A study with Repotrectinib compared to Crizotinib in participants with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who are tyrosine kinase inhibitor (TKI)-naive (TRIDENT-3)
Summary description of the study
CA1271030 is a randomized (study participants are assigned to a treatment at random, like flipping a coin), open-label (both participants and the study physician know whether they are receiving the experimental or standard treatment) phase 3 (late-phase) study designed to show that the administered treatment is not worse than the current standard treatment in stopping or slowing ROS1-positive non-small cell lung cancer (NSCLC). Approximately 230 eligible participants will be randomized in a 1:1 ratio to receive either the experimental treatment (Repotrectinib) or Crizotinib. Treatment will continue until disease progression per BICR assessment according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), until death occurs, unacceptable toxicity, loss to follow-up, withdrawal of consent, or termination of the study by the sponsor, whichever occurs first.
(BASEC)
Intervention under investigation
- One group receives Repotrectinib at a fixed dose on fixed days
- One group receives Crizotinib at a fixed dose on fixed days
(BASEC)
Disease under investigation
Non-small cell lung cancer
(BASEC)
• Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC • Participants with ROS1 gene rearrangement/fusion, demonstrated by local testing • At least one measurable lesion per RECIST v1.1 in the investigator's assessment • Participants must not have been pre-treated with TKIs that showed efficacy in ROS1-positive NSCLC • Up to 1 prior systemic therapy line for NSCLC is allowed • ECOG performance status ≤ 2 (BASEC)
Exclusion criteria
• Symptomatic brain metastases or symptomatic leptomeningeal involvement • History of malignancies requiring therapy within the last 2 years, except for the NSCLC being studied in this trial, a squamous cell or basal cell carcinoma of the skin, or a completely resected in situ carcinoma • Known tumor-directed co-mutations or rearrangements • Clinically significant cardiovascular disease (either active or within 6 months prior to study entry) (BASEC)
Trial sites
Other
(BASEC)
Baden
(BASEC)
Sponsor
Bristol-Myers Squibb Services Unlimited Company Bristol Myers Squibb SA
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. Dr. Sacha Rothschild
+41 61 2655074
Sacha.rothschild@clutterksb.chKantonsspital Baden AG Onkologie Im Ergel 1
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
07.12.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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) (BASEC)
Academic title
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Public title
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Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
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Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available