High-dose Furmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed Chemotherapy in Pati… (NCT06812871) | Clinical Trial Compass
CompletedPhase 2
High-dose Furmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Meningeal Metastasis
China46 participantsStarted 2024-01-01
Plain-language summary
the study conducted to evaluate the efficacy and safety of high-dose furmonertinib (160 mg qd) combined with bevacizumab and pemetrexed intrathecal chemotherapy in NSCLC patients with EGFR mutations and meningeal metastases.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Histological or cytological localization is NSCLC;
* confirmed EGFR exon 19 deletion mutation(19del) or EGFR exon 21L858R mutation (L858R) or EGFR exon 20 T790M mutation (T790M)）;
* Clinical diagnosis of meningeal aggravation: clinical symptoms of intracranial hypertension (headache, dizziness, vomiting, etc.) + imaging confirmation (cerebral MRI diagnosis of meningeal aggravation) or cerebrospinal fluid cytology confirmation;
* for patients with symptoms who are considered to need temporary brain local. Treatment of cough receiving adrenal corticosteroids must be kept stable or reponse for at least 1 week before the first trial of the drug preparation;
* Newly diagnosed meningeal metastasis, including meningeal metastasis after previous brain surgery and/or local radiotherapy for solid metastatic disease;
* Patients did not received systemic treatment after diagnosed meningeal metastases.
* Obtain informed consent signed by the patient's legal representative;
* Aged ≥18 years and ≤75 years;
* Eastern Tourism Cooperation Group (ECOG) Physical condition evaluation 0-1;
* Life expectancy ≥12 week;
* Able to follow the requirements of the study protocol and confirmation procedures, and able to accept cranial wall medications;
* contraception.
Exclusion Criteria:
* Mixed non-small cell and small cell carcinoma, or squamous cell carcinoma as the main pathological type;
* history of hypersensitivity reaction to active or inactive excipients of furmonertinib…
What they're measuring
1
Intracranial progression-free survival
Timeframe: The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first, assessed up to 24 months