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Clinical Trial
. 2025 Aug:206:108633.
doi: 10.1016/j.lungcan.2025.108633. Epub 2025 Jun 23.

Phase III study of ramucirumab plus docetaxel versus atezolizumab for previously treated PD-L1 low or negative advanced non-small-cell lung cancer: WJOG10317L study

Yoshitaka Zenke  1 , Seiji Niho  2 , Yukihiro Toi  3 , Masafumi Yamaguchi  4 , Satoshi Hara  5 , Yuki Akazawa  6 , Yukio Hosomi  7 , Kimio Yonesaka  8 , Hiroaki Akamatsu  9 , Toshihide Yokoyama  10 , Junko Tanizaki  11 , Kiyonobu Ueno  12 , Hiroshi Gyotoku  13 , Toshihiro Misumi  14 , Kazuhiko Nakagawa  8 , Nobuyuki Yamamoto  9 , Masahiro Tsuboi  15
Affiliations
Clinical Trial

Phase III study of ramucirumab plus docetaxel versus atezolizumab for previously treated PD-L1 low or negative advanced non-small-cell lung cancer: WJOG10317L study

Yoshitaka Zenke et al. Lung Cancer. 2025 Aug.

Abstract

Purpose: We aimed to compare the efficacy and safety of docetaxel plus ramucirumab and atezolizumab as second-line treatment for programmed death-ligand 1 (PD-L1)-negative or low advanced non-small-cell-lung cancer (NSCLC) after platinum-based chemotherapy.

Patients and methods: This multicenter randomized phase III study enrolled patients with advanced NSCLC who had progressed during or after first-line platinum-based chemotherapy. Patients were allocated randomly (1:1) to receive atezolizumab (arm A) or docetaxel plus ramucirumab (arm B) every 3 weeks. The primary endpoint was overall survival (OS).

Results: This study was activated in April 2018 and closed in March 2020 due to slow accrual. Seventy eligible patients were enrolled from 26 institutions, including 36 patients in arm A and 34 in arm B. The median OS (median follow-up, 24.2 months) were 17.1 and 15.8 months (HR = 1.508, 95 % confidence interval (CI), 0.86-2.65; P = 0.23), respectively. The 2-year OS rates were 42.8 % (95 % CI, 26.2 %-58.4 %) and 19.4 % (95 %CI, 7.5-35.3), the objective response rates (ORRs) were 5.6 % and 35.3 % (P = 0.002), and the median progression-free survival (PFS) were 1.5 and 5.5 months (P = 0.005), respectively. The crossover rates were 55.6 % and 64.7 %, and the median times from randomization to progression or death post-crossover were 12.9 and 9.1 months. Grade ≥ 3 toxicities included neutropenia (2.8 %/17.6 %), thrombocytopenia (2.8 %/8.8 %), anorexia (2.8 %/5.9 %), febrile neutropenia (0 %/5.9 %), and hypertension (2.8 %/8.8 %).

Conclusions: OS was similar in both arms, but docetaxel plus ramucirumab resulted in favorable ORR and PFS. The 2-year OS rates suggested that atezolizumab might enhance the efficacy of post-study cytotoxic chemotherapy; however, interpretation of the data was limited by the small sample size.

Keywords: Atezolizumab; Docetaxel plus ramucirumab; Non-small-cell-lung cancer; Programmed death-ligand 1; Second-line treatment.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Y. Zenke reports personal fees from Taiho Pharmaceutical Co., Chugai Pharmaceutical Co., AstraZeneca, Pfizer, MSD, Novartis, Daiichi Sankyo Pharmaceutical Co., Eli Lilly, Boehringer Ingelheim, Kyowa Kirin Pharmaceutical Co. Takeda Pharmaceutical Co, Ono Pharmaceutical Co. Ltd, and Bristol Myers Squibb, Gurdant health, Nippon Kayaku, Amgen as well as grants from AstraZeneca, Merck, GlaxoSmithKline, Amgen, Gilead Sicences. outside the submitted work. S. Niho reports personal fees from Chugai, Eli Lilly, Taiho, Boehringer Ingelheim, Shionogi, Kyowa Kirin, Teijin, GlaxoSmithKline, Daiichi Sankyo. Ono. Kyorin as well as personal fees from AstraZeneca, Chugai, Eli Lilly, Daiichi Sankyo, MSD. Ono. Takeda. Eisai. Pfizer. Kyorin. Taiho, Nippon Kayaku. Novartis. Amgen. Boehringer Ingelheim. Merck.Kyowa Kirin outside the submitted work. Y. Toi reports personal fees from Ono Pharmaceutical, MSD, Astrazeneca, TAIHO PHARMACEUTICAL CO.,Bristol-Myers Squibb, Chugai Pharmaceutical Co. outside the submitted work. Y. Hosomi reports personal fees from AstraZeneca, Eli Lilly Japan, Taiho Pharmaceutical, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol-Myers Squibb, Kyowa Kirin, Nippon Kayaku, Takeda, Eisai, Novartis, Pfizer outside the submitted work. K. Yonesaka reports personal fees from Chugai Pharmaceutical Co. Ltd. MSD Co. Ltd. outside the submitted work. H. Akamatsu reports personal fees from AstraZeneca K.K., Boehringer Ingelheim Japan Inc., Bristol Myers Squibb Co. Ltd., Novartis Pharma K.K., Taiho Pharmaceutical Co. Ltd., and Ono Pharmaceutical Co. Ltd., as well as grants and personal fees from Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., and MSD K.K. outside the submitted work. T. Yokoyama reports grants from AbbVie GK, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Delta-Fly Pharma, Janssen, MSD, Parexel International, Takeda as well as personal fees from AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, Merck Biopharma, MSD, Nippon Kayaku, Novartis, Ono Pharmaceutical, Pfizer, Takeda outside the submitted work.J. Tanizaki reports personal fees from Boehringer-Ingelheim Japan Inc, Bristol-Myers Squibb Co. Ltd, Chugai Pharmaceutical Co., Ltd, Daiichi sankyo Co., Ltd, Eli Lilly Japan K.K, Janssen Pharmaceutical K.K, MSD K.K, Nihon Medi-Physics Co.,Ltd, Nippon Kayaku Co.,Ltd, Taiho Pharmaceutical Co. Ltd. K, Ono pharmaceutical Co. Ltd, Pfizer Japan Inc, AstraZeneca K.K. Takeda Pharmaceuticals outside the submitted work. T. Misumi reports personal fees from Chugai AstraZeneca Miyarisan outside the submitted work. . Nakagawa also reports personal fees from CMIC Co. Ltd., Care Net Inc., Medical Review Co. Ltd., Medical Mobile Communications Co. Ltd, 3H Clinical Trial Inc., YODOSHA Co. Ltd., Nikkei Business Publications Inc., TAIYO Pharma Co. Ltd., Nippon Kayaku Co. Ltd., CMIC Shift Zero K.K., Kyowa Kirin Co. Ltd., Life Technologies Japan Ltd., Neo Communication, and Roche Diagnostics K.K.; personal fees and other support from KYORIN Pharmaceutical Co. Ltd.; grants and personal fees from Takeda Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., AbbVie Inc., Bayer Yakuhin Ltd., Japan Clinical Research Operations, and Amgen Inc.; grants from Parexel International Corp., Kissei Pharmaceutical Co. Ltd., EPS Corporation, Syneos Health Clinical K.K., Pfizer R&D Japan G.K., A2 Healthcare Corp., IQVIA Services Japan K.K., Eisai Co. Ltd., EPS International Co. Ltd., Otsuka Pharmaceutical Co. Ltd., PRA Health Sciences, Covance Japan Inc., Medical Research Support, Sanofi K.K., PPD-SNBL K.K, Sysmex Corporation, Mochida Pharmaceutical Co. Ltd., GlaxoSmithKline K.K., SymBio Pharmaceuticals Ltd., Mebix Inc., Janssen Pharmaceutical K.K., and SRL Inc. outside the submitted work. In addition, K. Nakagawa has a patent for Daiichi Sankyo Co. Ltd. issued. N. Yamamoto reports grants and personal fees from AstraZeneca K.K., Boehringer Ingelheim Japan Inc., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co. Ltd., Pfizer Japan Inc., Takeda Pharmaceutical, and Taiho Pharmaceutical Co. Ltd.; N. Yamamoto also reports personal fees from Novartis Pharma K.K., as well as grants from Astellas Pharma Inc., A2 Healthcare Corporation, Bristol Myers Squibb Co. Ltd., CMIC Shift Zero K.K., Daiichi Sankyo Co. Ltd., IQVIA Services Japan K.K., and PPD-SNBL K.K. outside the submitted work. K. Nakagawa reports grants and personal fees from AstraZeneca K.K., MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., Bristol Myers Squibb Company, and Chugai Pharmaceutical Co. Ltd.; grants, personal fees, and other support from Ono Pharmaceutical Co. Ltd., Pfizer Japan Inc., and Eli Lilly Japan K.K.; grants from Daiichi Sankyo Co. Ltd.; and personal fees from Merck Biopharma Co. Ltd. outside the submitted work. M. Tsuboi reports grants from MSD AstraZeneca KK Bristol-Myers Squibb KK Ono Pharmaceutical CO, LTD Eli Lilly Japan Novartis MiRXES Johnson & Johnson Japan as well as personal fees from Johnson & Johnson Japan Medtronic Japan AstraZeneca KK, Eli Lilly Japan Chugai Pharmaceutical CO.,LTD, Taiho Pharma, Bristol-Myers Squibb KK, Ono Pharmaceutical CO.,LTD, Novalis, MSD, Daiichi-Sankyo, Amgen KK outside the submitted work. No disclosures were reported by the other authors.

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