Tests low-dose brain radiation with immunotherapy and spinal chemotherapy in lung cancer
Tests low-dose brain radiation with immunotherapy in adults with lung cancer spread to brain membranes.
Key facts
- Who runs it
- Sichuan University
- Where
- Chengdu, ChinaSee the site
- Trial code
- Registry title
- Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 10 people, planned
- Started
- 25 Apr 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Whole Brain Low Dose Radiotherapy
- Pemetrexed
- Sintilimab
- Chemotherapy
- Record updated
- 8 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with lung cancer that has spread to the membranes around the brain and spinal cord, after standard treatment has failed.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Lung cancer with leptomeningeal metastasis (spread to the brain and spinal cord membranes), confirmed by spinal fluid cell tests or by clinical diagnosis. Tumors outside the brain must be stable (SD). Expected survival of at least 3 months, PS score of 3 or lower.
- Earlier treatment
- Standard treatment for lung cancer must have failed. People must agree to immunotherapy, lumbar puncture, intrathecal chemotherapy and radiotherapy.
- Biomarker or test result
- People must agree to give spinal fluid, blood and tissue samples for biomarker testing. No specific marker is required.
Main reasons for not taking part
- Active autoimmune disease or a history of autoimmune disease
- Inborn or acquired immune deficiency
- Past allogeneic organ or stem cell transplant
- Another cancer in the last 5 years
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- ≥ 18 years old and ≤ 75 years old
- Patients with a definite diagnosis of leptomeningeal metastasis by cerebrospinal fluid cytology, or patients with clinical diagnosis combined with tumor history, neuroimaging, clinical manifestations, cerebrospinal fluid examination, etc
- Patients with a clear history of lung carcinoma, including histopathological diagnosis or a combination of cytopathology and imaging, and failure of standard treatment
- Efficacy of extracranial lesions SD
- Patients with no contraindications to craniocranial radiotherapy were judged by radiotherapy doctors. Subjects who agree to receive immunotherapy, Lumbar puncture, intrathecal chemotherapy, and radiotherapy
- Expected survival ≥3 months, PS score ≤3
- Agree to provide cerebrospinal fluid, blood and tissue samples for biomarker testing
- The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases
- One week before enrollment, bone marrow and liver and kidney function met the following criteria:; ① Hemoglobin ≥80 g/L, neutrophils ≥1.5×10\^9/L and platelets ≥70×10\^9/L; ② Renal function: Cr≤ULN (upper limit of normal) × 1.5, endogenous creatinine clearance (Ccr)≥55 ml/min; Liver function: total bilirubin ≤ULN × 1.5; ALT, AST≤ULN × 2.5; (In case of liver metastasis, total bilirubin should not be higher than 3 times the upper normal limit, and transaminase should not be higher than 5 times the upper normal limit)
- The fertile women agreed to use contraception during the study period and for 6 months after the study ended; Patients who tested negative for a serum or urine pregnancy test within 7 days prior to joining the study and were not breastfed; Men who agreed to use contraception during the study period and for 6 months after the study ended
Who cannot take part
- Active autoimmune disease or history of autoimmune diseases
- Uncontrolled cardiac clinical symptoms or diseases
- Severe infection or severe comorbidities, such as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- Other systemic malignancies within the last 5 years
- Allergy to any test drug
- Uncontrolled epilepsy, neurological failure, or severe treatment-related neurological impairment, uncontrollable psychosis, and other conditions deemed unsuitable for inclusion by the investigator
- Congenital or acquired immunodeficiency
- Pregnant and lactating women, subjects with reproductive capacity are unwilling to take effective contraceptive measures
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- West China Hospital,Sichuan UniversityChengdu, ChinaContact: Lisha Xiang, MDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- whole brain LDRT + ICI + intrathecal chemotherapyTreatment being tested
The treatment regimen consisted of intrathecal chemotherapy (via lumbar puncture, pemetrexed 30 mg, once per three weeks, 4 cycles in total), PD-1 inhibitor (Sintilimab, via intravenous infusion, once per three weeks, 4 cycles in total)), pemetrexed chemotherapy (via intravenous infusion, once per three weeks, 4 cycles in total) and radiotherapy. Whole brain LDRT will be administered at 3 cohorts with increasing dose fractions: 4 Gy/2f of 2 fraction (administered a daily dose of 2 Gy for two days) in group 1; 4 Gy/2f of 4 fractions (administered a daily dose of 2 Gy for two days, once per three weeks, 2 cycles in total) in group 2; 4 Gy/2f of 8 fractions (administered a daily dose of 2 Gy for two days, once per three weeks, 4 cycles in total) in group 3.
Treatment: Whole Brain Low Dose Radiotherapy, Pemetrexed, Sintilimab, and Chemotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase I Study of Whole Brain Low Dose Radiotherapy Combined With ICI and Intrathecal Chemotherapy for Treatment of Refractory Meningeal Metastasis of Lung Cancer
- Plain-language title
- Tests low-dose brain radiation with immunotherapy and spinal chemotherapy in lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06431685, who can take part
- Record updated
- 8 May 2026