Aumolertinib with or Without Chemotherapy As 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing EGFR Mutations

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

624

Participants

Timeline

Start Date

August 11, 2021

Primary Completion Date

June 18, 2024

Study Completion Date

January 31, 2026

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

Aumolertinib

"Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4\~6 cycles, followed by Aumolertinib 100mg QD with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles.~Dose may be reduced to allow for the management of investigational drug related toxicity."

DRUG

Placebo Aumolertinib

Placebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity.

Trial Locations (1)

Unknown

Shanghai Chest Hospital, Shanghai

All Listed Sponsors
lead

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY