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CompletedNCT03232593Updated Aug 24, 2022

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

An observational study in Urothelial Carcinoma, Carcinoma, Non-Small Cell Lung and Small Cell Lung Carcinoma, sponsored by Hoffmann-La Roche. Completed at 56 sites in Korea, Republic of. Per ClinicalTrials.gov, last updated 2022-08-24.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,758
Sex
All
01

Study 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.

02

Conditions studied

  • Urothelial Carcinoma
  • Carcinoma, Non-Small Cell Lung
  • Small Cell Lung Carcinoma
  • Triple Negative Breast Carcinoma
  • Hepatocellular Carcinoma
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 1,758 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants who are administered with atezolizumab at physician's discretion will be enrolled for the study.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Participants with a known hypersensitivity to atezolizumab or to any of the excipients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,758 participants (actual)
Patient registry
No

Groups and cohorts

  • Participants who Receive 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.

    Drug: Atezolizumab

Interventions

  • DrugAtezolizumab

    Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.

    Also known as: Tecentriq

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

    Time frame: Approximately 6 years

Secondary outcomes

  1. Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    Time frame: Approximately 6 years

  2. Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1

    Time frame: Approximately 6 years

  3. Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1

    Time frame: Approximately 6 years

  4. Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1

    Time frame: Approximately 6 years

07

Study locations

56 sites
  • Dongnam Inst.of Radiological & Medical Sciences
    Busan, 46033, Korea, Republic of
  • Inje University Busan Paik Hospital
    Busan, 47392, Korea, Republic of
  • Inje university Haeundae Paik Hospital
    Busan, 48108, Korea, Republic of
  • Dong-A University Hospital
    Busan, 49201, Korea, Republic of
  • Pusan National University Hospital
    Busan, 49241, Korea, Republic of
  • Kosin University Gospel Hospital
    Busan, 49267, Korea, Republic of
  • Donga Uni Medical Center; Pulmonary
    Busan, 602-715, Korea, Republic of
  • Pusan University Hospital
    Busan, 602-739, Korea, Republic of
  • Pusan University Hospital; Hemato-oncology
    Busan, Korea, Republic of
  • Kyungpook National University Medical Center
    Daegu, 41404, Korea, Republic of
  • Keimyung University Dongsan Medical Center
    Daegu, 41931, Korea, Republic of
  • Daegu Catholic University Medical Center
    Daegu, 42472, Korea, Republic of
  • Keimyung University Dongsan Hospital; Pulmonology
    Daegu, 42601, Korea, Republic of
  • Konyang University Hospital
    Daejeon, 35365, Korea, Republic of
  • Hallym University Medical Center Chuncheon Sacred Heart Hospital
    Gangwon-do, 24253, Korea, Republic of
  • Yonsei University Wonju Severance Christian Hospital
    Gangwon-do, 26426, Korea, Republic of
  • Gangneung Asan Hospital
    Gangwon-do, Korea, Republic of
  • Uijeongbu St. Mary's Hospital
    Gyeonggi-do, 11765, Korea, Republic of
  • CHA Bundang Medical Center
    Gyeonggi-do, 13496, Korea, Republic of
  • Hallym University Sacred Heart Hospital
    Gyeonggi-do, 14068, Korea, Republic of
  • Soonchunhyang University Bucheon Hospital
    Gyeonggi-do, 14584, Korea, Republic of
  • Bucheon St Mary's hospital
    Gyeonggi-do, 14647, Korea, Republic of
  • Korea University Ansan Hospital
    Gyeonggi-do, 15355, Korea, Republic of
  • St. Vincent's Hospital
    Gyeonggi-do, 16247, Korea, Republic of
  • Pusan National University Yangsan Hospital
    Gyeongsangnam-do, 50612, Korea, Republic of
  • Hallym University Dongtan Sacred Heart Hospital
    Hwaseong Si, Korea, Republic of
  • Chonbuk National University Hospital
    Jeollabuk-do, 54907, Korea, Republic of
  • Chonnam National University Hwasun Hospital
    Jeollanam-do, 58128, Korea, Republic of
  • Wonkwang University School of Medicine & Hospital
    Jeonlabuk-do, 54538, Korea, Republic of
  • Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
    Seoul, 01812, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, 02841, Korea, Republic of
  • Kangbuk Samsung Hospital
    Seoul, 03181, Korea, Republic of
  • Eunpyeong St. Mary's Hoapital
    Seoul, 03312, Korea, Republic of
  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, Korea, Republic of
  • Severance Hospital, Yonsei University
    Seoul, 03722, Korea, Republic of
  • Soonchunhyang University Hospital
    Seoul, 04401, Korea, Republic of
  • Hanyang University Medical Center
    Seoul, 04763, Korea, Republic of
  • Gangdong Kyung Hee University Hospital
    Seoul, 05278, Korea, Republic of
  • VHS Medical Center
    Seoul, 05368, Korea, Republic of
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
  • Gangnam Severance Hospital
    Seoul, 06273, Korea, Republic of
  • Samsung Medical Center
    Seoul, 06351, Korea, Republic of
  • Seoul St Mary's Hospital
    Seoul, 06591, Korea, Republic of
  • ChungAng University Hospital
    Seoul, 06973, Korea, Republic of
  • Borame Medical Center
    Seoul, 07061, Korea, Republic of
  • Yeouido St. Mary's Hospital
    Seoul, 07345, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, 08308, Korea, Republic of
  • Severance Hospital, Yonsei University Health System; Oncology
    Seoul, 120-752, Korea, Republic of
  • Samsung Medical Centre; Division of Hematology/Oncology
    Seoul, 135-710, Korea, Republic of
  • Ewha Womans University Mokdong Hospital; Urology
    Seoul, Korea, Republic of
  • Korea Uni Anam Hospital; Internal Medicine
    Seoul, Korea, Republic of
  • SoonChunHyang University Hospital Seoul
    Seoul, Korea, Republic of
  • Ulsan University Hosiptal
    Ulsan, 44033, Korea, Republic of
  • Ulsan University Hospital
    Ulsan, 44033, Korea, Republic of
  • Yonsei University Wonju Severance Christian Hospital
    Wonju-Si, 220-701, Korea, Republic of
  • Pusan National University Yangsan Hospital; hemato-oncology
    Yangsan, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03232593
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jul 28, 2017
Start date
Nov 29, 2017
Primary completion
Aug 12, 2022
Completion
Aug 12, 2022
Last update
Aug 24, 2022

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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