Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
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.
Timeline
- Start
- 2017-06-13
- Primary completion
- 2020-02-10
- Completion
- 2023-12-04
Outcome
Met primary endpoint
registry MEDIAN ONO-4538 Group: 12.1 (9.8 to 14.0) months MEDIAN Placebo Group: 8.1 (7.0 to 8.5) months NCT03117049 ↗
registry analysis (superiority test); ONO-4538 Group vs Placebo Group; p <0.0001; Hazard Ratio (HR) 0.56 (96.37% CI 0.43 to 0.71); Stratified log-rank test NCT03117049 ↗
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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |