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

PHASE3RecruitingINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

September 26, 2024

Primary Completion Date

March 31, 2029

Study Completion Date

September 30, 2029

Conditions
NSCLC Patients With Brain Metastasis
Interventions
DRUG

Furmonertinib Mesilate Tablets

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

DRUG

Carboplatin Injection

"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."

DRUG

Cisplatin for injection

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.

DRUG

Pemetrexed Disodium for Injection

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.

DRUG

Osimertinib Mesylate Tablets

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

Trial Locations (1)

Unknown

RECRUITING

Guangdong Provincial People's Hospital, Guangdong

Sponsors
All Listed Sponsors
lead

Allist Pharmaceuticals, Inc.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter