A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)

Completed

• Conditions: Small Cell Lung Carcinoma; Carcinoma, Non-Small Cell Lung; Triple Negative Breast Carcinoma; Hepatocellular Carcinoma; Urothelial Carcinoma
• Interventions: Drug: Atezolizumab

• 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

Study Timeline

• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-28
• Study Start: 2017-11-29
• Status Verified: 2022-08
• Primary Completion: 2022-08-12
• Study Completion: 2022-08-12
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1758

Inclusion Criteria

• Participants who are administered with atezolizumab for the locally approved indications

Exclusion Criteria

• 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

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Kosin University Gospel 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

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