A Phase III Study to Assess the Efficacy and Safety of Almonertinib Versus Platinum-based Chemotherapy as First-line Therapy in Patients With Locally Advanced or Metastatic NSCLC Harbouring Uncommon EGFR Mutation

PHASE3UnknownINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

July 15, 2021

Primary Completion Date

October 4, 2023

Study Completion Date

September 6, 2024

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

Almonertinib

Almonertinib 165 mg,orally once a day Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met.

DRUG

chemotherapy

Pemetrexed (500mg/m2) plus Carboplatin (AUC5)or Pemetrexed (500mg/m2) plus Cisplatin (75mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4\~6 cycles, followed by pemetrexed mainten-ance therapy every 3 weeks until disease progress-ssion, unacceptable toxicity or other discontinuation criteria are met.

Trial Locations (1)

Unknown

Sun yat-sen Univerisity Cancer Center, Guangzhou

All Listed Sponsors
lead

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY