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

NCT03117049 | Completed Phase 3 Results DMC

• 1 other identifier: ONO-4538-52
• Study Type: interventional
• Target: 550
• Locations: 3 countries
• Sites: 135

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Survival (OS)

  Approximately 32 months

• Objective Response Rate (ORR [as Assessed by the IRRC])

  Approximately 32 months

• Disease Control Rate (DCR [as Assessed by the IRRC])

  Approximately 32 months

• Duration of Response (DOR [as Assessed by the IRRC])

  Approximately 32 months

• Best Overall Response (BOR [as Assessed by the IRRC])

  Approximately 32 months

Study Arms (2)

ONO-4538 group

EXPERIMENTAL

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.

Drug: ONO-4538; Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab

Placebo group

PLACEBO COMPARATOR

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.

Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab; Drug: Placebo

Interventions

ONO-4538 DRUG

360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

ONO-4538 group

Carboplatin DRUG

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.

ONO-4538 group; Placebo group

Paclitaxel DRUG

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.

ONO-4538 group; Placebo group

Bevacizumab DRUG

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; Placebo group

Placebo DRUG

Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead
• Bristol-Myers Squibb: collaborator

Study Sites (135)

Aichi Clinical Site2

Nagoya, Aichi-ken, Japan

Location

Aichi Clinical Site3

Nagoya, Aichi-ken, Japan

Location

Aichi Clinical Site4

Nagoya, Aichi-ken, Japan

Location

Aichi Clinical Site

Nagoya, Aichi-ken, Japan

Location

Aichi Clinical Site

Toyoake, Aichi-ken, Japan

Location

Aomori Clinical Site2

Hirosaki, Aomori, Japan

Location

Aomori Clinical Site

Hirosaki, Aomori, Japan

Location

Chiba Clinical Site

Yachiyo, Chiba, Japan

Location

Ehime Clinical Site

Matsuyama, Ehime, Japan

Location

Fukuoka Clinical Site

Iizuka, Fukuoka, Japan

Location

Fukuoka Clinical Site

Kitakyushu, Fukuoka, Japan

Location

Fukuoka Clinical Site

Koga, Fukuoka, Japan

Location

Fukuoka Clinical Site

Kurume, Fukuoka, Japan

Location

Fukushima Clinical Site

Kōriyama, Fukushima, Japan

Location

Gunma Clinical Site

Ōta, Gunma, Japan

Location

Gunma Clinical Site

Shibukawa, Gunma, Japan

Location

Hokkaido Clinical Site

Asahikawa, Hokkaido, Japan

Location

Hokkaido Clinical Site2

Sapporo, Hokkaido, Japan

Location

Hokkaido Clinical Site

Sapporo, Hokkaido, Japan

Location

Hyogo Clinical Site

Akashi, Hyōgo, Japan

Location

Hyogo Clinical Site

Amagasaki, Hyōgo, Japan

Location

Hyogo Clinical Site

Himeji, Hyōgo, Japan

Location

Hyogo Clinical Site

Itami, Hyōgo, Japan

Location

Hyogo Clinical Site

Kobe, Hyōgo, Japan

Location

Hyogo Clinical Site

Nishinomiya, Hyōgo, Japan

Location

Hyogo Clinical Site

Takarazuka, Hyōgo, Japan

Location

Ibaraki Clinical Site

Higashiibaraki, Ibaraki, Japan

Location

Ibaraki Clinical Site

Kasama, Ibaraki, Japan

Location

Ibaraki Clinical Site

Tsuchiura, Ibaraki, Japan

Location

Ishikawa Clinical Site2

Kanazawa, Ishikawa-ken, Japan

Location

Ishikawa Clinical Site3

Kanazawa, Ishikawa-ken, Japan

Location

Ishikawa Clinical Site

Kanazawa, Ishikawa-ken, Japan

Location

Iwate Clinical Site

Morioka, Iwate, Japan

Location

Kanagawa Clinical Site

Isehara, Kanagawa, Japan

Location

Kanagawa Clinical Site2

Kawasaki, Kanagawa, Japan

Location

Kanagawa Clinical Site

Kawasaki, Kanagawa, Japan

Location

Kanagawa Clinical Site

Sagamihara, Kanagawa, Japan

Location

Kanagawa Clinical Site2

Yokohama, Kanagawa, Japan

Location

Kanagawa Clinical Site3

Yokohama, Kanagawa, Japan

Location

Kanagawa Clinical Site

Yokohama, Kanagawa, Japan

Location

Kumamoto Clinical Site

Kōshi, Kumamoto, Japan

Location

Kyoto Clinical Site

Jōyō, Kyoto, Japan

Location

Mie Clinical Site

Tsu, Mie-ken, Japan

Location

Miyagi Clinical Site

Natori-shi, Miyagi, Japan

Location

Miyagi Clinical Site

Sendai, Miyagi, Japan

Location

Nagano Clinical Site

Matsumoto, Nagano, Japan

Location

Nagasaki Clinical Site

Ōmura, Nagasaki, Japan

Location

Nara Clinical Site

Ikoma, Nara, Japan

Location

Niigata Clinical Site

Nagaoka, Niigata, Japan

Location

Oita Clinical Site

Beppu, Oita Prefecture, Japan

Location

Oita Clinical Site

Yufu, Oita Prefecture, Japan

Location

Osaka Clinical Site

Habikino, Osaka, Japan

Location

Osaka Clinical Site

Hirakata, Osaka, Japan

Location

Osaka Clinical Site

Kishiwada, Osaka, Japan

Location

Osaka Clinical Site

Sakai, Osaka, Japan

Location

Osaka Clinical Site

Sayama, Osaka, Japan

Location

Osaka Clinical Site

Toyonaka, Osaka, Japan

Location

Osaka Clinical Site2

Osaka, Osaka Clinical Site, Japan

Location

Saga Clinical Site

Ureshino, Saga-ken, Japan

Location

Saitama Clinical Site

Hidaka, Saitama, Japan

Location

Saitama Clinical Site

Kitaadachi-gun, Saitama, Japan

Location

Shimane Clinical Site

Izumo, Shimane, Japan

Location

Shizuoka Clinical Site

Hamamatsu, Shizuoka, Japan

Location

Shizuoka Clinical Site

Sunto-gun, Shizuoka, Japan

Location

Tokyo Clinical Site2

Bunkyo-ku, Tokyo, Japan

Location

Tokyo Clinical Site

Bunkyo-ku, Tokyo, Japan

Location

Tokyo Clinical Site2

Bunkyō-Ku, Tokyo, Japan

Location

Tokyo Clinical Site2

Chuo-ku, Tokyo, Japan

Location

Tokyo Clinical Site

Chuo-ku, Tokyo, Japan

Location

Tokyo Clinical Site

Fuchū, Tokyo, Japan

Location

Tokyo Clinical Site

Itabashi-ku, Tokyo, Japan

Location

Tokyo Clinical Site

Kiyose, Tokyo, Japan

Location

Tokyo Clinical Site

Koto-ku, Tokyo, Japan

Location

Tokyo Clinical Site

Meguro City, Tokyo, Japan

Location

Tokyo Clinical Site

Minato-ku, Tokyo, Japan

Location

Tokyo Clinical Site

Mitaka-shi, Tokyo, Japan

Location

Tokyo Clinical Site

Shibuya City, Tokyo, Japan

Location

Tokyo Clinical Site2

Shinjuku-Ku, Tokyo, Japan

Location

Tokyo Clinical Site3

Shinjuku-Ku, Tokyo, Japan

Location

Tokyo Clinical Site

Shinjuku-ku, Tokyo, Japan

Location

Tokyo Clinical Site

Tachikawa, Tokyo, Japan

Location

Tottori Clinical Site

Yonago, Tottori, Japan

Location

Yamaguchi Clinical Site

Iwakuni, Yamaguchi, Japan

Location

Chiba Clinical Site2

Chiba, Japan

Location

Chiba Clinical Site

Chiba, Japan

Location

Fukui Clinical Site

Fukui, Japan

Location

Fukuoka Clinical Site2

Fukuoka, Japan

Location

Fukuoka Clinical Site3

Fukuoka, Japan

Location

Fukuoka Clinical Site4

Fukuoka, Japan

Location

Fukuoka Clinical Site

Fukuoka, Japan

Location

Gifu Clinical Site2

Gifu, Japan

Location

Gifu Clinical Site

Gifu, Japan

Location

Hiroshima Clinical Site2

Hiroshima, Japan

Location

Hiroshima Clinical Site

Hiroshima, Japan

Location

Kochi Clinical Site

Kochi, Japan

Location

Kumamoto Clinical Site

Kumamoto, Japan

Location

Kyoto Clinical Site

Kyoto, Japan

Location

Nagasaki Clinical Site

Nagasaki, Japan

Location

Niigata Clinical Site2

Niigata, Japan

Location

Niigata Clinical Site

Niigata, Japan

Location

Okayama Clinical Site2

Okayama, Japan

Location

Okayama Clinical Site

Okayama, Japan

Location

Osaka Clinical Site3

Osaka, Japan

Location

Osaka Clinical Site

Osaka, Japan

Location

Oita Clinical Site

Ōita, Japan

Location

Tokushima Clinical Site

Tokushima, Japan

Location

Toyama Clinical Site2

Toyama, Japan

Location

Toyama Clinical Site

Toyama, Japan

Location

Wakayama Clinical Site

Wakayama, Japan

Location

Yamaguchi Clinical Site

Yamaguchi, Japan

Location

Gangwon-Do Clinical Site

Wŏnju, Gangwon-do, South Korea

Location

Gyeonggi-do Clinical Site2

Seongnam-si, Gyeonggi-do, South Korea

Location

Gyeonggi-do Clinical Site

Seongnam-si, Gyeonggi-do, South Korea

Location

Gyeonggi-do Clinical Site

Suwon, Gyeonggi-do, South Korea

Location

Gyeongsangnam-do Clinical Site

Jinju, Gyeongsangnam-do, South Korea

Location

Chungcheongbuk-do Clinical Site

Cheongju-si, North Chungcheong, South Korea

Location

Busan Clinical Site

Busan, South Korea

Location

Daegu Clinical Site

Daegu, South Korea

Location

Incheon Clinical Site

Incheon, South Korea

Location

Seoul Clinical Site2

Seoul, South Korea

Location

Seoul Clinical Site3

Seoul, South Korea

Location

Seoul Clinical Site4

Seoul, South Korea

Location

Seoul Clinical Site5

Seoul, South Korea

Location

Seoul Clinical Site6

Seoul, South Korea

Location

Seoul Clinical Site

Seoul, South Korea

Location

Changhua Clinical Site

Changhua, Taiwan

Location

Chiayi Clinical Site

Chiayi City, Taiwan

Location

Kaohsiung Clinical Site2

Kaohsiung City, Taiwan

Location

Kaohsiung Clinical Site3

Kaohsiung City, Taiwan

Location

Kaohsiung Clinical Site

Kaohsiung City, Taiwan

Location

Taichung Clinical Site

Taichung, Taiwan

Location

Tainan Clinical Site

Tainan, Taiwan

Location

Taipei Clinical Site2

Taipei, Taiwan

Location

Taipei Clinical Site

Taipei, Taiwan

Location

Taoyuan Clinical Site

Taoyuan District, Taiwan

Location

Related Publications (3)

• Sugawara S, Lee JS, Kang JH, Kim HR, Inui N, Hida T, Lee KH, Yoshida T, Tanaka H, Yang CT, Inoue T, Nishio M, Goto Y, Tamura T, Yamamoto N, Yu CJ, Akamatsu H, Takahashi S, Nakagawa K. Plain language summary of TASUKI-52: A study looking at nivolumab plus platinum chemotherapy and bevacizumab as a combined treatment for people with advanced or recurrent nonsquamous non-small cell lung cancer (NSCLC). Future Oncol. 2026 Feb 4:1-13. doi: 10.1080/14796694.2026.2617855. Online ahead of print.

  PMID: 41640231 DERIVED

• Lee JS, Sugawara S, Kang JH, Kim HR, Inui N, Hida T, Lee KH, Yoshida T, Tanaka H, Yang CT, Inoue T, Nishio M, Goto Y, Tamura T, Yamamoto N, Yu CJ, Akamatsu H, Takahashi S, Nakagawa K. Four-Year Outcomes for Nivolumab With Chemotherapy and Bevacizumab in Patients With Nonsquamous NSCLC in the TASUKI-52. Cancer Sci. 2026 Jan 29. doi: 10.1111/cas.70330. Online ahead of print.

  PMID: 41611341 DERIVED

• Kim HR, Sugawara S, Lee JS, Kang JH, Inui N, Hida T, Lee KH, Yoshida T, Tanaka H, Yang CT, Nishio M, Ohe Y, Tamura T, Yamamoto N, Yu CJ, Akamatsu H, Takahashi S, Nakagawa K. First-line nivolumab, paclitaxel, carboplatin, and bevacizumab for advanced non-squamous non-small cell lung cancer: Updated survival analysis of the ONO-4538-52/TASUKI-52 randomized controlled trial. Cancer Med. 2023 Aug;12(16):17061-17067. doi: 10.1002/cam4.6348. Epub 2023 Aug 28.

  PMID: 37641544 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Carboplatin; Paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Medical Information Center
• Organization: Ono Pharmaceutical Co. Ltd

clinical_trial@ono.co.jp

---

Study Officials

• Shigeru Takahashi

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 17, 2017
• Study Start: June 13, 2017
• Primary Completion: February 10, 2020
• Study Completion: December 4, 2023
• Last Updated: May 6, 2024
• Results First Posted: April 26, 2022

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (10); JP (110); KR (15)