REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis

ConditionsNSCLC Brain Metastases ROS1 Gene Rearrangement

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMedSIR

About this trial

REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene.

Eligibility criteria

Qualifiers

Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.

Female or male patients ≥ 18 years of age at the time of signing ICF.

Patients must be capable to swallow capsules intact (without chewing, crushing, or opening).

Histologically documented NSCLC.

Disqualifiers

Major surgery within four weeks of the start of treatment.

Type I leptomeningeal disease per ESMO-EANO guidelines.

Have received prior radiotherapy within two weeks before the first dose of Study treatment (four weeks in case of radiation therapy of the central nervous system). Participants must have recovered from all radiation-related toxicities, not require steroids, and not have had radiation pneumonitis.

Treatment with approved or investigational cancer therapy within14 days prior to initiation of Study treatment.