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Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ONO-4538
Carboplatin
Paclitaxel
Bevacizumab
Placebo
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with histologically- or cytologically-confirmed non-squamous non-small cell lung cancer
  • Subjects who received a diagnosis of stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation according to the UICC-TNM Classification (7th edition) with no prior systemic anticancer therapy
  • Subjects with at least one measurable lesion by radiographic tumor assessments per RECIST 1.1 criteria
  • Subjects who are able to provide tumor tissue specimens.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Exclusion Criteria:

  • Subjects with known EGFR mutations, including deletions in exon 19 and exon 21 (L858R) substitution mutations.
  • Subjects with known ALK translocations.
  • Complication or history of severe hypersensitivity reactions to antibody products or platinum-containing compounds
  • Subjects with autoimmune disease or known chronic or recurrent autoimmune disease.
  • Subjects with multiple cancer.

Sites / Locations

  • Aichi Clinical Site2
  • Aichi Clinical Site3
  • Aichi Clinical Site4
  • Aichi Clinical Site
  • Aichi Clinical Site
  • Aomori Clinical Site2
  • Aomori Clinical Site
  • Chiba Clinical Site
  • Ehime Clinical Site
  • Fukuoka Clinical Site
  • Fukuoka Clinical Site
  • Fukuoka Clinical Site
  • Fukuoka Clinical Site
  • Fukushima Clinical Site
  • Gunma Clinical Site
  • Gunma Clinical Site
  • Hokkaido Clinical Site
  • Hokkaido Clinical Site2
  • Hokkaido Clinical Site
  • Hyogo Clinical Site
  • Hyogo Clinical Site
  • Hyogo Clinical Site
  • Hyogo Clinical Site
  • Hyogo Clinical Site
  • Hyogo Clinical Site
  • Hyogo Clinical Site
  • Ibaraki Clinical Site
  • Ibaraki Clinical Site
  • Ibaraki Clinical Site
  • Ishikawa Clinical Site2
  • Ishikawa Clinical Site3
  • Ishikawa Clinical Site
  • Iwate Clinical Site
  • Kanagawa Clinical Site
  • Kanagawa Clinical Site2
  • Kanagawa Clinical Site
  • Kanagawa Clinical Site
  • Kanagawa Clinical Site2
  • Kanagawa Clinical Site3
  • Kanagawa Clinical Site
  • Kumamoto Clinical Site
  • Kyoto Clinical Site
  • Mie Clinical Site
  • Miyagi Clinical Site
  • Miyagi Clinical Site
  • Nagano Clinical Site
  • Nagasaki Clinical Site
  • Nara Clinical Site
  • Niigata Clinical Site
  • Oita Clinical Site
  • Oita Clinical Site
  • Osaka Clinical Site2
  • Osaka Clinical Site
  • Osaka Clinical Site
  • Osaka Clinical Site
  • Osaka Clinical Site
  • Osaka Clinical Site
  • Osaka Clinical Site
  • Saga Clinical Site
  • Saitama Clinical Site
  • Saitama Clinical Site
  • Shimane Clinical Site
  • Shizuoka Clinical Site
  • Shizuoka Clinical Site
  • Tokyo Clinical Site2
  • Tokyo Clinical Site
  • Tokyo Clinical Site2
  • Tokyo Clinical Site2
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site2
  • Tokyo Clinical Site3
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tottori Clinical Site
  • Yamaguchi Clinical Site
  • Chiba Clinical Site2
  • Chiba Clinical Site
  • Fukui Clinical Site
  • Fukuoka Clinical Site2
  • Fukuoka Clinical Site3
  • Fukuoka Clinical Site4
  • Fukuoka Clinical Site
  • Gifu Clinical Site2
  • Gifu Clinical Site
  • Hiroshima Clinical Site2
  • Hiroshima Clinical Site
  • Kochi Clinical Site
  • Kumamoto Clinical Site
  • Kyoto Clinical Site
  • Nagasaki Clinical Site
  • Niigata Clinical Site2
  • Niigata Clinical Site
  • Okayama Clinical Site2
  • Okayama Clinical Site
  • Osaka Clinical Site3
  • Osaka Clinical Site
  • Tokushima Clinical Site
  • Toyama Clinical Site2
  • Toyama Clinical Site
  • Wakayama Clinical Site
  • Yamaguchi Clinical Site
  • Oita Clinical Site
  • Chungcheongbuk-do Clinical Site
  • Gangwon-Do Clinical Site
  • Gyeonggi-do Clinical Site2
  • Gyeonggi-do Clinical Site
  • Gyeonggi-do Clinical Site
  • Gyeongsangnam-do Clinical Site
  • Busan Clinical Site
  • Daegu Clinical Site
  • Incheon Clinical Site
  • Seoul Clinical Site2
  • Seoul Clinical Site3
  • Seoul Clinical Site4
  • Seoul Clinical Site5
  • Seoul Clinical Site6
  • Seoul Clinical Site
  • Changhua Clinical Site
  • Chiayi Clinical Site
  • Kaohsiung Clinical Site2
  • Kaohsiung Clinical Site3
  • Kaohsiung Clinical Site
  • Taichung Clinical Site
  • Tainan Clinical Site
  • Taipei Clinical Site2
  • Taipei Clinical Site
  • Taoyuan Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ONO-4538 group

Placebo group

Arm Description

ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC)
PFS (as assessed by the IRRC) will be calculated using the following formula : PFS (days) = "date when overall response is assessed as progressive disease (PD) or date of death (for any reason), whichever comes first" - "date of randomization" + 1. Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.

Secondary Outcome Measures

Overall Survival (OS)
Objective Response Rate (ORR [as Assessed by the IRRC])
ORR represents the proportion of subjects whose best overall response was assessed as complete response (CR) or partial response (PR). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.
Disease Control Rate (DCR [as Assessed by the IRRC])
DCR represents the proportion of subjects whose best overall response was assessed as CR, PR, or stable disease (SD). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.
Duration of Response (DOR [as Assessed by the IRRC])
The lower and upper limits of 95% CI for the median are censored value in the both groups.
Best Overall Response (BOR [as Assessed by the IRRC])

Full Information

First Posted
April 12, 2017
Last Updated
June 28, 2022
Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03117049
Brief Title
Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
Official Title
A Multicenter, Randomized, Double-Blind Trial in Subjects With Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation in a multicenter, randomized, double-blind study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
550 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ONO-4538 group
Arm Type
Experimental
Arm Description
ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
ONO-4538
Intervention Description
360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC)
Description
PFS (as assessed by the IRRC) will be calculated using the following formula : PFS (days) = "date when overall response is assessed as progressive disease (PD) or date of death (for any reason), whichever comes first" - "date of randomization" + 1. Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.
Time Frame
Approximately 32 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Approximately 32 months
Title
Objective Response Rate (ORR [as Assessed by the IRRC])
Description
ORR represents the proportion of subjects whose best overall response was assessed as complete response (CR) or partial response (PR). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.
Time Frame
Approximately 32 months
Title
Disease Control Rate (DCR [as Assessed by the IRRC])
Description
DCR represents the proportion of subjects whose best overall response was assessed as CR, PR, or stable disease (SD). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.
Time Frame
Approximately 32 months
Title
Duration of Response (DOR [as Assessed by the IRRC])
Description
The lower and upper limits of 95% CI for the median are censored value in the both groups.
Time Frame
Approximately 32 months
Title
Best Overall Response (BOR [as Assessed by the IRRC])
Time Frame
Approximately 32 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with histologically- or cytologically-confirmed non-squamous non-small cell lung cancer Subjects who received a diagnosis of stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation according to the UICC-TNM Classification (7th edition) with no prior systemic anticancer therapy Subjects with at least one measurable lesion by radiographic tumor assessments per RECIST 1.1 criteria Subjects who are able to provide tumor tissue specimens. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 Exclusion Criteria: Subjects with known EGFR mutations, including deletions in exon 19 and exon 21 (L858R) substitution mutations. Subjects with known ALK translocations. Complication or history of severe hypersensitivity reactions to antibody products or platinum-containing compounds Subjects with autoimmune disease or known chronic or recurrent autoimmune disease. Subjects with multiple cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeru Takahashi
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Clinical Site2
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Aichi Clinical Site3
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Aichi Clinical Site4
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Aichi Clinical Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Aichi Clinical Site
City
Toyoake
State/Province
Aichi
Country
Japan
Facility Name
Aomori Clinical Site2
City
Hirosaki
State/Province
Aomori
Country
Japan
Facility Name
Aomori Clinical Site
City
Hirosaki
State/Province
Aomori
Country
Japan
Facility Name
Chiba Clinical Site
City
Yachiyo
State/Province
Chiba
Country
Japan
Facility Name
Ehime Clinical Site
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Fukuoka Clinical Site
City
Iizuka
State/Province
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site
City
Koga
State/Province
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Fukushima Clinical Site
City
Kōriyama
State/Province
Fukushima
Country
Japan
Facility Name
Gunma Clinical Site
City
Ota
State/Province
Gunma
Country
Japan
Facility Name
Gunma Clinical Site
City
Shibukawa
State/Province
Gunma
Country
Japan
Facility Name
Hokkaido Clinical Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Hokkaido Clinical Site2
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Hokkaido Clinical Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Hyogo Clinical Site
City
Akashi
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site
City
Amagasaki
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site
City
Himeji
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site
City
Itami
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
Hyogo Clinical Site
City
Takarazuka
State/Province
Hyogo
Country
Japan
Facility Name
Ibaraki Clinical Site
City
Higashiibaraki
State/Province
Ibaraki
Country
Japan
Facility Name
Ibaraki Clinical Site
City
Kasama
State/Province
Ibaraki
Country
Japan
Facility Name
Ibaraki Clinical Site
City
Tsuchiura
State/Province
Ibaraki
Country
Japan
Facility Name
Ishikawa Clinical Site2
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Ishikawa Clinical Site3
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Ishikawa Clinical Site
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Iwate Clinical Site
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site2
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site2
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site3
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kumamoto Clinical Site
City
Koshi
State/Province
Kumamoto
Country
Japan
Facility Name
Kyoto Clinical Site
City
Jōyō
State/Province
Kyoto
Country
Japan
Facility Name
Mie Clinical Site
City
Tsu
State/Province
Mie
Country
Japan
Facility Name
Miyagi Clinical Site
City
Natori
State/Province
Miyagi
Country
Japan
Facility Name
Miyagi Clinical Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Nagano Clinical Site
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Nagasaki Clinical Site
City
Ōmura
State/Province
Nagasaki
Country
Japan
Facility Name
Nara Clinical Site
City
Ikoma
State/Province
Nara
Country
Japan
Facility Name
Niigata Clinical Site
City
Nagaoka
State/Province
Niigata
Country
Japan
Facility Name
Oita Clinical Site
City
Beppu
State/Province
Oita
Country
Japan
Facility Name
Oita Clinical Site
City
Yufu
State/Province
Oita
Country
Japan
Facility Name
Osaka Clinical Site2
City
Osaka
State/Province
Osaka Clinical Site
Country
Japan
Facility Name
Osaka Clinical Site
City
Habikino
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Hirakata
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Kishiwada
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Toyonaka
State/Province
Osaka
Country
Japan
Facility Name
Saga Clinical Site
City
Ureshino
State/Province
Saga
Country
Japan
Facility Name
Saitama Clinical Site
City
Hidaka
State/Province
Saitama
Country
Japan
Facility Name
Saitama Clinical Site
City
Kitaadachi-gun
State/Province
Saitama
Country
Japan
Facility Name
Shimane Clinical Site
City
Izumo
State/Province
Shimane
Country
Japan
Facility Name
Shizuoka Clinical Site
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
Shizuoka Clinical Site
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
Facility Name
Tokyo Clinical Site2
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site2
City
Bunkyō-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site2
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Fuchū
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Itabashi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Kiyose
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Meguro
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Mitaka-shi
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Shibuya
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site2
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site3
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Clinical Site
City
Tachikawa
State/Province
Tokyo
Country
Japan
Facility Name
Tottori Clinical Site
City
Yonago
State/Province
Tottori
Country
Japan
Facility Name
Yamaguchi Clinical Site
City
Iwakuni
State/Province
Yamaguchi
Country
Japan
Facility Name
Chiba Clinical Site2
City
Chiba
Country
Japan
Facility Name
Chiba Clinical Site
City
Chiba
Country
Japan
Facility Name
Fukui Clinical Site
City
Fukui
Country
Japan
Facility Name
Fukuoka Clinical Site2
City
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site3
City
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site4
City
Fukuoka
Country
Japan
Facility Name
Fukuoka Clinical Site
City
Fukuoka
Country
Japan
Facility Name
Gifu Clinical Site2
City
Gifu
Country
Japan
Facility Name
Gifu Clinical Site
City
Gifu
Country
Japan
Facility Name
Hiroshima Clinical Site2
City
Hiroshima
Country
Japan
Facility Name
Hiroshima Clinical Site
City
Hiroshima
Country
Japan
Facility Name
Kochi Clinical Site
City
Kochi
Country
Japan
Facility Name
Kumamoto Clinical Site
City
Kumamoto
Country
Japan
Facility Name
Kyoto Clinical Site
City
Kyoto
Country
Japan
Facility Name
Nagasaki Clinical Site
City
Nagasaki
Country
Japan
Facility Name
Niigata Clinical Site2
City
Niigata
Country
Japan
Facility Name
Niigata Clinical Site
City
Niigata
Country
Japan
Facility Name
Okayama Clinical Site2
City
Okayama
Country
Japan
Facility Name
Okayama Clinical Site
City
Okayama
Country
Japan
Facility Name
Osaka Clinical Site3
City
Osaka
Country
Japan
Facility Name
Osaka Clinical Site
City
Osaka
Country
Japan
Facility Name
Tokushima Clinical Site
City
Tokushima
Country
Japan
Facility Name
Toyama Clinical Site2
City
Toyama
Country
Japan
Facility Name
Toyama Clinical Site
City
Toyama
Country
Japan
Facility Name
Wakayama Clinical Site
City
Wakayama
Country
Japan
Facility Name
Yamaguchi Clinical Site
City
Yamaguchi
Country
Japan
Facility Name
Oita Clinical Site
City
Ōita
Country
Japan
Facility Name
Chungcheongbuk-do Clinical Site
City
Cheongju-si
State/Province
Chungcheongbuk-do
Country
Korea, Republic of
Facility Name
Gangwon-Do Clinical Site
City
Wŏnju
State/Province
Gangwon-Do
Country
Korea, Republic of
Facility Name
Gyeonggi-do Clinical Site2
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gyeonggi-do Clinical Site
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gyeonggi-do Clinical Site
City
Suwon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gyeongsangnam-do Clinical Site
City
Jinju-si
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Facility Name
Busan Clinical Site
City
Busan
Country
Korea, Republic of
Facility Name
Daegu Clinical Site
City
Daegu
Country
Korea, Republic of
Facility Name
Incheon Clinical Site
City
Incheon
Country
Korea, Republic of
Facility Name
Seoul Clinical Site2
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site3
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site4
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site5
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site6
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
Country
Korea, Republic of
Facility Name
Changhua Clinical Site
City
Changhua
Country
Taiwan
Facility Name
Chiayi Clinical Site
City
Chiayi City
Country
Taiwan
Facility Name
Kaohsiung Clinical Site2
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Clinical Site3
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Clinical Site
City
Kaohsiung
Country
Taiwan
Facility Name
Taichung Clinical Site
City
Taichung
Country
Taiwan
Facility Name
Tainan Clinical Site
City
Tainan
Country
Taiwan
Facility Name
Taipei Clinical Site2
City
Taipei
Country
Taiwan
Facility Name
Taipei Clinical Site
City
Taipei
Country
Taiwan
Facility Name
Taoyuan Clinical Site
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing URL
https://www.ono.co.jp/eng/rd/policy.html

Learn more about this trial

Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

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