Actively Recruiting
REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis
Led by MedSIR · Updated on 2026-02-25
20
Participants Needed
16
Research Sites
144 weeks
Total Duration
On this page
Sponsors
M
MedSIR
Lead Sponsor
M
Medical University of Vienna
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must understand the study purpose and sign informed consent
- Female or male patients at least 18 years old
- Ability to swallow capsules intact
- Histologically confirmed non-small cell lung cancer
- Presence of active brain metastases with or without symptoms
- No immediate need for brain surgery or radiotherapy
- Type II leptomeningeal disease allowed
- Confirmed ROS1 gene rearrangement by certified laboratory
- Measurable brain lesion at least 10 mm on MRI
- ECOG performance status of 2 or less
- Life expectancy of at least 6 weeks
- Any number of prior chemotherapies, immunotherapy or non-ROS1 TKI treatments allowed
- No prior ROS1 TKI treatments
- Left ventricular ejection fraction 50% or higher
- Archival tumor biopsy sample at baseline if possible
- Adequate bone marrow, liver, and kidney function
- Recovery from prior cancer therapy side effects to grade 1 or less (except alopecia)
- Women of childbearing potential must have negative pregnancy test and use effective contraception
- Male participants must be sterile or use contraception and not donate sperm
- Accessible for treatment and follow-up
You will not qualify if you...
- Major surgery within 4 weeks before treatment start
- Type I leptomeningeal disease
- Radiotherapy within 2 weeks before first dose (4 weeks for brain radiation)
- Cancer treatment within 14 days before study treatment
- Abnormal heart rhythms or conditions increasing risk of QT prolongation
- Significant cardiovascular disease within 6 months
- Active infections not controlled by treatment
- Gastrointestinal diseases affecting drug absorption
- Peripheral neuropathy grade 2 or higher
- Severe interstitial lung disease or fibrosis
- Other severe medical or psychiatric conditions increasing risk or interfering with study
- Other primary cancers within 5 years except treated skin or in situ carcinomas
- Use of strong CYP3A inhibitors or inducers
- Use of high-dose systemic corticosteroids except for adverse event management
- Allergy to study drug or ingredients
- Recent exposure to investigational drugs
- Contraindications to MRI including claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Medizinische Universität Graz
Graz, Austria, 8010
Actively Recruiting
2
Medical University of Vienna
Vienna, Austria
Actively Recruiting
3
Ludwig-Maximilians-University Munich
München, Germany
Actively Recruiting
4
Hospital de Vinalopó
Elche, Alicante, Spain, 03293
Actively Recruiting
5
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain, 43204
Actively Recruiting
6
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Actively Recruiting
7
Hospital de Cruces
Barakaldo, Spain, 48903
Actively Recruiting
8
UOMI Cancer Center
Barcelona, Spain, 08017
Actively Recruiting
9
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
10
Institut Català d' Oncologia Girona (ICO)
Girona, Spain, 17007
Actively Recruiting
11
Hospital Universitario de León
León, Spain, 24008
Actively Recruiting
12
Hospital Lucus Agusti
Lugo, Spain, 27003
Actively Recruiting
13
Hospital Beata María Ana
Madrid, Spain, 28007
Actively Recruiting
14
Hospital Universitario Vithas Madrid La Milagrosa
Madrid, Spain, 28010
Actively Recruiting
15
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, Spain, 15706
Actively Recruiting
16
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
M
MEDSIR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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