Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT03117049
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 550
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONO-4538 group ONO-4538 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 group Bevacizumab 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. Placebo group Placebo 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. ONO-4538 group Carboplatin 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. ONO-4538 group Paclitaxel 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. ONO-4538 group Bevacizumab 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 group Carboplatin 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. Placebo group Paclitaxel 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC) Approximately 32 months 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
Name Time Method Overall Survival (OS) Approximately 32 months Best Overall Response (BOR [as Assessed by the IRRC]) Approximately 32 months Disease Control Rate (DCR [as Assessed by the IRRC]) Approximately 32 months 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]) Approximately 32 months The lower and upper limits of 95% CI for the median are censored value in the both groups.
Objective Response Rate (ORR [as Assessed by the IRRC]) Approximately 32 months 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.
Trial Locations
- Locations (84)
Chungcheongbuk-do Clinical Site
🇰🇷Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Aichi Clinical Site
🇯🇵Toyoake, Aichi, Japan
Aichi Clinical Site2
🇯🇵Nagoya, Aichi, Japan
Aichi Clinical Site3
🇯🇵Nagoya, Aichi, Japan
Aomori Clinical Site2
🇯🇵Hirosaki, Aomori, Japan
Aomori Clinical Site
🇯🇵Hirosaki, Aomori, Japan
Gunma Clinical Site
🇯🇵Shibukawa, Gunma, Japan
Hokkaido Clinical Site2
🇯🇵Sapporo, Hokkaido, Japan
Ishikawa Clinical Site3
🇯🇵Kanazawa, Ishikawa, Japan
Ishikawa Clinical Site
🇯🇵Kanazawa, Ishikawa, Japan
Kanagawa Clinical Site
🇯🇵Yokohama, Kanagawa, Japan
Kanagawa Clinical Site3
🇯🇵Yokohama, Kanagawa, Japan
Nagano Clinical Site
🇯🇵Matsumoto, Nagano, Japan
Niigata Clinical Site
🇯🇵Niigata, Japan
Osaka Clinical Site2
🇯🇵Osaka, Osaka Clinical Site, Japan
Saga Clinical Site
🇯🇵Ureshino, Saga, Japan
Shizuoka Clinical Site
🇯🇵Sunto-gun, Shizuoka, Japan
Fukuoka Clinical Site3
🇯🇵Fukuoka, Japan
Niigata Clinical Site2
🇯🇵Niigata, Japan
Hiroshima Clinical Site2
🇯🇵Hiroshima, Japan
Okayama Clinical Site
🇯🇵Okayama, Japan
Tokushima Clinical Site
🇯🇵Tokushima, Japan
Gyeonggi-do Clinical Site
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Gyeongsangnam-do Clinical Site
🇰🇷Jinju-si, Gyeongsangnam-do, 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 Site6
🇰🇷Seoul, Korea, Republic of
Chiayi Clinical Site
🇨🇳Chiayi City, Taiwan
Kaohsiung Clinical Site2
🇨🇳Kaohsiung, Taiwan
Taichung Clinical Site
🇨🇳Taichung, Taiwan
Taipei Clinical Site2
🇨🇳Taipei, Taiwan
Kanagawa Clinical Site2
🇯🇵Yokohama, Kanagawa, Japan
Osaka Clinical Site
🇯🇵Osaka, Japan
Tottori Clinical Site
🇯🇵Yonago, Tottori, Japan
Ishikawa Clinical Site2
🇯🇵Kanazawa, Ishikawa, Japan
Saitama Clinical Site
🇯🇵Kitaadachi-gun, Saitama, Japan
Fukuoka Clinical Site4
🇯🇵Fukuoka, Japan
Chiba Clinical Site
🇯🇵Chiba, Japan
Fukushima Clinical Site
🇯🇵Kōriyama, Fukushima, Japan
Iwate Clinical Site
🇯🇵Morioka, Iwate, Japan
Kumamoto Clinical Site
🇯🇵Kumamoto, Japan
Ehime Clinical Site
🇯🇵Matsuyama, Ehime, Japan
Ibaraki Clinical Site
🇯🇵Tsuchiura, Ibaraki, Japan
Kyoto Clinical Site
🇯🇵Kyoto, Japan
Miyagi Clinical Site
🇯🇵Sendai, Miyagi, Japan
Yamaguchi Clinical Site
🇯🇵Yamaguchi, Japan
Chiba Clinical Site2
🇯🇵Chiba, Japan
Gifu Clinical Site2
🇯🇵Gifu, Japan
Gifu Clinical Site
🇯🇵Gifu, Japan
Changhua Clinical Site
🇨🇳Changhua, Taiwan
Tokyo Clinical Site2
🇯🇵Shinjuku-Ku, Tokyo, Japan
Fukuoka Clinical Site
🇯🇵Fukuoka, Japan
Hokkaido Clinical Site
🇯🇵Sapporo, Hokkaido, Japan
Mie Clinical Site
🇯🇵Tsu, Mie, Japan
Shimane Clinical Site
🇯🇵Izumo, Shimane, Japan
Hiroshima Clinical Site
🇯🇵Hiroshima, Japan
Taoyuan Clinical Site
🇨🇳Taoyuan, Taiwan
Hyogo Clinical Site
🇯🇵Takarazuka, Hyogo, Japan
Fukuoka Clinical Site2
🇯🇵Fukuoka, Japan
Kochi Clinical Site
🇯🇵Kochi, Japan
Okayama Clinical Site2
🇯🇵Okayama, Japan
Toyama Clinical Site
🇯🇵Toyama, Japan
Tainan Clinical Site
🇨🇳Tainan, Taiwan
Tokyo Clinical Site3
🇯🇵Shinjuku-Ku, Tokyo, Japan
Toyama Clinical Site2
🇯🇵Toyama, Japan
Gangwon-Do Clinical Site
🇰🇷Wŏnju, Gangwon-Do, Korea, Republic of
Aichi Clinical Site4
🇯🇵Nagoya, Aichi, Japan
Oita Clinical Site
🇯🇵Ōita, Japan
Nara Clinical Site
🇯🇵Ikoma, Nara, Japan
Nagasaki Clinical Site
🇯🇵Nagasaki, Japan
Tokyo Clinical Site
🇯🇵Tachikawa, Tokyo, Japan
Fukui Clinical Site
🇯🇵Fukui, Japan
Osaka Clinical Site3
🇯🇵Osaka, Japan
Wakayama Clinical Site
🇯🇵Wakayama, Japan
Gyeonggi-do Clinical Site2
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Busan Clinical Site
🇰🇷Busan, Korea, Republic of
Daegu Clinical Site
🇰🇷Daegu, Korea, Republic of
Incheon Clinical Site
🇰🇷Incheon, Korea, Republic of
Seoul Clinical Site5
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site
🇰🇷Seoul, Korea, Republic of
Kaohsiung Clinical Site
🇨🇳Kaohsiung, Taiwan
Kaohsiung Clinical Site3
🇨🇳Kaohsiung, Taiwan
Taipei Clinical Site
🇨🇳Taipei, Taiwan