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 (Jun 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
Treatments studied
Targeted therapy
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.
Frequently asked questions
Is NCT06552234 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior ROS1 inhibitor disqualifies patients from enrollment.
Does this trial require ROS1?
Yes, ROS1 rearrangement is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify