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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
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
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.
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.
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.
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
Guangdong Provincial People's Hospital
Guangdong, Guangzhou, China
RECRUITINGAdverse Events (AE)
Safe import period
Time frame: Up to 4 years
Serious Adverse Event (SAE)
Safe import period
Time frame: Up to 4 years
Progression-free survival (PFS)
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.
Time frame: Up to 4 years
Progression free survival (PFS) evaluated by researchers based on RECIST 1.1
Both the safe introduction period and randomized controlled trials require evaluation of progression free survival (PFS)
Time frame: Up to 4 years
Objective response rate (ORR)
Both the safe introduction period and randomized controlled trials require evaluation of objective response rate (ORR)
Time frame: Up to 4 years
Disease control rate (DCR)
Both the safe introduction period and randomized controlled trials require evaluation of disease control rate (DCR)
Time frame: Up to 4 years
Duration of Relief (DOR)
Both the safe introduction period and randomized controlled trials require evaluation of Duration of Relief (DOR)
Time frame: Up to 4 years
Overall survival (OS)
safe introduction period
Time frame: Up to 4 years
InterPlanetary File System(iPFS) by researchers and BICR based on RECIST 1.1 evaluation
Randomized Controlled Phase
Time frame: Up to 4 years
Depth of Response(DepOR) by researchers and BICR based on RECIST 1.1 evaluation
Randomized Controlled Phase
Time frame: Up to 4 years
adverse events (AE)
Randomized Controlled Phase
Time frame: Up to 4 years
serious adverse events (SAE)
Randomized Controlled Phase
Time frame: Up to 4 years
Patient Reported Outcomes by EORTC QLQ LC13 questionnaire
Randomized Controlled Phase:To assess the impact of firmonertinib on patients' disease-related symptoms and health related quality of life (HRQoL).
Time frame: Up to 4 years
Patient Reported Outcomes by EORTCQLQ-C30 questionnaire
Randomized Controlled Phase:To assess the impact of firmonertinib on patients' disease-related symptoms and health related quality of life (HRQoL).
Time frame: Up to 4 years
Peak Plasma Concentration (Cmax)
Randomized Controlled Phase
Time frame: Up to 4 years
Steady-state oral clearance(CLss/F)
Randomized Controlled Phase
Time frame: Up to 4 years
Steady-state minimal concentration(Cmin,ss)
Randomized Controlled Phase
Time frame: Up to 4 years
Steady-state area under the curve(AUCss)
Randomized Controlled Phase
Time frame: Up to 4 years
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.