Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06970639 | A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases | PHASE3 | RECRUITING | 380 | — | — | Sep 26, 2024 | Sep 1, 2029 | Feb 12, 2026 | 1 | China |
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Randomized Controlled Phase：PFS assessed by BICR based on recist1.1; PFS was defined as the time from the date of randomization to the date of first documented disease progression (assessed according to RECIST v1.1 criteria) or death from any cause, whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| Furmonertinib combined with chemotherapy | EXPERIMENTAL | Furmonertinib Mesilate Tablets+Carboplatin Injection/Cisplatin for injection+Pemetrexed Disodium for Injection |
| Osimertinib Mesylate Tablets | ACTIVE_COMPARATOR | Osimertinib Mesylate Tablets |
| Name | Type | Description |
|---|---|---|
| Furmonertinib Mesilate Tablets | DRUG | Usage and dosage: 80mg, 240mg, or 160mg QD orally Medication duration: A cycle of 21 days until intolerable toxicity, disease progression, death, or initiation of new anti-tumor therapy occurs |
| Carboplatin Injection | DRUG | Usage and dosage: Administer via IV infusion, with a dosage of AUC5, not exceeding 750 mg. Medication schedule: every 3 weeks as a cycle, D1 administration per cycle, immediate administration of carboplatin upon completion of pemetrexed infusion, intravenous infusion, carboplatin can be used for up to 4 cycles. |
| Cisplatin for injection | DRUG | Usage and dosage: Administer via IV infusion at a dose of 75 mg/m2. Medication schedule: Every 3 weeks as a cycle, with D1 administration per cycle. Cisplatin is administered approximately 30 minutes after the infusion of pemetrexed, via intravenous infusion. Adequate hydration therapy must be received before and after cisplatin treatment. Cisplatin can be used for up to 4 cycles. |
| Pemetrexed Disodium for Injection | DRUG | Usage and dosage: Intravenous (IV) infusion administration, dosage of 500 mg/m2 Medication schedule: Administer on the first day of each cycle (21 days per cycle, i.e. every 3 weeks) until intolerable toxicity, disease progression, death, or initiation of new anti-tumor therapy occurs. |
| Osimertinib Mesylate Tablets | DRUG | Usage and dosage: 80mg, QD administration Medication duration: A cycle of 21 days until intolerable toxicity, disease progression, death, or initiation of new anti-tumor therapy occurs |
Inclusion Criteria: 1. Fully understand the trial and voluntarily sign the informed consent form; 2. Age ≥18 years at the time of signing ICF, regardless of gender; 3. Histologically/cytologically confirmed non-squamous NSCLC with brain parenchymal metastases assessed by BICR; Subjects with both br...