OncoMatch/Clinical Trials/NCT07304739
Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR-Mutated NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases
Is NCT07304739 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Furmonertinib and Intrathecal chemotherapy for non small cell lung cancer.
Treatment: Furmonertinib · Intrathecal chemotherapy — A Single-Arm Clinical Study of Furmonertinib (160mg) Combined with Intrathecal Chemotherapy (ITC) and Stereotactic Radiotherapy (SRT) as First-Line Treatment in EGFR Classic Mutation-Positive NSCLC Patients with Brain Parenchymal and Leptomeningeal Metastases
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: EGFR exon 19 deletion
one of the following EGFR mutations :19Del or L858R
Required: EGFR L858R
one of the following EGFR mutations :19Del or L858R
Excluded: ALK driver gene
Patients with other driver genes: ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, etc.. But TP53, RB1, BRAC are not included
Excluded: ROS1 driver gene
Patients with other driver genes: ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, etc.. But TP53, RB1, BRAC are not included
Excluded: RET driver gene
Patients with other driver genes: ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, etc.. But TP53, RB1, BRAC are not included
Excluded: BRAF driver gene
Patients with other driver genes: ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, etc.. But TP53, RB1, BRAC are not included
Excluded: NTRK1 driver gene
Patients with other driver genes: ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, etc.. But TP53, RB1, BRAC are not included
Excluded: NTRK2 driver gene
Patients with other driver genes: ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, etc.. But TP53, RB1, BRAC are not included
Excluded: NTRK3 driver gene
Patients with other driver genes: ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, etc.. But TP53, RB1, BRAC are not included
Excluded: MET driver gene
Patients with other driver genes: ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, etc.. But TP53, RB1, BRAC are not included
Excluded: KRAS driver gene
Patients with other driver genes: ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, etc.. But TP53, RB1, BRAC are not included
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anti-tumor treatment
The patient has not received any systemic anti-tumor treatment in the locally advanced (the researcher judged that it was not suitable for surgery or radiotherapy) or metastatic NSCLC
Cannot have received: antitumor drugs
Treatment with other antitumor drugs within 14 days prior to the first dose
Cannot have received: strong CYP3A4 inhibitors
Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days prior to the first dose
Cannot have received: Chinese herbal medicines or preparations with anti-tumor indications or those adjunctive to cancer therapy
Use of Chinese herbal medicines or preparations with anti-tumor indications or those adjunctive to cancer therapy within 2 weeks prior to the first dose or expected during the trial period
Cannot have received: investigational drug or device
Participation in an investigational drug or device clinical trial within 4 weeks or at least 5 half-lives (whichever is longer) prior to the first dose
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; PLT ≥100×10^9/L; HGB ≥90g/L
Kidney function
CrCL ≥50 ml/min (Cockcroft-Gault)
Liver function
TBIL ≤1.5x ULN, AST and ALT ≤2.5x ULN (≤3x ULN TBIL and ≤5x ULN AST/ALT if liver metastasis)
Cardiac function
QTc ≤ 470 msec; no clinically significant prolonged QT interval or arrhythmias
Laboratory tests indicated that the subjects had adequate organ functions, including: 1) ANC ≥1.5×109/L; PLT ≥100×109/L; HGB ≥90g/L; 2) TBIL ≤1.5 times the upper limit of the normal value, AST and ALT ≤2.5 times the upper limit of the normal value (for those with liver metastasis, total bilirubin ≤ 3 times the upper limit of the normal value, AST and ALT≤ 5 times the upper limit of the normal value are allowed); 3) CrCL ≥50 ml/min (calculated according to the Cockcroft-Gault formula); Resting QT interval (QTc) > 470 msec as measured by clinical ECG screening; Clinically significant prolonged QT interval or other arrhythmias or clinical conditions that may increase the risk of QT prolongation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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