Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 25, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

December 31, 2026

Conditions
NSCLCLow Dose RadiotherapyPD-1 InhibitorLeptomeningeal Metastasis
Interventions
RADIATION

Whole Brain Low Dose Radiotherapy

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).

DRUG

Pemetrexed

Pemetrexed, 30 mg, intrathecal injection, once per three weeks, 4 cycles in total

DRUG

Sintilimab

PD-1 inhibitor (Sintilimab, dose as recommended in the instruction manual), intravenous infusion, once per three weeks, 4 cycles in total

DRUG

Chemotherapy

Pemetrexed at a dose of 500 mg/m\^2, intravenous infusion, once per three weeks, 4 cycles in total

Trial Locations (1)

610041

RECRUITING

West China Hospital, Sichuan University, Chengdu

All Listed Sponsors
lead

Sichuan University

OTHER