A Single-Arm Clinical Study of Ivonescimab Combined with Targeted Therapy and Intrathecal Therapy for Leptomeningeal Metastasis in EGFR/ALK-Positive Non-Small Cell Lung Cancer?

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500109516

Enrollment

Unknown

Registered

2025-09-19

Start date

2025-10-01

Completion date

Unknown

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leptomeningeal Metastasis in EGFR/ALK-Positive Non-Small Cell Lung Cancer?

Interventions

Treatment group:Ivonescimab Combined with Targeted Therapy and Intrathecal Therapy

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ??(1) Age >= 18 years with ECOG performance status 0–2.?? ??(2) Histologically or cytologically confirmed NSCLC?? demonstrating EGFR or ALK positivity through: Next-generation sequencing (NGS) testing of tissue/cytology specimens Reports from accredited molecular laboratories Mutation specifics: EGFR: Sensitizing variants (Ex19del, L858R, G719X, S768I, L861Q), T790M, or C797S (eligible post 3rd-gen TKI progression) ALK: Known rearrangements (EML4-ALK, KIF5B-ALK, TPM3-ALK, TFG-ALK, HIP1-ALK, etc.) (3) ??Leptomeningeal metastasis (LM) diagnosis?? confirmed by: Contrast-enhanced MRI and/or Cerebrospinal fluid cytology (Per EANO-ESMO guidelines) ??(4) Disease progression?? following prior systemic therapy (intra/extra-cranial). (5) ??Functional status??: Karnofsky score (KPS) >= 60 with life expectancy >= 3 months. ??(6) Clinical suitability?? for ivonescimab + intrathecal chemotherapy without contraindications. ??(7) Signed informed consent?? for protocol-specific participation.

Exclusion criteria

Exclusion criteria: ??(1) EGFR Exon20 insertion mutations?? (ineligible due to intrinsic TKI resistance). ??(2) Concurrent/prior malignancies?? (active or within 5 years). ??(3) Significant CNS complications??:Progressive cerebral edema, Refractory seizures, Uncontrolled neurologic deterioration ??(4) Whole brain radiotherapy = 3 toxicity from prior??:Immunotherapy, Anti-VEGF agents (7) ??Clinically significant systemic comorbidities??: Active autoimmune disorders, CNS infections, Uncontrolled infections (TB, HBV*, HIV), Hepatic impairment (ALT/AST >3×ULN), Renal dysfunction (CrCl = 160/100 mmHg), Bleeding diathesis/thrombocytopenia?, Anticoagulant therapy with bleeding risk (INR>2.0, PT>16s) ??(8) Pregnancy/lactation or ineffective contraception??*. ??(9) Cognitive impairment?? precluding protocol compliance. ??(10) Investigator-judged risks?? affecting trial conduct/safety.

Design outcomes

Primary

Measure	Time frame
CSF Tumor Markers;Progression Free Survival, PFS;	—

Secondary

Measure	Time frame
Overall survival, OS;Objective response rate, ORR;Duration of remission, DOR;	—

Countries

China

Contacts

Public ContactYin Zhenyu

Nanjing Drum Tower Hospital

zhenyuyin68@163.com+86 139 1390 4579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026