Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC

Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study ID
NCT06552234
Phase
PHASE2
Status
Recruiting
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Conditions

  • NSCLC Stage IV
  • NSCLC, Stage III

Eligibility Criteria

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

Interventions

  • Repotrectinib — DRUG
    Repotrectinib 160 mg BID, until progression or unacceptable toxicity

Study Details

ROS1 rearrangements are rare, accounting for only 1-2% of NSCLC cases, but have been associated with response to ROS1 inhibitors, such as crizotinib and entrectinib. However, many patients develop resistance to the tyrosine-kinase inhibitors (TKIs), creating a need for new treatments. Repotrectinib is a new-generation TKI designed against ROS1 or NTRK rearranged malignancies (Drilon 2018). Early phase clinical data support activity of repotrectinib in patients with NSCLC harboring such gene rearrangements (TRIDENT-1 study), but there are limited evidence in frail populations, such as poor performance status patients and/or elderly patients, who are classically excluded from clinical trials or underrepresented. The present study aims to assess the activity and tolerability of repotrectinib in frail (PS ≥2) and/or elderly patients with ROS1-rearranged advanced NSCLC.

Key Dates

Start date
Oct 1, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2031
Completion
Sep 30, 2031

Study Design

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

Arms

  • Experimental: Repotrectinib treatment
    patient treated by Repotrectinib until progression or unacceptable toxicity

Primary Outcome Measure

Objective response rate (ORR) according to RECIST v1.1. [ Time Frame: From the date of first treatment administration until the date of disease progression or death if patient died before progression) or the introduction of a new treatment, which ever occurs earlier, assessed up to 7 years ]

Central Contacts

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