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OncoMatch/Clinical Trials/NCT06315010

Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis

Official title: A Phase II Study Assessing Safety and Efficacy of Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis (The REPOSE Study)

Is NCT06315010 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Repotrectinib for nsclc.

Phase 2RecruitingMedSIRNCT06315010Data as of Oct 2026Location: Austria · Germany · Spain

Treatment: Repotrectinib — 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Repotrectinib

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ROS1 rearrangement

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Lab requirements

Blood counts

WBC > 3.0 x 10^9/L, ANC ≥ 1.5 x 10^9/L, platelet count ≥ 100.0 x10^9/L, hemoglobin ≥ 8.0 g/dL (≥ 4.96 mmol/L)

Kidney function

serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 40 mL/min/1.73 m2 (Cockcroft-Gault)

Liver function

Total bilirubin ≤ 1.5x ULN (≤ 3 in patients with liver metastases or Gilbert's disease); ALP ≤ 2.5x ULN; AST/ALT ≤ 3x ULN (≤ 5 in patients with liver metastases); INR < 1.5

Cardiac function

LVEF ≥ 50% by ECHO or MUGA scan

Patient has adequate bone marrow, liver, and renal function: ... see full criterion 16. LVEF ≥ 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06315010 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require ROS1?

Yes, ROS1 rearrangement is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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