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)
Résumé de l'étude
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 étudiée
- One group receives Repotrectinib at a fixed dose on fixed days
- One group receives Crizotinib at a fixed dose on fixed days
(BASEC)
Maladie en cours d'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)
Critères d'exclusion
• 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)
Lieu de l’étude
Autre
(BASEC)
Baden
(BASEC)
Sponsor
Bristol-Myers Squibb Services Unlimited Company Bristol Myers Squibb SA
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. Dr. Sacha Rothschild
+41 61 2655074
Sacha.rothschild@clutterksb.chKantonsspital Baden AG Onkologie Im Ergel 1
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
07.12.2023
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible