PMID- 34992825
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220429
IS  - 2072-1439 (Print)
IS  - 2077-6624 (Electronic)
IS  - 2072-1439 (Linking)
VI  - 13
IP  - 11
DP  - 2021 Nov
TI  - Neoadjuvant camrelizumab, nab-paclitaxel, and carboplatin in patients with stage 
      IB-IIIA non-small cell lung cancer (NANE-LC): a study protocol of prospective, 
      single-arm, multicenter, phase II study.
PG  - 6468-6475
LID - 10.21037/jtd-21-1022 [doi]
AB  - BACKGROUND: Previous studies have shown that neoadjuvant immune checkpoint 
      inhibitors (ICIs) combined with chemotherapy in patients with stage IB-IIIA 
      non-small cell lung cancer (NSCLC) significantly improved the major pathological 
      response (MPR) and the pathological complete response (pCR) rates. However, 
      high-level evidence-based medical data confirming this effect are still lacking. 
      In addition, there is an urgent need to develop an appropriate strategy to 
      predict the benefit for patients receiving ICIs. In this study, we describe an 
      ongoing study on the effect of neoadjuvant therapy with camrelizumab, 
      nab-paclitaxel, and carboplatin on stage IB-IIIA NSCLC patients. The aim of this 
      study is to establish a multiomics artificial intelligence system for predicting 
      neoadjuvant therapy efficacy and assisting decision-making. METHODS: This 
      prospective, single-arm, multicenter, phase II trial will enroll a total of 40 
      patients who will undergo surgery after three cycles of neoadjuvant therapy with 
      camrelizumab, nab-paclitaxel, and carboplatin. The MPR rate is the primary 
      endpoint, while the rates of pCR, complete resection, objective response, 
      disease-free survival (DFS), adverse events (AEs), and quality of life (QOL) are 
      secondary endpoints. Exploratory endpoints will serve to establish a multiomics 
      artificial intelligence system for neoadjuvant therapy effect prediction and 
      decision-making assistance based on radiomics, metabolism, genetic, and 
      clinic-pathological characteristics and to explore the mechanisms of drug 
      resistance. DISCUSSION: The efficacy of ICIs is influenced by many factors, 
      including patient's driver genes and smoking status. Thus, further subgroup 
      analysis is needed. This study will indicate if our new multiomics artificial 
      intelligence system constitutes a valid strategy for neoadjuvant therapy effect 
      prediction and decision-making assistance in the context of neoadjuvant 
      camrelizumab, nab-paclitaxel, and carboplatin treatment for patients with stage 
      IB-IIIA NSCLC. TRIAL REGISTRATION: This trial has been registered at 
      ClinicalTrials.gov (identification number: NCT04541251).
CI  - 2021 Journal of Thoracic Disease. All rights reserved.
FAU - Zhou, Haiyu
AU  - Zhou H
AD  - Division of Thoracic Surgery, Guangdong Provincial People's Hospital & Guangdong 
      Academy of Medical Sciences, School of Medicine, South China University of 
      Technology, Guangzhou, China.
AD  - Division of Thoracic Surgery, Jiangxi Lung Cancer Institute, Jiangxi Provincial 
      Cancer Hospital, Nanchang, China.
FAU - Lin, Lili
AU  - Lin L
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
FAU - Qin, Tao
AU  - Qin T
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
FAU - Ren, Wei
AU  - Ren W
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
FAU - Tan, Yujie
AU  - Tan Y
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
FAU - Yang, Qiong
AU  - Yang Q
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
FAU - Xu, Huixin
AU  - Xu H
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
FAU - Xie, Xinxin
AU  - Xie X
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
FAU - Chen, Yongjian
AU  - Chen Y
AD  - Department of Medical Oncology, Third Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, China.
FAU - Liu, Shengbo
AU  - Liu S
AD  - Division of Thoracic Surgery, Guangdong Provincial People's Hospital & Guangdong 
      Academy of Medical Sciences, School of Medicine, South China University of 
      Technology, Guangzhou, China.
FAU - Li, Xing
AU  - Li X
AD  - Department of Medical Oncology, Third Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, China.
FAU - Li, Zhihua
AU  - Li Z
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
FAU - Hu, Hai
AU  - Hu H
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
FAU - Yu, Yunfang
AU  - Yu Y
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
AD  - AI & Digital Media Concentration Program, Division of Science and Technology, 
      Beijing Normal University-Hong Kong Baptist University United International 
      College, Zhuhai, China.
FAU - Yao, Herui
AU  - Yao H
AD  - Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene 
      Regulation, Department of Medical Oncology, Phase I Clinical Trial Centre, Sun 
      Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT04541251
PT  - Journal Article
PL  - China
TA  - J Thorac Dis
JT  - Journal of thoracic disease
JID - 101533916
PMC - PMC8662502
OTO - NOTNLM
OT  - Neoadjuvant therapy
OT  - artificial intelligence
OT  - checkpoint inhibitors
OT  - immune
OT  - major pathological response
OT  - non-small cell lung cancer (NSCLC)
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at https://dx.doi.org/10.21037/jtd-21-1022). The authors have no 
      conflicts of interest to declare.
EDAT- 2022/01/08 06:00
MHDA- 2022/01/08 06:01
PMCR- 2021/11/01
CRDT- 2022/01/07 06:25
PHST- 2021/06/22 00:00 [received]
PHST- 2021/09/29 00:00 [accepted]
PHST- 2022/01/07 06:25 [entrez]
PHST- 2022/01/08 06:00 [pubmed]
PHST- 2022/01/08 06:01 [medline]
PHST- 2021/11/01 00:00 [pmc-release]
AID - jtd-13-11-6468 [pii]
AID - 10.21037/jtd-21-1022 [doi]
PST - ppublish
SO  - J Thorac Dis. 2021 Nov;13(11):6468-6475. doi: 10.21037/jtd-21-1022.