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OncoMatch/Clinical Trials/NCT06315010

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

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

Phase 2RecruitingMedSIRNCT06315010Data as of May 2026

Treatment: RepotrectinibREPOSE 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

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ROS1 rearrangement

Performance status

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

Prior therapy

Cannot have received: ros1 tyrosine kinase inhibitor

Lab requirements

Blood counts

WBC > 3.0 x 10^9/L, ANC ≥ 1.5 x 10^9/L, platelets ≥ 100.0 x 10^9/L, hemoglobin ≥ 8.0 g/dL (≥ 4.96 mmol/L); no transfusion or G-CSF support within 28 days

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

Cardiac function

LVEF ≥ 50% by ECHO or MUGA; mean resting QTc ≤ 470 msec; no clinically important ECG abnormalities; no factors increasing risk of QTc prolongation or arrhythmia; no significant cardiovascular disease (see exclusion 6)

Patient has adequate bone marrow, liver, and renal function: ... LVEF ≥ 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan. ... See exclusion criteria for cardiac details.

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

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