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NCT07092202
Firmonertinib Combined With Intrathecal Injection for the Treatment of EGFR Mutant NSCLC With Leptomeningeal Metastases
Phase 4 trial testing Firmonertinib in Leptomeningeal Metastasis in 40 participants. Currently enrolling.
1 May 2027
Quick facts
| Lead sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 15 April 2025 |
| Primary completion | 1 May 2027 |
| Estimated completion | 1 November 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Firmonertinib — full drug profile →
- Intrathecal injection of pemetrexed — full drug profile →
Conditions studied
- Leptomeningeal Metastasis — all drugs for Leptomeningeal Metastasis →
- NSCLC — all drugs for NSCLC →
- Intrathecal Chemotherapy — all drugs for Intrathecal Chemotherapy →
- Tyrosine Kinase Inhibitor — all drugs for Tyrosine Kinase Inhibitor →
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Who can join
18 and older, any sex, with Leptomeningeal Metastasis or NSCLC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Leptomeningeal metastases (LM) are a relatively rare site of metastasis in advanced non-small cell lung cancer (NSCLC), and LM patients have a poor prognosis. Numerous retrospective studies have reported that high-dose Firmonertinib can also effectively increase patient prognosis and have tolerable side effects, but there is a lack of prospective studies to confirm this. In addition, there are currently no good biomarkers for monitoring the efficacy of LM treatment. cfDNA testing can be used for early cancer screening, monitoring tumor progression, evaluating treatment response, and discovering drug resistance mechanisms. Due to the influence of the blood-brain barrier, the level of cfDNA in the plasma of LM patients is often very low, and the detection of cfDNA in cerebrospinal fluid (CSF) is more advantageous. Therefore, exploring the dynamic monitoring of LM treatment efficacy using CSF cfDNA is of great significance for improving patient prognosis. Based on this, the applicant intends to conduct a prospective, multicenter, single-arm, post-market exploratory clinical trial on the treatment methods and efficacy monitoring of NSCLC-LM patients. The aim was to explore whether cfDNA has the potential to become a biomarker for LM efficacy monitoring and to validate the efficacy and safety of high-dose fumatinib combined with intrathecal injection in the treatment of NSCLC-LM patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07092202
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Firmonertinib
Trials testing the same drug.
- NCT07314216 — Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary Adenocarcin · Phase 2 · not yet recruiting
- NCT07010419 — A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With St · Phase 3 · recruiting
- NCT07239102 — Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis · completed
Other recruiting trials for Leptomeningeal Metastasis
Currently open trials in the same condition.
- NCT07348965 — Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis · NA · recruiting
- NCT07398599 — Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metast · NA · recruiting
- NCT06296745 — Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib. · Phase 2 · recruiting
- NCT07098806 — Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases · Phase 1 · recruiting
- NCT06984523 — Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomening · NA · active not recruiting
Other Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials
Trials by the same sponsor.
- NCT07521124 — ABC Maintenance Therapy for AML · NA · not yet recruiting
- NCT07497243 — X-ray Assisted Diagnostic System · not yet recruiting
- NCT07520123 — Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatiti · NA · not yet recruiting
- NCT06970262 — FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients · NA · recruiting
- NCT07509424 — Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Lo · Phase 2 · not yet recruiting
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 NCT07092202 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Last refreshed: 29 July 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/NCT07092202.
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