtra, 411001

  • Local Institution - 0049

    Pune, Maharashtra, 411004

Other trials in India

Spain8 sites

  • Local Institution - 0141

    A Coruña, A Coruña [La Coruña], 15006

  • Local Institution - 0140

    Barcelona, Barcelona [Barcelona], 08035

  • Local Institution - 0137

    Madrid, Madrid, Comunidad de, 28041

  • Local Institution - 0139

    Majadahonda, Madrid, Comunidad de, 28222

  • Local Institution - 0142

    Málaga, 29011

  • Local Institution - 0138

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

  • Local Institution - 0144

    Seville, 41013

  • Local Institution - 0143

    Valencia, 46026

Other trials in Spain

Turkey (Türkiye)7 sites

  • Local Institution - 0088

    Adana, 01140

  • Local Institution - 0084

    Ankara, 06010

  • Local Institution - 0087

    Istanbul, 34214

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

    Istanbul, 34440

  • Local Institution - 0083

    Istanbul, 34899

  • Local Institution - 0085

    Sakarya, 0

  • Local Institution - 0086

    Yenimahalle, Ankara, 06200

Other trials in Turkey (Türkiye)

United States6 sites

  • Local Institution - 0075

    Boston, Massachusetts, 02114

  • Local Institution - 0201

    Boston, Massachusetts, 02215

  • Local Institution - 0221

    Des Moines, Iowa, 50309

  • Local Institution - 0210

    Mineola, New York, 11501

  • Local Institution - 0134

    New York, New York, 10016

  • Local Institution - 0214

    Tacoma, Washington, 98405

Other trials in United States

Argentina6 sites

  • Local Institution - 0091

    ABB, Buenos Aires F.D., C1199ABB

  • Local Institution - 0106

    Buenos Aires, 1431

  • Local Institution - 0207

    Buenos Aires, C1417DTB

  • Local Institution - 0092

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280

  • Instituto Alexander Fleming

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

  • Local Institution - 0093

    Córdoba, 5000

Other trials in Argentina

Italy5 sites

  • Local Institution - 0151

    Aviano, Friuli Venezia Giulia, 33081

  • Local Institution - 0152

    Milan, Lombardy, 20133

  • Local Institution - 0149

    Monza, Lombardy, 20900

  • Local Institution - 0150

    Naples, Napoli, 80131

  • Local Institution - 0148

    Rome, Roma, 00144

Other trials in Italy

Romania5 sites

  • Local Institution - 0030

    Bucharest, Bucharest, 013812

  • Local Institution - 0066

    Bucharest, Bucharest, 022328

  • Local Institution - 0122

    Cluj-Napoca, 400015

  • Local Institution - 0031

    Craiova, Dolj, 200746

  • Local Institution - 0067

    Iași, 700106

Other trials in Romania

South Korea5 sites

  • Local Institution - 0062

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

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 03722

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Local Institution - 0063

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

Other trials in South Korea

Greece4 sites

  • Local Institution - 0153

    Athens, Attikí, 115 27

  • Local Institution - 0155

    Chaïdári, Attikí, 124 62

  • Local Institution - 0154

    Pátrai, Achaḯa, 26504

  • "Theagenio" Cancer Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía, 540 07

Other trials in Greece

Canada2 sites

  • Local Institution - 0002

    Toronto, Ontario, M5G 2M9

  • Local Institution - 0123

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Chile2 sites

  • Fundacion Arturo Lopez Perez (FALP)

    Santiago, Santiago Metropolitan, 7500921

  • Local Institution - 0096

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Poland2 sites

  • Local Institution - 0187

    Lublin, Lublin Voivodeship, 20-609

  • Local Institution - 0196

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

Other trials in Poland

Austria1 site

  • Local Institution - 0041

    Vienna, 1210

Other trials in Austria

Hungary1 site

  • Local Institution - 0135

    Budapest, 1121

Other trials in Hungary

Netherlands1 site

  • Local Institution - 0216

    Amsterdam, North Holland, 1081 HV

Other trials in Netherlands

Switzerland1 site

  • Kantonspital Baden

    Baden, Canton of Aargau, 5404

Other trials in Switzerland

About this study

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).

Being tested
Repotrectinib, Crizotinib
Keywords
TKI-naïve, ROS1, NSCLC, ROS1-positive non-small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RepotrectinibDrug

    Also called BMS-986472

    Specified dose on specified days

  • CrizotinibDrug

    Also called Xalkori

    Specified dose on specified days

Study groups in NCT06140836
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Drug: Repotrectinib
Arm BActive comparatorNot described
Receives: Drug: Crizotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to approximately 41 months

Secondary outcomes (12)

  1. Overall Survival (OS)

    Measured: Up to approximately 41 months

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

    Measured: Up to approximately 41 months

  3. ORR as per Investigator according to RECIST v1.1

    Measured: Up to approximately 41 months

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

    Measured: Up to approximately 41 months

  5. DOR as per Investigator according to RECIST v1.1

    Measured: Up to approximately 41 months

  6. Time to Response (TTR) as per BICR according to RECIST v1.1

    Measured: Up to approximately 41 months

  7. TTR as per Investigator according to RECIST v1.1

    Measured: Up to approximately 41 months

  8. PFS as per Investigator according to RECIST v1.1

    Measured: Up to approximately 41 months

  9. Time to intracranial progressions as per BICR according to RECIST v1.1

    Measured: Up to approximately 41 months

  10. Number of participants with Adverse Events (AEs), Serious AEs (SAEs), AEs leading to study intervention discontinuation, and drug-related AEs

    Measured: Up to 30 days after last dose

  11. Number of deaths

    Measured: Up to 30 days after last dose

  12. Number of participants without at least a 3-point change in the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) total score

    Measured: Up to 30 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2023
  2. Study start21 Dec 2023
  3. Primary completion16 Feb 2027 (estimated)
  4. Study completion15 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06140836
Sponsor's protocol ID
CA127-1030
Other IDs
U1111-1292-0487
Status last verified
Sep 2026
First submitted
15 Nov 2023
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Repotrectinib and Crizotinib in people with Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 122 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in China, Japan, Brazil, Germany, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) as per Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to approximately 41 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06140836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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