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366 A randomized double-blind placebo-controlled phase III study evaluating perioperative toripalimab combined with platinum-based doublet chemotherapy in resectable stage III NSCLC
  1. Wenxiang Wang1,
  2. Lin Wu1,
  3. Wei Zhang2,
  4. Shun Lu3,
  5. Haohui Fang4,
  6. Guohua Yu5,
  7. Ming Zhou6,
  8. Wenqun Xing7,
  9. Qixun Chen8,
  10. Xingya Li9,
  11. Nong Yang1,
  12. Minhua Ye10,
  13. Wentao Fang3,
  14. Yunchao Huang11,
  15. Jichun Liu12,
  16. Lijie Tan13,
  17. Xiaosheng Hang14,
  18. Wengang Zhang15,
  19. Liwei Zhang16,
  20. Jun Chen17,
  21. Xun Zhang18,
  22. Yu Zhang19,
  23. Jie Jiang20,
  24. Aihong Zhong21,
  25. Shanqing Li22,
  26. Yunpeng Liu23,
  27. Guowu Wu24,
  28. Xiaoyan Kang25,
  29. Ying Tian25 and
  30. Tao Xu25
  1. 1Hunan cancer hospital, Changsha, China
  2. 2The First Affiliated Hospital Of Nanchang University, Nanchang, China
  3. 3Shanghai Chest Hospital Shanghai Jiaotong University, Shanghai, China
  4. 4Anhui Chest Hospital, Hefei, China
  5. 5Weifang People’s Hospital, Weifang, China
  6. 6Cancer Center of Guangzhou Medical University, Guangzhou, China
  7. 7Henan Cancer Hospital, Zhengzhou, China
  8. 8Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China
  9. 9The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
  10. 10Taizhou Hospital Of Zhejiang Province, Taizhou, China
  11. 11Yunnan Cancer Hospital, Kunming, China
  12. 12The Second Affiliated Hospital Of Nanchang University, Nanchang, China
  13. 13Zhongshan Hospital, Shanghai, China
  14. 14Affiliated Hospital Of Jiangnan University, Wuxi, China
  15. 15Tonghua Central Hospital, Tonghua, China
  16. 16The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China
  17. 17Tianjin Medical University General Hospital, Tianjin, China
  18. 18Tianjin Chest Hospital, Tianjin, China
  19. 19Nanjing Chest Hospital, Nanjing, China
  20. 20The First Affiliated Hospital Of Xiamen University, Xiamen, China
  21. 21Fuzhou Pulmonary Hospital Of Fujian, Fuzhou, China
  22. 22Peking Union Medical College Hospital, Peking, China
  23. 23The First Affiliated Hospital Of China Medical University, Shenyang, China
  24. 24Meizhou People’s Hospital, Meizhou, China
  25. 25Shanghai Junshi Biosciences Co., LTD, Shanghai, China


Background Surgery remains the mainstay of treatment for resectable stage III non-small cell lung cancer (NSCLC). The preliminary results from some pilot trials have shown that neoadjuvant immunotherapy in NSCLC is safe and tolerable.1 2Hypothesizing that neoadjuvant toripalimab (a humanized anti-PD-1 antibody) plus chemotherapy can improve the outcome in resectable NSCLC, we are conducting a randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of toripalimab plus platinum-based doublet chemotherapy as neoadjuvant/adjuvant therapy for patients with resectable stage III NSCLC.

Methods This ongoing study enrolls patients aged 18–70 years with treatment-naïve, histopathologically confirmed resectable stage III NSCLC without EGFR mutation or ALK translocation, ECOG PS 0–1, and adequate organ function. Eligible subjects are randomized (1:1) into experimental or control group, to receive perioperative toripalimab 240 mg or placebo combined with chemotherapy for 4 cycle in total (Docetaxel 60–75 mg/m2 or Paclitaxel 175 mg/m2 with platinum [squamous histology] or Pemetrexed 500 mg/m2 with platinum [non-squamous histology]) every 3 weeks for three cycles followed by surgery, and one more cycle after surgery, then monotherapy of toripalimab 240 mg or placebo every 3 weeks up to 13 cycles is delivered. Adjuvant radiotherapy is allowed. Randomization is stratified by tumor stage(IIIA vs IIIB), pathological type (squamous vs non-squamous), PD-L1 expression (PD-L1≥1% vs <1% or not evaluable) and planned surgical procedure (pneumonectomy vs lobectomy). Radiographic response is assessed within 4–6 weeks after last dose of neoadjuvant therapy, at 30 days after surgery and every 12 weeks thereafter. Primary endpoints are major pathologic response (MPR) rate evaluated by blind independent central pathology review (BIPR-MPR) and event-free survival evaluated by investigator (INV-EFS). Secondary endpoints include pathologic complete response (pCR) rate evaluated by BIPR and investigators (BIPR-pCR and INV-pCR), disease-free survival (DFS), 2–3 years OS rate, OS, safety, and feasibility of surgery. Exploratory endpoints are potential correlations between biomarkers and efficacy. A stratified Cochran Mantel Haenszel method will be used to assess binary endpoints. A Kaplan-Meier method, a stratified log-rank test and a stratified Cox proportional hazards model will be used to assess survival endpoints.Planned enrollment is 406 patients. The study is actively enrolling at 52 Chinese sites.

Results N/A

Conclusions N/A

Acknowledgements N/A

Trial Registration The Clinical trials. gov no NCT04158440

Ethics Approval This study was approved by the Ethics Board of all the involved sites; Approval number of Shanghai Chest Hospital: LS1936

Consent N/A


  1. Forde PM, Chaft JE, Smith KN, et al. Neoadjuvant PD-1 blockade in resectable lung cancer N Engl J Med 2018;378:1976–1986

  2. Hellmann MD, Chaft JE, William WN Jr, et al. Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint. Lancet oncol 2014;15:e42–50.

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