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

Status: Terminated
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patient is at least 18 years of age (or country's legal age of majority if the legal age was > 18 years) at the time of obtaining informed consent.

• Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements

• Patient has histologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to treatment with curative intent

• Patient has had at least one prior systemic treatment for NSCLC, but no more than three prior systemic therapy

• Patient has adequate tumor tissue obtained from a biopsy or surgical procedure to enable molecular profiling for central laboratory confirmation of the mutation.

• Patient is positive for EGFR or HER2 exon 20 mutations based on tissue testing:

• Cohort 1: Documented EGFR exon 20 insertion mutation (including duplication mutations)

• Cohort 2: Documented HER2 exon 20 insertion mutation (including duplication mutations)

• Patient has measurable disease, as per the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). Metastatic lesions in CNS or in brain cannot be used for target lesions.

• Brain metastases may be allowed if patient's condition is stable.

• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and has a life-expectancy of more than 6 months

• Patient has recovered from prior systemic therapy for metastatic disease to Grade ≤1 for non-hematologic toxicities (except for Grade ≤2 peripheral neuropathy) and has adequate hematologic, hepatic, and renal function at Baseline

• Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of poziotinib

• Females of childbearing potential must have a negative pregnancy test within 30 days prior to enrollment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or who are surgically sterilized do not require this test.

Locations
Other Locations
China
Beijing Cancer Hospital
Beijing
Beijing Chest Hospital
Beijing
Beijing Hospital
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Peking Union Medical College Hospital
Beijing
Jilin Cancer Hospital
Changchun
The First Hospital of Jilin University
Changchun
The Third Xiangya Hospital of Central South University
Changsha
Sichuan Cancer Hospital and Institute
Chengdu
West China Hospital of Sichuan University
Chengdu
Fujian Provincial Cancer Hospital
Fuzhou
Guangdong General Hospital
Guangzhou
Guangdong Panyu Central Hospital
Guangzhou
Shi Run Run Shaw Hospital, Zhejiang University
Hangzhou
The First Affiliated Hospital, Zhejiang University
Hangzhou
Zhejiang Cancer Hospital
Hangzhou
The Second Hospital of Anhui Medical University
Hefei
Shanghai Chest Hospital
Shanghai
University of Hong Kong-Shenzhen Hospital
Shenzhen
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Republic of Korea
Chungbuk National University Hospital
Cheongju
National Cancer Center
Gyeonggi-do
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Time Frame
Start Date: July 30, 2019
Completion Date: April 13, 2020
Participants
Target number of participants: 5
Treatments
Experimental: Poziotinib
Cohort 1 : Previously treated patients with EGFR exon 20 insertion mutation positive NSCLC~Cohort 2: Previously treated patients with HER2 exon 20 insertion mutation positive NSCLC
Sponsors
Leads: Hanmi Pharmaceutical Company Limited

This content was sourced from clinicaltrials.gov

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