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 (Jun 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
Treatments studied
Targeted therapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
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)
Demographics
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.
Frequently asked questions
Is NCT07304739 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR L858R is a required biomarker for enrollment.
Are patients with ALK alterations eligible?
No. ALK driver gene is an exclusion criterion.
Are patients with ROS1 alterations eligible?
No. ROS1 driver gene is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages