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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

Non-small Cell Lung Cancer Clinical Trial

Official title:
A Randomized Controlled, Open-lable, Phase III, Multicenter Clinical Study of Almonertinib Versus Platinum-based Chemotherapy as First-line Therapy in Patients With Locally Advanced or Metastatic NSCLC Harbouring Uncommon EGFR Mutation

Clinical Trial Summary

To assess the efficacy and safety of Almonertinib versus platinum-based chemotherapy as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutation.

Clinical Trial Description

This is a randomized, open-lable, multicenter, 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 non-small cell lung cancer (NSCLC) harboring at least one uncommon EGFR mutation, including L861Q, G719X or S768I. Patients who have not received any systemic treatment to receive Almonertinib or platinum-based chemotherapy in a 1:1 ratio, and treatment will be continued until disease progression, unacceptable toxicity or other discontinuation criteria are met. After progression, patients may receive Almonertinib for as long as their treating physician considers they are deriving clinical benefit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04951648
Study type Interventional
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact Li Zhang
Phone 020-87342288
Email zhangli@sysucc.org.cn
Status Not yet recruiting
Phase Phase 3
Start date July 15, 2021
Completion date September 6, 2024
View Details
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