A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)
- Conditions
- Small Cell Lung CarcinomaCarcinoma, Non-Small Cell LungTriple Negative Breast CarcinomaHepatocellular CarcinomaUrothelial Carcinoma
- Interventions
- Registration Number
- NCT03232593
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the MFDS in Korea.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1758
- Participants who are administered with atezolizumab for the locally approved indications
- Participants with a known hypersensitivity to atezolizumab or to any of the excipients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants who Receive Atezolizumab Atezolizumab Participants who are administered with atezolizumab as per the local label and standard of care at physician's discretion will be observed for approximately 6 years.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Approximately 6 years
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1 Approximately 6 years Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Approximately 6 years Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1 Approximately 6 years Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1 Approximately 6 years
Trial Locations
- Locations (55)
Dongnam Inst.of Radiological & Medical Sciences
🇰🇷Busan, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Inje university Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Donga Uni Medical Center; Pulmonary
🇰🇷Busan, Korea, Republic of
Pusan University Hospital
🇰🇷Busan, Korea, Republic of
Pusan University Hospital; Hemato-oncology
🇰🇷Busan, Korea, Republic of
Kyungpook National University Medical Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangwon-do, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Keimyung University Dongsan Hospital; Pulmonology
🇰🇷Daegu, Korea, Republic of
Hallym University Medical Center Chuncheon Sacred Heart Hospital
🇰🇷Gangwon-do, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wonju-Si, Korea, Republic of
Uijeongbu St. Mary's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Bucheon St Mary's hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
St. Vincent's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeollabuk-do, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital
🇰🇷Hwaseong Si, Korea, Republic of
Wonkwang University School of Medicine & Hospital
🇰🇷Jeonlabuk-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Eunpyeong St. Mary's Hoapital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Hospital
🇰🇷Seoul, Korea, Republic of
Gangdong Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
VHS Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Borame Medical Center
🇰🇷Seoul, Korea, Republic of
ChungAng University Hospital
🇰🇷Seoul, Korea, Republic of
Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System; Oncology
🇰🇷Seoul, Korea, Republic of
Samsung Medical Centre; Division of Hematology/Oncology
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital; Urology
🇰🇷Seoul, Korea, Republic of
Korea Uni Anam Hospital; Internal Medicine
🇰🇷Seoul, Korea, Republic of
Ulsan University Hosiptal
🇰🇷Ulsan, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Pusan National University Yangsan Hospital; hemato-oncology
🇰🇷Yangsan, Korea, Republic of
SoonChunHyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of