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

Sponsor
MedSIR
Study ID
NCT06315010
Phase
PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases
  • NSCLC
  • ROS1 Gene Rearrangement

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Repotrectinib — DRUG
    Repotrectinib is administered orally in capsule form, with each capsule containing size 0 hard gelatin 40 mg of the active compound in bottles containing 30 capsules. Repotrectinib is administered orally in the form of capsules. The capsules are taken by mouth and swallowed intact (without chewing, crushing, or opening) with water or another suitable liquid.

Study Details

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.

Key Dates

Start date
Jun 27, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Repotrectinib
    Repotrectinib 160 mg orally (PO) every day (QD) for 14 days, and 160 mg twice a day (BID) thereafter.

Primary Outcome Measure

Intracranial Objective Response Rate (IC-ORR) [ Time Frame: 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. ]

Central Contacts

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