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)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06140836Tipo: INTERVENTIONALInicio: 21 de dic de 2023Fin estimado: 15 de mar de 2027

Traducción no disponible, mostrando original

Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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)

Intervenciones

drug

Repotrectinib

Specified dose on specified days

drug

Crizotinib

Specified dose on specified days

Ubicaciones

Local Institution - 0092

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0091

ABB, Buenos Aires F.D., Argentina

Local Institution - 0106

Buenos Aires, Argentina

Local Institution - 0207

Buenos Aires, Argentina

Local Institution - 0093

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorZai Lab (Shanghai) Co., Ltd.

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