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)

Détails de l’essai

Phase 3

Phase
Sexe(s)
18+

Tranche d’âge
47

Site(s)
En Recrutement

Options de traitement

Bras de l’étude

INTERVENTION ASSIGNÉE

Experimental: Arm A

Drug: Repotrectinib

Active Comparator: Arm B

Drug: Crizotinib

Principaux critères d’éligibilité

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

Résumé imprimable

Détails de l’essai

Options de traitement

Principaux critères d’éligibilité