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ACTIVE NOT RECRUITING
NCT04923906
PHASE3

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

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).

Official title: Efficacy and Safety of Aumolertinib with or Without Chemotherapy As First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing Epidermal Growth Factor Receptor Mutations: a Randomized, Controlled, Open-label, Phase 3 and Multicenter Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

624

Start Date

2021-08-11

Completion Date

2026-01-31

Last Updated

2024-11-25

Healthy Volunteers

No

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Chest Hospital, China