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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind Trial in Subjects With Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117049
• Other study ID #: ONO-4538-52
• Status: Completed
• Phase: Phase 3
• Start date: June 13, 2017
• Est. completion date: December 4, 2023

Study information

• Verified date: May 2024
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: December 4, 2023
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• 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.
• Carboplatin
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.
• Paclitaxel
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
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.

Locations

Country	Name	City	State
Japan	Hyogo Clinical Site	Akashi	Hyogo
Japan	Hyogo Clinical Site	Amagasaki	Hyogo
Japan	Hokkaido Clinical Site	Asahikawa	Hokkaido
Japan	Oita Clinical Site	Beppu	Oita
Japan	Tokyo Clinical Site	Bunkyo-ku	Tokyo
Japan	Tokyo Clinical Site2	Bunkyo-Ku	Tokyo
Japan	Tokyo Clinical Site2	Bunkyo-ku	Tokyo
Japan	Chiba Clinical Site	Chiba
Japan	Chiba Clinical Site2	Chiba
Japan	Tokyo Clinical Site	Chuo-ku	Tokyo
Japan	Tokyo Clinical Site2	Chuo-ku	Tokyo
Japan	Tokyo Clinical Site	Fuchu	Tokyo
Japan	Fukui Clinical Site	Fukui
Japan	Fukuoka Clinical Site	Fukuoka
Japan	Fukuoka Clinical Site2	Fukuoka
Japan	Fukuoka Clinical Site3	Fukuoka
Japan	Fukuoka Clinical Site4	Fukuoka
Japan	Gifu Clinical Site	Gifu
Japan	Gifu Clinical Site2	Gifu
Japan	Osaka Clinical Site	Habikino	Osaka
Japan	Shizuoka Clinical Site	Hamamatsu	Shizuoka
Japan	Saitama Clinical Site	Hidaka	Saitama
Japan	Ibaraki Clinical Site	Higashiibaraki	Ibaraki
Japan	Hyogo Clinical Site	Himeji	Hyogo
Japan	Osaka Clinical Site	Hirakata	Osaka
Japan	Aomori Clinical Site	Hirosaki	Aomori
Japan	Aomori Clinical Site2	Hirosaki	Aomori
Japan	Hiroshima Clinical Site	Hiroshima
Japan	Hiroshima Clinical Site2	Hiroshima
Japan	Fukuoka Clinical Site	Iizuka	Fukuoka
Japan	Nara Clinical Site	Ikoma	Nara
Japan	Kanagawa Clinical Site	Isehara	Kanagawa
Japan	Tokyo Clinical Site	Itabashi-ku	Tokyo
Japan	Hyogo Clinical Site	Itami	Hyogo
Japan	Yamaguchi Clinical Site	Iwakuni	Yamaguchi
Japan	Shimane Clinical Site	Izumo	Shimane
Japan	Kyoto Clinical Site	Joyo	Kyoto
Japan	Ishikawa Clinical Site	Kanazawa	Ishikawa
Japan	Ishikawa Clinical Site2	Kanazawa	Ishikawa
Japan	Ishikawa Clinical Site3	Kanazawa	Ishikawa
Japan	Ibaraki Clinical Site	Kasama	Ibaraki
Japan	Kanagawa Clinical Site	Kawasaki	Kanagawa
Japan	Kanagawa Clinical Site2	Kawasaki	Kanagawa
Japan	Osaka Clinical Site	Kishiwada	Osaka
Japan	Saitama Clinical Site	Kitaadachi-gun	Saitama
Japan	Fukuoka Clinical Site	Kitakyushu	Fukuoka
Japan	Tokyo Clinical Site	Kiyose	Tokyo
Japan	Hyogo Clinical Site	Kobe	Hyogo
Japan	Kochi Clinical Site	Kochi
Japan	Fukuoka Clinical Site	Koga	Fukuoka
Japan	Fukushima Clinical Site	Koriyama	Fukushima
Japan	Kumamoto Clinical Site	Koshi	Kumamoto
Japan	Tokyo Clinical Site	Koto-ku	Tokyo
Japan	Kumamoto Clinical Site	Kumamoto
Japan	Fukuoka Clinical Site	Kurume	Fukuoka
Japan	Kyoto Clinical Site	Kyoto
Japan	Nagano Clinical Site	Matsumoto	Nagano
Japan	Ehime Clinical Site	Matsuyama	Ehime
Japan	Tokyo Clinical Site	Meguro	Tokyo
Japan	Tokyo Clinical Site	Minato-ku	Tokyo
Japan	Tokyo Clinical Site	Mitaka-shi	Tokyo
Japan	Iwate Clinical Site	Morioka	Iwate
Japan	Niigata Clinical Site	Nagaoka	Niigata
Japan	Nagasaki Clinical Site	Nagasaki
Japan	Aichi Clinical Site	Nagoya	Aichi
Japan	Aichi Clinical Site2	Nagoya	Aichi
Japan	Aichi Clinical Site3	Nagoya	Aichi
Japan	Aichi Clinical Site4	Nagoya	Aichi
Japan	Miyagi Clinical Site	Natori	Miyagi
Japan	Niigata Clinical Site	Niigata
Japan	Niigata Clinical Site2	Niigata
Japan	Hyogo Clinical Site	Nishinomiya	Hyogo
Japan	Oita Clinical Site	Oita
Japan	Okayama Clinical Site	Okayama
Japan	Okayama Clinical Site2	Okayama
Japan	Nagasaki Clinical Site	Omura	Nagasaki
Japan	Osaka Clinical Site	Osaka
Japan	Osaka Clinical Site2	Osaka	Osaka Clinical Site
Japan	Osaka Clinical Site3	Osaka
Japan	Osaka Clinical Site	Osakasayama	Osaka
Japan	Gunma Clinical Site	Ota	Gunma
Japan	Kanagawa Clinical Site	Sagamihara	Kanagawa
Japan	Osaka Clinical Site	Sakai	Osaka
Japan	Hokkaido Clinical Site	Sapporo	Hokkaido
Japan	Hokkaido Clinical Site2	Sapporo	Hokkaido
Japan	Miyagi Clinical Site	Sendai	Miyagi
Japan	Gunma Clinical Site	Shibukawa	Gunma
Japan	Tokyo Clinical Site	Shibuya	Tokyo
Japan	Tokyo Clinical Site	Shinjuku-ku	Tokyo
Japan	Tokyo Clinical Site2	Shinjuku-Ku	Tokyo
Japan	Tokyo Clinical Site3	Shinjuku-Ku	Tokyo
Japan	Shizuoka Clinical Site	Sunto-gun	Shizuoka
Japan	Tokyo Clinical Site	Tachikawa	Tokyo
Japan	Hyogo Clinical Site	Takarazuka	Hyogo
Japan	Tokushima Clinical Site	Tokushima
Japan	Toyama Clinical Site	Toyama
Japan	Toyama Clinical Site2	Toyama
Japan	Aichi Clinical Site	Toyoake	Aichi
Japan	Osaka Clinical Site	Toyonaka	Osaka
Japan	Mie Clinical Site	Tsu	Mie
Japan	Ibaraki Clinical Site	Tsuchiura	Ibaraki
Japan	Saga Clinical Site	Ureshino	Saga
Japan	Wakayama Clinical Site	Wakayama
Japan	Chiba Clinical Site	Yachiyo	Chiba
Japan	Yamaguchi Clinical Site	Yamaguchi
Japan	Kanagawa Clinical Site	Yokohama	Kanagawa
Japan	Kanagawa Clinical Site2	Yokohama	Kanagawa
Japan	Kanagawa Clinical Site3	Yokohama	Kanagawa
Japan	Tottori Clinical Site	Yonago	Tottori
Japan	Oita Clinical Site	Yufu	Oita
Korea, Republic of	Busan Clinical Site	Busan
Korea, Republic of	Chungcheongbuk-do Clinical Site	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	Daegu Clinical Site	Daegu
Korea, Republic of	Incheon Clinical Site	Incheon
Korea, Republic of	Gyeongsangnam-do Clinical Site	Jinju-si	Gyeongsangnam-do
Korea, Republic of	Gyeonggi-do Clinical Site	Seongnam-si	Gyeonggi-do
Korea, Republic of	Gyeonggi-do Clinical Site2	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul Clinical Site	Seoul
Korea, Republic of	Seoul Clinical Site2	Seoul
Korea, Republic of	Seoul Clinical Site3	Seoul
Korea, Republic of	Seoul Clinical Site4	Seoul
Korea, Republic of	Seoul Clinical Site5	Seoul
Korea, Republic of	Seoul Clinical Site6	Seoul
Korea, Republic of	Gyeonggi-do Clinical Site	Suwon	Gyeonggi-do
Korea, Republic of	Gangwon-Do Clinical Site	Wonju	Gangwon-Do
Taiwan	Changhua Clinical Site	Changhua
Taiwan	Chiayi Clinical Site	Chiayi City
Taiwan	Kaohsiung Clinical Site	Kaohsiung
Taiwan	Kaohsiung Clinical Site2	Kaohsiung
Taiwan	Kaohsiung Clinical Site3	Kaohsiung
Taiwan	Taichung Clinical Site	Taichung
Taiwan	Tainan Clinical Site	Tainan
Taiwan	Taipei Clinical Site	Taipei
Taiwan	Taipei Clinical Site2	Taipei
Taiwan	Taoyuan Clinical Site	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd	Bristol-Myers Squibb

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 32 months
Secondary	Overall Survival (OS)		Approximately 32 months
Secondary	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.	Approximately 32 months
Secondary	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.	Approximately 32 months
Secondary	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.	Approximately 32 months
Secondary	Best Overall Response (BOR [as Assessed by the IRRC])		Approximately 32 months