Spots Global Cancer Trial Database for Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Official Title: A Phase 2 Study of Poziotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Exon 20 Mutation in China and Korea
Study ID: NCT04044170
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in two patient cohorts for up to 114 previously treated NSCLC patients with any systemic therapy (57 patients with EGFR exon 20 insertion mutations and 57 patients with HER2 exon 20 insertion mutations).
Detailed Description: The Screening period (Day -30 to Day -1) lasts up to approximately 30 days prior to Cycle 1, Day 1. Patients must meet all Inclusion/Exclusion Criteria to participate in the study. Eligible patients will provide written Informed Consent prior to any study procedures. Each treatment cycle is 28 calendar days in duration. There will be two patient cohorts and eligible patients will be enrolled into each cohort in parallel based on EGFR or HER2 exon 20 mutation status: * Cohort 1 : Previously treated patients with EGFR exon 20 insertion mutation positive NSCLC (N=57) * Cohort 2 : Previously treated patients with HER2 exon 20 insertion mutation positive NSCLC (N=57) Toxicity will be assessed based on the severity grade of the adverse events using CTCAE version 4.03. Poziotinib (16 mg) will be taken orally, once daily (QD) with food and a glass of water at approximately the same time each morning. All patients will be treated until disease progression, death, intolerable adverse events (AEs), or other protocol-specified reasons for patient withdrawal.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, , China
Beijing Chest Hospital, Beijing, , China
Beijing Hospital, Beijing, , China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Jilin Cancer Hospital, Changchun, , China
The First Hospital of Jilin University, Changchun, , China
The Third Xiangya Hospital of Central South University, Changsha, , China
Sichuan Cancer Hospital and Institute, Chengdu, , China
West China Hospital of Sichuan University, Chengdu, , China
Fujian Provincial Cancer Hospital, Fuzhou, , China
Guangdong General Hospital, Guangzhou, , China
Guangdong Panyu Central Hospital, Guangzhou, , China
Shi Run Run Shaw Hospital, Zhejiang University, Hangzhou, , China
The First Affiliated Hospital, Zhejiang University, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
The Second Hospital of Anhui Medical University, Hefei, , China
Shanghai Chest Hospital, Shanghai, , China
University of Hong Kong-Shenzhen Hospital, Shenzhen, , China
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Chungbuk National University Hospital, Cheongju, , Korea, Republic of
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Hanmi Pharmaceuticals
Affiliation: Hanmi Pharmaceuticals
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
