Evidence map›Paper›PMID 36581917›Full record

Trial reportBMC medicine2022

Safety and effectiveness of neoadjuvant PD-1 inhibitor (toripalimab) plus chemotherapy in stage II-III NSCLC (LungMate 002): an open-label, single-arm, phase 2 trial.

Xinsheng Zhu, Liangdong Sun, Nan Song, Wenxin He, Boxiong Xie, Junjie Hu, Jing Zhang, Jie Yang, Jie Dai, Dongliang Bian and 16 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 8 pooled it
9.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 8 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
    Guideline
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  14. Redefining breast cancer: therapeutic opportunities in HER2-low and emerging molecular subtypes.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
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  18. Cardiovascular Pharmacotherapy and Glucose Metabolism: The Good, the Bad and the Unsightly.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
    Review
  19. Revisiting nature of stage III non-small cell lung cancer: Anatomically defined, biologically systemic.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 2 institutions in 1 country.

Xinsheng Zhu *Department of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Liangdong Sun *Department of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Nan Song *Department of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Wenxin He *Department of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Boxiong Xie *Department of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Junjie HuDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Jing ZhangDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Jie YangDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Jie DaiDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Dongliang BianDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Haoran XiaDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Fenghuan SunDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Anwen XiongDepartment of Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Jie LuoDepartment of Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Lele ZhangCentral Laboratory, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Huansha YuDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Ming LiuDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Hongcheng LiuDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Haifeng WangDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Haiping ZhangDepartment of Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Chang ChenDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Chunyan WuDepartment of Pathology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Liang DuanDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China. duan-liang@163.com.
Yuming ZhuDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China. zhuyuming@tongji.edu.cn.
Peng ZhangDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China. zhangpeng1121@tongji.edu.cn.
Gening JiangDepartment of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, 200092, China. geningjiang@tongji.edu.cn.
Tongji University · CNShanghai Pulmonary Hospital · CN

Funding

Shanghai Hospital Development Center SHDC2020CR2020BShanghai Pulmonary Hospital FKCX1904, FKLY20004
6 · The paper itself

Abstract

backgroundThis trial aimed to analyse the safety, effectiveness and transcriptomic characteristics of neoadjuvant toripalimab plus chemotherapy in II-III non-small-cell lung cancer (NSCLC).

methodsPatient eligibility mainly involved treatment-naive, clinical stage II-III and wild-type EGFR/ALK NSCLC. The patients received 2-4 cycles of toripalimab (240 mg q3w) plus carboplatin-based chemotherapy. After the second treatment cycle, all patients were re-evaluated by a multidisciplinary team. Candidates eligible for surgery underwent surgery; otherwise, patients received the remaining treatment cycles. The primary endpoints were safety and major pathological response (MPR). Secondary endpoints were R0 resection rate, progression-free survival (PFS) and overall survival (OS). RNA sequencing of baseline and post-treatment samples was conducted to explore the transcriptomic characteristics of the therapeutic response.

resultsIn total, 50 eligible patients were enrolled, including 12 (24.0%) with resectable disease (RD) and 38 (76.0%) with potentially resectable disease (PRD). Treatment-related adverse events (TRAEs) were recorded in 48 cases (96.0%). Severe TRAEs occurred in 3 (6.0%) cases, including myelosuppression, drug-induced liver injury and death related to haemoptysis. The objective response rate (ORR) was 76.0%, with 8 (16.0%) patients having a complete response (CR), 30 (60.0%) partial response (PR), 10 (20.0%) stable disease (SD) and 2 (4.0%) progressive disease (PD). Surgery could be achieved in 12 (100%) patients with RD and 25 (65.8%) with PRD; 1 (2.0%) with PRD refused surgery. Therefore, R0 resection was performed for all 36 (100%) patients who underwent surgery; 20 (55.6%) achieved MPR, including 10 (27.8%) with a complete pathological response (pCR). The CHI3L1 (chitinase-3-like protein 1) immunohistochemistry (IHC) expression of baseline tumour samples could predict the therapeutic response (AUC=0.732), OS (P=0.017) and PFS (P=0.001). Increased PD-1 expression, T cell abundance and immune-related pathway enrichment were observed in post-treatment samples compared to baseline in the response group (CR+PR) but not in the non-response group (SD+PD).

conclusionsNeoadjuvant toripalimab plus chemotherapy was safe and effective, with a high MPR and manageable TRAEs for II-III NSCLC, even converting initially PRD to RD. Disparate transcriptomic characteristics of therapeutic efficiency were observed, and CHI3L1 expression predicted therapeutic response and survival.

trial registrationChiCTR1900024014, June 22, 2019.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, Monoclonal, HumanizedHumansImmune Checkpoint InhibitorsNeoadjuvant TherapyAntibodies, Monoclonal, HumanizedImmune Checkpoint InhibitorstoripalimabNeoadjuvant chemoimmunotherapyNon-small-cell lung cancerPotentially resectable diseaseTranscriptomic characteristics

Identifiers

PMID36581917
PMCPMC9801594
OpenAlexW4313332037

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.