NCT07182682 - A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery | Biotech Hunter

Enrollment

360

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

September 30, 2029

Study Completion Date

January 31, 2031

Conditions

Non-Small Cell Lung Cancer

Interventions

DRUG

sunvozertinib

Participants will receive oral administration of sunvozertinib 200 mg QD following randomization, with each treatment cycle defined as 21 days, until meeting any treatment discontinuation criteria (i.e, objective disease recurrence, intolerable adverse event \[AE\], completion of 3-year \[156-week\] treatment period, study termination, death, treatment or study withdrawal by participants, whichever occurs first).

DRUG

Matching Placebo

Participants will receive oral administration of placebo 200 mg QD following randomization, with each treatment cycle defined as 21 days, until meeting any treatment discontinuation criteria (i.e, objective disease recurrence, intolerable adverse event \[AE\], completion of 3-year \[156-week\] treatment period, study termination, death, treatment or study withdrawal by participants, whichever occurs first).

Trial Locations (43)

Unknown

Beijing Chest Hospital, Capital medical university, Beijing

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

China-Japan Friendship hospital, Beijing

Peking Union Medical College Hospital, Beijing

The First Hospital of Jilin University, Changchun

Hunan Cancer Hospital, Changsha

The Third Xiangya Hospital of Central South University, Changsha

Xiangya Hospital of Central South University, Changsha

Sichuan Cancer Hospital, Chengdu

West China Hospital Sichuan University, Chengdu

Fujian Cancer Hospital, Fuzhou

Fujian Medical University Union Hospital, Fuzhou

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

Zhejiang Cancer Hospital, Hangzhou

Harbin Medical University Cancer Hospital, Harbin

Anhui Provincial Cancer Hospital, Hefei

Jinan Central Hospital, Jinan

Shandong Cancer Hospital, Jinan

Yunnan Cancer Hospital, Kunming

Jiangxi Provincial People 's Hospital, Nanchang

Jiangsu Province Hospital, Nanjing

Nanjing Chest Hospital, Nanjing

Guangxi Medical University Cancer Hospital, Nanning

Fudan University Shanghai Cancer Center, Shanghai

Shanghai Chest Hospital, Shanghai

Shanghai East Hospital, Shanghai

Shanghai Pulmonary Hospital, Shanghai

Zhongshan Hospital Fudan University, Shanghai

Liaoning Cancer Hospital & Institute, Shenyang

The First Hospital of China Medical University, Shenyang

Shanxi Cancer hospital (Shanxi Cancer institute), Taiyuan

Shanxi Provincial people's hospital, Taiyuan

Taizhou Hospital, Zhejiang Province, Taizhou

Tianjin Chest Hospital, Tianjin

Tianjin Medical University Cancer Institute & Hospital, Tianjin

Tianjin Medical University General Hospital, Tianjin

Hubei Cancer Hospital, Wuhan

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

Henan Cancer Hospital, Zhengzhou

The first affiliated hospital of Zhengzhou University, Zhengzhou