OncoMatch/Clinical Trials/NCT06552234
Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC
Is NCT06552234 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Repotrectinib for nsclc stage iv.
Treatment: Repotrectinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ROS1 rearrangement
Disease stage
Required: Stage III, IV
Prior therapy
Cannot have received: ROS1 inhibitor
Exception: TKI-naïve cohort only
No prior ROS1 TKI is allowed for the TKI naïve cohort.
Lab requirements
Blood counts
ANC ≥ 1500 /mm3 without G-CSF; lymphocyte count ≥ 500/mm3; platelet count ≥ 100,000/mm3 without transfusion; hemoglobin ≥ 9.0 g/dL (transfusion allowed); INR or aPTT ≤ 1.5x ULN (unless on stable therapeutic anticoagulation)
Kidney function
Calculated creatinine clearance (CRCL) ≥ 45 mL/min
Liver function
ASAT, ALAT, and alkaline phosphatase ≤ 2.5xULN (≤ 5xULN for liver mets); serum bilirubin ≤1.25xULN (≤ 3xULN for Gilbert disease); alkaline phosphatase < 5xULN for liver or bone mets
Adequate hematologic and end-organ function, defined by the following laboratory ... (see above for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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