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CA127-1030

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)
Source : Import from center

clinicaltrials.gov reference: NCT06140836
TKI-naïve
ROS1
NSCLC
ROS1-positive non-small cell lung cancer
Source : Import from center
Advanced
Metastatic
ROS1
Recruiment partially open
Last modification : 2025/07/24
Study type

Interventional

Experimental drug

PHASE3


Target population

Medical condition (targeted specialty)

Therapeutic area choices

Cancer stages

Advanced

Metastatic

Biomarker

ROS1

Participants profils

Participants gender(s)

ALL

Source : Import from center
Subjects aptitude

Selection criterias

Inclusion 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

Source : Import from center
Exclusion criteria

voir protocole p.64

Source : Import from center

Proposed Therapy or Intervention

Cohorts
Name Medical condition Treatment Recruitment status
Arm A Data not available Data not available
  • Unknown
  • Arm B Data not available Data not available
  • Unknown
  • Arm A
    Recruitment status
    unknown
    Arm B
    Recruitment status
    unknown
    Current data since : July 24, 2025 20:00

    Study description

    Study 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).

    Source : Import from center

    Locations

    Participating centers

      10 shown out of 83 centers
    • "THEAGENIO" CANCER HOSPITAL OF THESSALONIKI

      Thessaloniki

      KENTRIKÍ MAKEDONÍA, GREECE

      Local recruitment
      Recruiting status: OPEN
      Contact details for recruitment
      Local project contacts
      researchers:
    • CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DE LA MAURICIE-ET-DU-CENTRE-DU-QUÉBEC * **

      Trois-rivières

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: CLOSED
      click here for more information about this center
      Cohorts
      Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
      Data not available
      Current data since : January 27, 2025 00:20
    • CENTRE UNIVERSITAIRE DE SANTÉ MCGILL *

      Montréal

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: UPCOMING
      click here for more information about this center
      Cohorts
      Centre universitaire de santé McGill
      Data not available
      Current data since : December 23, 2023 00:31
    • A.O.R.N. OSPEDALE DEI COLLI - MONALDI V.

      Naples

      NAPOLI, ITALY

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:
    • ADANA MEDICAL PARK SEYHAN HASTANESI

      Adana

      TURKEY

      Local recruitment
      Recruiting status: OPEN
      Contact details for recruitment
      Local project contacts
    • ALL INDIA INSTITUTE OF MEDICAL SCIENCES

      New delhi

      DELHI, INDIA

      Local recruitment
      Recruiting status: OPEN
      Contact details for recruitment
      Local project contacts
      researchers:
    • AMSTERDAM UMC, LOCATIE VUMC

      Amsterdam

      NOORD-HOLLAND, NETHERLANDS

      Local recruitment
      Recruiting status: OPEN
      Contact details for recruitment
      Local project contacts
      researchers:
    • ASAN MEDICAL CENTER

      Seoul

      KOREA, KOREA, REPUBLIC OF

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:
    • ASKLEPIOS KLINIK GAUTING GMBH

      Gauting

      MUNICH, GERMANY

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:
    • ATTIKON GENERAL UNIVERSITY HOSPITAL

      Chaidari

      ATTIKÍ, GREECE

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:

    Last modification : July 24, 2025
    Current data since : 01 Aug 17:59
    Data source : clinicaltrials.gov, Nagano
    Nagano reference: MP-29-2024-752
    clinicaltrials.gov reference: NCT06140836