Last reviewed · How we verify
NCT06766591
Ivonescimab Combined With Chemotherapy for the Treatment of Leptomeningeal Metastases Failed to EGFR-TKIs
NA trial testing Ivonescimab combined with chemotherapy in NSCLC in 36 participants. Not yet recruiting.
31 October 2025
Quick facts
| Lead sponsor | Jiangsu Province Nanjing Brain Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 January 2025 |
| Primary completion | 31 October 2025 |
| Estimated completion | 31 October 2025 |
Drugs / interventions tested
- Ivonescimab combined with chemotherapy — full drug profile →
Conditions studied
- NSCLC — all drugs for NSCLC →
- Chemotherapy — all drugs for Chemotherapy →
- Leptomeningeal Metastases — all drugs for Leptomeningeal Metastases →
- EGFR-TKI — all drugs for EGFR-TKI →
Sponsor
Jiangsu Province Nanjing Brain Hospital
Who can join
Adults 18 to 75, any sex, with NSCLC or Chemotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Research objective Main purpose Exploring the real-world effectiveness of Ivonescimab combined with chemotherapy for EGFR mutant NSCLC with leptomeningeal metastasis after EGFR-TKIs resistance. Outcome measure: Real world intracranial disease-free survival time (iPFS). Secondary purpose Federation patterns: describing different treatment modes in the real world; Outcome measures: Combination chemotherapy regimen and duration of chemotherapy. Efficacy: Further explore the effectiveness of Ivonescimab combined with chemotherapy for EGFR mutant NSCLC with leptomeningeal metastasis failed with EGFR-TKI treatment; Outcome measures: Objective response rate (LM-ORR), duration of intracranial response (iDoR), overall progression free survival (PFS), overall survival (OS), improvement in neurological function, CSF response rate based on CSF cytology. Safety: Explore the safety of Ivonescimab combined with chemotherapy for NSCLC patients with leptomeningeal metastases who have failed EGFR-TKI treatment; Outcome measures: incidence of adverse events (TEAEs), laboratory test outliers, and serious adverse events (SAEs). Research endpoint Primary endpoint * iPFS (intracranial progression free survival). Secondary endpoint * Efficacy: leptomeningeal ORR (LM-ORR), intracranial duration of response (iDoR), overall progression free survival (PFS), overall survival (OS), improvement in neurological function, and CSF response rate based on CSF cytology; * Safety: Determine the incidence and severity of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE5.0 standards; Changes in vital signs, laboratory abnormalities, and quality of life scores. Exploratory endpoint: efficacy related biomarkers
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Directions of Immunotherapy for Non-Small-Cell Lung Cancer Treatment: Past, Present and Possible Future.
Leone GM, Scuderi G, Fagone P, Mangano K. · · 2025 · PMID 41303538 · DOI 10.3390/ijms262211055
Verify or expand the search:
- PubMed search for NCT06766591
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jiangsu Province Nanjing Brain Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06766591 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu Province Nanjing Brain Hospital
- Last refreshed: 9 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06766591.
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