AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3NCT03117049

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

A Phase 3 study testing ONO-4538, Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by Ono Pharmaceutical Co., Ltd. at 135 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
ONO-4538, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
550 participants
Where
135 sitesin 3 countries
Study dates
13 Jun 2017to 4 Dec 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

135 sites in 3 countries.

135 sites in 3 countries

Japan110 sites

  • Hyogo Clinical Site

    Akashi, Hyōgo

  • Hyogo Clinical Site

    Amagasaki, Hyōgo

  • Hokkaido Clinical Site

    Asahikawa, Hokkaido

  • Oita Clinical Site

    Beppu, Oita Prefecture

  • Tokyo Clinical Site2

    Bunkyo-ku, Tokyo

  • Tokyo Clinical Site

    Bunkyo-ku, Tokyo

  • Tokyo Clinical Site2

    Bunkyō-Ku, Tokyo

  • Chiba Clinical Site2

    Chiba

  • Chiba Clinical Site

    Chiba

  • Tokyo Clinical Site2

    Chuo-ku, Tokyo

  • Tokyo Clinical Site

    Chuo-ku, Tokyo

  • Tokyo Clinical Site

    Fuchū, Tokyo

  • Fukui Clinical Site

    Fukui

  • Fukuoka Clinical Site2

    Fukuoka

  • Fukuoka Clinical Site3

    Fukuoka

  • Fukuoka Clinical Site4

    Fukuoka

  • Fukuoka Clinical Site

    Fukuoka

  • Gifu Clinical Site2

    Gifu

  • Gifu Clinical Site

    Gifu

  • Osaka Clinical Site

    Habikino, Osaka

  • Shizuoka Clinical Site

    Hamamatsu, Shizuoka

  • Saitama Clinical Site

    Hidaka, Saitama

  • Ibaraki Clinical Site

    Higashiibaraki, Ibaraki

  • Hyogo Clinical Site

    Himeji, Hyōgo

  • Osaka Clinical Site

    Hirakata, Osaka

  • Aomori Clinical Site2

    Hirosaki, Aomori

  • Aomori Clinical Site

    Hirosaki, Aomori

  • Hiroshima Clinical Site2

    Hiroshima

  • Hiroshima Clinical Site

    Hiroshima

  • Fukuoka Clinical Site

    Iizuka, Fukuoka

  • Nara Clinical Site

    Ikoma, Nara

  • Kanagawa Clinical Site

    Isehara, Kanagawa

  • Hyogo Clinical Site

    Itami, Hyōgo

  • Yamaguchi Clinical Site

    Iwakuni, Yamaguchi

  • Shimane Clinical Site

    Izumo, Shimane

  • Kyoto Clinical Site

    Jōyō, Kyoto

  • Ishikawa Clinical Site2

    Kanazawa, Ishikawa-ken

  • Ishikawa Clinical Site3

    Kanazawa, Ishikawa-ken

  • Ishikawa Clinical Site

    Kanazawa, Ishikawa-ken

  • Ibaraki Clinical Site

    Kasama, Ibaraki

  • Kanagawa Clinical Site2

    Kawasaki, Kanagawa

  • Kanagawa Clinical Site

    Kawasaki, Kanagawa

  • Osaka Clinical Site

    Kishiwada, Osaka

  • Saitama Clinical Site

    Kitaadachi-gun, Saitama

  • Fukuoka Clinical Site

    Kitakyushu, Fukuoka

  • Tokyo Clinical Site

    Kiyose, Tokyo

  • Hyogo Clinical Site

    Kobe, Hyōgo

  • Kochi Clinical Site

    Kochi

  • Fukuoka Clinical Site

    Koga, Fukuoka

  • Fukushima Clinical Site

    Kōriyama, Fukushima

  • Kumamoto Clinical Site

    Kōshi, Kumamoto

  • Tokyo Clinical Site

    Koto-ku, Tokyo

  • Kumamoto Clinical Site

    Kumamoto

  • Fukuoka Clinical Site

    Kurume, Fukuoka

  • Kyoto Clinical Site

    Kyoto

  • Nagano Clinical Site

    Matsumoto, Nagano

  • Ehime Clinical Site

    Matsuyama, Ehime

  • Tokyo Clinical Site

    Meguro City, Tokyo

  • Tokyo Clinical Site

    Minato-ku, Tokyo

  • Tokyo Clinical Site

    Mitaka-shi, Tokyo

  • Iwate Clinical Site

    Morioka, Iwate

  • Niigata Clinical Site

    Nagaoka, Niigata

  • Nagasaki Clinical Site

    Nagasaki

  • Aichi Clinical Site2

    Nagoya, Aichi-ken

  • Aichi Clinical Site3

    Nagoya, Aichi-ken

  • Aichi Clinical Site4

    Nagoya, Aichi-ken

  • Aichi Clinical Site

    Nagoya, Aichi-ken

  • Miyagi Clinical Site

    Natori-shi, Miyagi

  • Niigata Clinical Site2

    Niigata

  • Niigata Clinical Site

    Niigata

  • Hyogo Clinical Site

    Nishinomiya, Hyōgo

  • Oita Clinical Site

    Ōita

  • Okayama Clinical Site2

    Okayama

  • Okayama Clinical Site

    Okayama

  • Nagasaki Clinical Site

    Ōmura, Nagasaki

  • Osaka Clinical Site2

    Osaka, Osaka Clinical Site

  • Osaka Clinical Site3

    Osaka

  • Osaka Clinical Site

    Osaka

  • Gunma Clinical Site

    Ōta, Gunma

  • Kanagawa Clinical Site

    Sagamihara, Kanagawa

  • Osaka Clinical Site

    Sakai, Osaka

  • Hokkaido Clinical Site2

    Sapporo, Hokkaido

  • Hokkaido Clinical Site

    Sapporo, Hokkaido

  • Osaka Clinical Site

    Sayama, Osaka

  • Miyagi Clinical Site

    Sendai, Miyagi

  • Gunma Clinical Site

    Shibukawa, Gunma

  • Tokyo Clinical Site

    Shibuya City, Tokyo

  • Tokyo Clinical Site

    Shinjuku-ku, Tokyo

  • Tokyo Clinical Site2

    Shinjuku-Ku, Tokyo

  • Tokyo Clinical Site3

    Shinjuku-Ku, Tokyo

  • Shizuoka Clinical Site

    Sunto-gun, Shizuoka

  • Tokyo Clinical Site

    tabashi City, Tokyo

  • Tokyo Clinical Site

    Tachikawa, Tokyo

  • Hyogo Clinical Site

    Takarazuka, Hyōgo

  • Tokushima Clinical Site

    Tokushima

  • Toyama Clinical Site2

    Toyama

  • Toyama Clinical Site

    Toyama

  • Aichi Clinical Site

    Toyoake, Aichi-ken

  • Osaka Clinical Site

    Toyonaka, Osaka

  • Mie Clinical Site

    Tsu, Mie-ken

  • Ibaraki Clinical Site

    Tsuchiura, Ibaraki

  • Saga Clinical Site

    Ureshino, Saga-ken

  • Wakayama Clinical Site

    Wakayama

  • Chiba Clinical Site

    Yachiyo, Chiba

  • Yamaguchi Clinical Site

    Yamaguchi

  • Kanagawa Clinical Site2

    Yokohama, Kanagawa

  • Kanagawa Clinical Site3

    Yokohama, Kanagawa

  • Kanagawa Clinical Site

    Yokohama, Kanagawa

  • Tottori Clinical Site

    Yonago, Tottori

  • Oita Clinical Site

    Yufu, Oita Prefecture

Other trials in Japan

South Korea15 sites

  • Busan Clinical Site

    Busan

  • Chungcheongbuk-do Clinical Site

    Cheongju-si, North Chungcheong

  • Daegu Clinical Site

    Daegu

  • Incheon Clinical Site

    Incheon

  • Gyeongsangnam-do Clinical Site

    Jinju, Gyeongsangnam-do

  • Gyeonggi-do Clinical Site2

    Seongnam-si, Gyeonggi-do

  • Gyeonggi-do Clinical Site

    Seongnam-si, Gyeonggi-do

  • Seoul Clinical Site2

    Seoul

  • Seoul Clinical Site3

    Seoul

  • Seoul Clinical Site4

    Seoul

  • Seoul Clinical Site5

    Seoul

  • Seoul Clinical Site6

    Seoul

  • Seoul Clinical Site

    Seoul

  • Gyeonggi-do Clinical Site

    Suwon, Gyeonggi-do

  • Gangwon-Do Clinical Site

    Wŏnju, Gangwon-do

Other trials in South Korea

Taiwan10 sites

  • Changhua Clinical Site

    Changhua

  • Chiayi Clinical Site

    Chiayi City

  • Kaohsiung Clinical Site2

    Kaohsiung City

  • Kaohsiung Clinical Site3

    Kaohsiung City

  • Kaohsiung Clinical Site

    Kaohsiung City

  • Taichung Clinical Site

    Taichung

  • Tainan Clinical Site

    Tainan

  • Taipei Clinical Site2

    Taipei

  • Taipei Clinical Site

    Taipei

  • Taoyuan Clinical Site

    Taoyuan

Other trials in Taiwan

About this study

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

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.

Being tested
ONO-4538, Carboplatin, Paclitaxel, Bevacizumab, Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONO-4538Drug

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

  • CarboplatinDrug

    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.

  • PaclitaxelDrug

    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.

  • BevacizumabDrug

    Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

  • PlaceboDrug

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

Study groups in NCT03117049
Study groupRoleWhat they receive
ONO-4538 groupExperimentalONO-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.
Receives: Drug: ONO-4538; Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab
Placebo groupPlacebo comparatorPlacebo: 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.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 32 months

Secondary outcomes (5)

  1. Overall Survival (OS)

    Measured: Approximately 32 months

  2. 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.

    Measured: Approximately 32 months

  3. 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.

    Measured: Approximately 32 months

  4. 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.

    Measured: Approximately 32 months

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

    Measured: Approximately 32 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2017
  2. Study start13 Jun 2017
  3. Primary completion10 Feb 2020
  4. Study completion4 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03117049
Sponsor's protocol ID
ONO-4538-52
Status last verified
May 2024
First submitted
12 Apr 2017
Last updated
6 May 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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;22(4):399-416. doi: 10.1080/14796694.2026.2617855. Epub 2026 Feb 4.

    PubMed 41640231

  • 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 Apr;117(4):1124-1135. doi: 10.1111/cas.70330. Epub 2026 Jan 29.

    PubMed 41611341

  • 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.

    PubMed 37641544

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ONO-4538, Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by Ono Pharmaceutical Co., Ltd. at 135 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC) (time frame: Approximately 32 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03117049, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in