Clinical trial NCT03117049: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2017-04-17
Enrollment: 550
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC)
timeFrame: Approximately 32 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 32 months
measure: Objective Response Rate (ORR [as Assessed by the IRRC])
timeFrame: Approximately 32 months
measure: Disease Control Rate (DCR [as Assessed by the IRRC])
timeFrame: Approximately 32 months
measure: Duration of Response (DOR [as Assessed by the IRRC])
timeFrame: Approximately 32 months
measure: Best Overall Response (BOR [as Assessed by the IRRC])
timeFrame: Approximately 32 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Clinical Site2
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Clinical Site3
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Clinical Site4
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Clinical Site
state: Aichi
city: Toyoake
country: Japan
facility: Aichi Clinical Site
state: Aichi
city: Hirosaki
country: Japan
facility: Aomori Clinical Site2
state: Aomori
city: Hirosaki
country: Japan
facility: Aomori Clinical Site
state: Aomori
city: Yachiyo
country: Japan
facility: Chiba Clinical Site
state: Chiba
city: Matsuyama
country: Japan
facility: Ehime Clinical Site
state: Ehime
city: Iizuka
country: Japan
facility: Fukuoka Clinical Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Fukuoka Clinical Site
state: Fukuoka
city: Koga
country: Japan
facility: Fukuoka Clinical Site
state: Fukuoka
city: Kurume
country: Japan
facility: Fukuoka Clinical Site
state: Fukuoka
city: Kōriyama
country: Japan
facility: Fukushima Clinical Site
state: Fukushima
city: Ota
country: Japan
facility: Gunma Clinical Site
state: Gunma
city: Shibukawa
country: Japan
facility: Gunma Clinical Site
state: Gunma
city: Asahikawa
country: Japan
facility: Hokkaido Clinical Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site2
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Amagasaki
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Himeji
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Itami
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Kobe
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Takarazuka
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Higashiibaraki
country: Japan
facility: Ibaraki Clinical Site
state: Ibaraki
city: Kasama
country: Japan
facility: Ibaraki Clinical Site
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Ibaraki Clinical Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Ishikawa Clinical Site2
state: Ishikawa
city: Kanazawa
country: Japan
facility: Ishikawa Clinical Site3
state: Ishikawa
city: Kanazawa
country: Japan
facility: Ishikawa Clinical Site
state: Ishikawa
city: Morioka
country: Japan
facility: Iwate Clinical Site
state: Iwate
city: Isehara
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Kanagawa Clinical Site2
state: Kanagawa
city: Kawasaki
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site2
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site3
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Koshi
country: Japan
facility: Kumamoto Clinical Site
state: Kumamoto
city: Jōyō
country: Japan
facility: Kyoto Clinical Site
state: Kyoto
city: Tsu
country: Japan
facility: Mie Clinical Site
state: Mie
city: Natori
country: Japan
facility: Miyagi Clinical Site
state: Miyagi
city: Sendai
country: Japan
facility: Miyagi Clinical Site
state: Miyagi
city: Matsumoto
country: Japan
facility: Nagano Clinical Site
state: Nagano
city: Ōmura
country: Japan
facility: Nagasaki Clinical Site
state: Nagasaki
city: Ikoma
country: Japan
facility: Nara Clinical Site
state: Nara
city: Nagaoka
country: Japan
facility: Niigata Clinical Site
state: Niigata
city: Beppu
country: Japan
facility: Oita Clinical Site
state: Oita
city: Yufu
country: Japan
facility: Oita Clinical Site
state: Oita
city: Osaka
country: Japan
facility: Osaka Clinical Site2
state: Osaka Clinical Site
city: Habikino
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Hirakata
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Kishiwada
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Osakasayama
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Sakai
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Toyonaka
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Ureshino
country: Japan
facility: Saga Clinical Site
state: Saga
city: Hidaka
country: Japan
facility: Saitama Clinical Site
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Saitama Clinical Site
state: Saitama
city: Izumo
country: Japan
facility: Shimane Clinical Site
state: Shimane
city: Hamamatsu
country: Japan
facility: Shizuoka Clinical Site
state: Shizuoka
city: Sunto-gun
country: Japan
facility: Shizuoka Clinical Site
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Tokyo Clinical Site2
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Bunkyō-Ku
country: Japan
facility: Tokyo Clinical Site2
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Clinical Site2
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Fuchū
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Kiyose
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Meguro
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Shibuya
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Clinical Site2
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Clinical Site3
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Tachikawa
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Yonago
country: Japan
facility: Tottori Clinical Site
state: Tottori
city: Iwakuni
country: Japan
facility: Yamaguchi Clinical Site
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba Clinical Site2
city: Chiba
country: Japan
facility: Chiba Clinical Site
city: Fukui
country: Japan
facility: Fukui Clinical Site
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site2
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site3
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site4
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site
city: Gifu
country: Japan
facility: Gifu Clinical Site2
city: Gifu
country: Japan
facility: Gifu Clinical Site
city: Hiroshima
country: Japan
facility: Hiroshima Clinical Site2
city: Hiroshima
country: Japan
facility: Hiroshima Clinical Site
city: Kochi
country: Japan
facility: Kochi Clinical Site
city: Kumamoto
country: Japan
facility: Kumamoto Clinical Site
city: Kyoto
country: Japan
facility: Kyoto Clinical Site
city: Nagasaki
country: Japan
facility: Nagasaki Clinical Site
city: Niigata
country: Japan
facility: Niigata Clinical Site2
city: Niigata
country: Japan
facility: Niigata Clinical Site
city: Okayama
country: Japan
facility: Okayama Clinical Site2
city: Okayama
country: Japan
facility: Okayama Clinical Site
city: Osaka
country: Japan
facility: Osaka Clinical Site3
city: Osaka
country: Japan
facility: Osaka Clinical Site
city: Tokushima
country: Japan
facility: Tokushima Clinical Site
city: Toyama
country: Japan
facility: Toyama Clinical Site2
city: Toyama
country: Japan
facility: Toyama Clinical Site
city: Wakayama
country: Japan
facility: Wakayama Clinical Site
city: Yamaguchi
country: Japan
facility: Yamaguchi Clinical Site
city: Ōita
country: Japan
facility: Oita Clinical Site
city: Cheongju-si
country: Korea, Republic of
facility: Chungcheongbuk-do Clinical Site
state: Chungcheongbuk-do
city: Wŏnju
country: Korea, Republic of
facility: Gangwon-Do Clinical Site
state: Gangwon-Do
city: Seongnam-si
country: Korea, Republic of
facility: Gyeonggi-do Clinical Site2
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Gyeonggi-do Clinical Site
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Gyeonggi-do Clinical Site
state: Gyeonggi-do
city: Jinju-si
country: Korea, Republic of
facility: Gyeongsangnam-do Clinical Site
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
facility: Busan Clinical Site
city: Daegu
country: Korea, Republic of
facility: Daegu Clinical Site
city: Incheon
country: Korea, Republic of
facility: Incheon Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site2
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site3
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site4
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site5
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site6
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Changhua
country: Taiwan
facility: Changhua Clinical Site
city: Chiayi City
country: Taiwan
facility: Chiayi Clinical Site
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site2
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site3
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site
city: Taichung
country: Taiwan
facility: Taichung Clinical Site
city: Tainan
country: Taiwan
facility: Tainan Clinical Site
city: Taipei
country: Taiwan
facility: Taipei Clinical Site2
city: Taipei
country: Taiwan
facility: Taipei Clinical Site
city: Taoyuan
country: Taiwan
facility: Taoyuan Clinical Site
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Shigeru Takahashi
role: STUDY_DIRECTOR
References: