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
Summary
This study is a Phase III, international, multicenter, randomized, controlled, open-label clinical trial. The primary objective is to evaluate the efficacy and safety of furmonertinib plus platinum-based doublet chemotherapy (Arm A) versus osimertinib monotherapy (Arm B) in patients with EGFR sensitizing mutation-positive non-squamous non-small cell lung cancer (NSCLC) and brain metastases. Additionally, a proportion of subjects will receive furmonertinib monotherapy (Arm C) to further explore its efficacy and safety profile. Stage 1 is the safety run-in phase, planned to enroll approximately 30 subjects who will be randomized at a 1:1 ratio to receive either furmonertinib 80 mg QD plus platinum-based chemotherapy or furmonertinib 160 mg QD plus platinum-based chemotherapy, aiming to evaluate the safety and tolerability of different furmonertinib doses in combination with platinum-based chemotherapy. Stage 2 is the randomized controlled phase, in which approximately 350 subjects will be randomized in a 3:3:1 ratio (Arm A : Arm B : Arm C) to receive the investigational treatments.
Timeline
- Start
- 2024-09-26
- Primary completion
- 2029-03
- Completion
- 2029-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Firmonertinib | Small molecule | 80 mg | Oral |
| Subject | Firmonertinib | Small molecule | 160 mg | Oral |
| Subject | Firmonertinib | Small molecule | 240 mg | Oral |
| Comparator | Osimertinib | Small molecule | 80 mg | Oral |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
Indications
No indication recorded.