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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Patients may have active brain metastases with or without related symptoms.
✓. No indication for immediate local therapy (neurosurgery, brain radiotherapy) of brain metastases per local investigator.
✓. Type II leptomeningeal disease per European Association of Neuro-Oncology (EANO) - European Society for Medical Oncology (ESMO) Clinical Practice Guidelines are allowed.
✓. Patients with confirmed ROS1 rearrangement. Prior to study enrollment, patients must have had confirmation of ROS1 rearrangement, which should have been determined locally by a certified laboratory using methods such as fluorescent in situ hybridization (FISH), next generation sequencing (NGS), quantitative PCR (qPCR), or immunohistochemistry (IHC).
Exclusion criteria
✕. 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.
What they're measuring
1
Intracranial Objective Response Rate (IC-ORR)
Timeframe: From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 13 months.
✕. Treatment with approved or investigational cancer therapy within14 days prior to initiation of Study treatment.
✕. Any of the following cardiac criteria:
✕. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
✕. Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
✕. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.