At a glance
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NCT06431685Phase 1RecruitingUpdate OverdueCompletion was 15mo agoPhase I Study of Whole Brain Low Dose Radiotherapy Combined With ICI and Intrathecal Chemotherapy for Treatment of Refractory Meningeal Metastasis of Lung Cancer
In Brief
A Phase 1 clinical trial evaluating Whole Brain Low Dose Radiotherapy, Pemetrexed, and 2 other interventions for NSCLC and 3 related conditions. Currently recruiting, targeting 10 participants across 1 site.
Signals
Detailed Summary
This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.
Study Details
Timeline
Interventions
Whole brain LDRT will be administered at 3 cohorts with increasing dose fractions: Group 1: 4 Gy/2f of one cycle; Group 2: 4 Gy/2f of two cycles (Q3w); Group 3: 4 Gy/2f of three cycles (Q3w). WB-LDRT will be administered in a 4 Gy of 2 fractions over two days, starting from Day 1 in the first cycle (a daily dose of 2 Gy, 4 Gy/2f for one cycle, once per three weeks, at minmum in one cycle and maximum in four cycles in total).
Pemetrexed, 30 mg, intrathecal injection, once per three weeks, 4 cycles in total
PD-1 inhibitor (Sintilimab, dose as recommended in the instruction manual), intravenous infusion, once per three weeks, 4 cycles in total
Pemetrexed at a dose of 500 mg/m\^2, intravenous infusion, once per three weeks, 4 cycles in total