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OncoMatch/Clinical Trials/NCT06901817

A Study of the Safety and Efficacy of Pemetrexed Combined with Nivolumab Via Intraventricular Injection for the Treatment of Refractory Non-squamous Non-small Cell Lung Cancer with Leptomeningeal Metastases

Is NCT06901817 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Intraventricular Pemetrexed and Intraventricular Nivolumab for leptomeningeal metastasis.

Phase 2RecruitingShanghai Cancer Hospital, ChinaNCT06901817Data as of May 2026

Treatment: Intraventricular Pemetrexed · Intraventricular Nivolumab · Intraventricular DexamethasoneThe goal of this clinical trial is to learn if the intraventricular injection of Pemetrexed and Nivolumab works to treat refractory non-squamous non-small cell lung cancer with leptomeningeal metastases. The main questions to answer are: * Is the combination of Pemetrexed and Nivolumab safe to inject? * How effective is the combination in disease control? Participants will: * Intrathecal injection of 30 mg pemetrexed via Ommaya reservoir, once every 4 weeks until disease progression; * Intrathecal injection of 40 mg nivolumab via Ommaya reservoir, once every 4 weeks until disease progression; * Before each intrathecal administration, a preliminary intrathecal injection of dexamethasone, 5 mg/2 mL, is given.

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Extracted eligibility criteria

Biomarker criteria

Required: EGFR T790M

Failed first- or second-generation TKI treatment, T790M mutation-negative

Required: EGFR mutation-negative

EGFR gene mutation-negative, failed first-line treatment

Disease stage

Metastatic disease required

Performance status

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

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

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