MDT-bridged Radical Therapy After Aumolertinib With MRD-guided Maintenance in EGFRm+ Unresectable Stage III NSCLC (APPROACH)

Summary

This is an open-label, multi-center, randomized, phase III study. It is aimed to firstly evaluate the effectiveness and safety of almonertinib induction therapy in EGFR-mutated patients with unresectable stage III non-small cell lung cancer, and to evaluate the effectiveness and safety of dynamic MRD guided maintenance therapy with almonertinib after induction therapy with almonertinib and local therapy (radical surgery or radiotherapy) evaluated by MDT diagnostic model. The study includes a screening period (not more than 28 days after the subject with signed informed consent before first medication), treatment period (including induction therapy with almonertinib\\ radical therapy under MDT model\\ consolidation therapy with almonertinib) and follow-up period.

Conditions

• Lung Cancer

Interventions

DRUG

Almonertinib

ctDNA dynamic monitoring guided the Almonertinib treatment group after redical surgery orradiotherapy

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.

  collaborator INDUSTRY

• Guangdong Association of Clinical Trials

  lead OTHER

Principal Investigators

• Q. Zhou · Guangdong Provincial People's Hospital

• Y. Pan · Guangdong Provincial People's Hospital

• X-N. Yang · Guangdong Provincial People's Hospital

• A-W. Liu · Second Affiliated Hospital of Nanchang University

• W-N. Feng · First People's Hospital of Foshan

• L-H. Sun · The First Affiliated Hospital of Nanchang University

• T-M. Zhang · Beijing Chest Hospital, Capital Medical University

• X-R. Dong · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

• M-F. Zhao · First Hospital of China Medical University

• H. Zhang · The Affiliated Hospital of Xuzhou Medical University

• Y. Fan · Zhejiang Cancer Hospital (Zhejiang Cancer Research Institute)

• Y. Yang · The Third People's Hospital of Chengdu

• P-L. Wang · Zhejiang University

• Q-W. Meng · The Affiliated Cancer Hospital of Harbin Medical University,

• R-R. Zhou · The Xiangya Hospital of Central South University

• Y-S. Shu · Northern Jiangsu People's Hospital

• B-H. Wang · Northern Jiangsu People's Hospital

• H-P. Xu · Fujian Cancer Hospital

• J. Li · Sichuan Cancer Hospital and Research Institute

• H. Luo · Cancer Hospital of Jiangxi Province

• Q. Bu · First Affiliated Hospital of Guangxi Medical University

• H-J. Wang · Henan Cancer Hospital

• K. Zhao · Wuhan Central Hospital

• J. Zhao · Peking University Cancer Hospital and Institute

• W-R. Yao · Jiangxi Provincial People's Hopital

• J-H. Lai · Fujian Medical University Union Hospital

• S-Y Maggie. Liu · Guangdong Provincial People's Hospital

• Q-T. Yu · Affiliated Cancer Hospital & Institute of Guangzhou Medical University

• W-H. Zhao · Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-20

Primary Completion

2026-12-31

Completion

2028-12-31

Countries

• China

Study Locations