Evidence map›Paper›PMID 40631772›Full record

Trial reportThe oncologist2025

First-line treatment with HDACis plus tislelizumab combined with chemotherapy in advanced NSCLC: a single-arm phase II study.

Lijie Wang, Ming Gao, Ting Wang, Pengfei Cui, Guangying Chen, Xiao Han, Zhiqiang Ma, Wenyu Yang, Fangfang Jing, Junxun Ma and 3 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Review
  2. Review
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

13 authors.

Lijie WangDepartment of Medical Oncology, Senior Department of Oncology, 5th Medical Centre of PLA General Hospital, Beijing 100071, China.
Ming GaoDepartment of Medical Oncology, Senior Department of Oncology, 5th Medical Centre of PLA General Hospital, Beijing 100071, China.ORCID 0000-0002-0215-8229
Ting WangMedical College of Nankai University, Department of Oncology, Tianjin 300071, China.
Pengfei CuiDepartment of Medical Oncology, 2nd Medical Centre of PLA General Hospital, Beijing 100036, China.
Guangying ChenDepartment of Medical Oncology, Senior Department of Oncology, 1st Medical Centre of PLA General Hospital, Beijing 100036, China.
Xiao HanDepartment of Medical Oncology, Senior Department of Oncology, 5th Medical Centre of PLA General Hospital, Beijing 100071, China.
Zhiqiang MaDepartment of Medical Oncology, Senior Department of Oncology, 5th Medical Centre of PLA General Hospital, Beijing 100071, China.
Wenyu YangMedical College of Nankai University, Department of Oncology, Tianjin 300071, China.
Fangfang JingDepartment of Medical Oncology, Senior Department of Oncology, 1st Medical Centre of PLA General Hospital, Beijing 100036, China.
Junxun MaDepartment of Medical Oncology, Senior Department of Oncology, 5th Medical Centre of PLA General Hospital, Beijing 100071, China.
Fan ZhangDepartment of Medical Oncology, Senior Department of Oncology, 5th Medical Centre of PLA General Hospital, Beijing 100071, China.
Haitao TaoDepartment of Medical Oncology, Senior Department of Oncology, 5th Medical Centre of PLA General Hospital, Beijing 100071, China.
Yi HuDepartment of Medical Oncology, Senior Department of Oncology, 5th Medical Centre of PLA General Hospital, Beijing 100071, China.ORCID 0000-0001-9319-5692

Funding

Beijing Cancer Prevention&Treatment Society and BeigeneBeijing Co., Ltd
6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors in combination with chemotherapy have been a common first-line treatment for non-small cell lung cancer (NSCLC), but they do not work for all patients. HDAC inhibitors (HDACis) may synergize with progressive disease (PD)-1 antibodies by inducing and activating cellular immunity. In this phase II study, we assessed the efficacy and tolerability of chidamide and tislelizumab in combination with chemotherapy in NSCLC patients.

methodsThis was a single-arm, prospective study. Driver-gene negative locally advanced and metastatic NSCLC patients without prior systemic treatment were enrolled. Patients received chidamide, tislelizumab, and chemotherapy for 4-6 cycles and were then maintained by tislelizumab and chidamide. The primary endpoint was objective response rate (ORR), and secondary endpoints included disease control rate (DCR), progression-free survival (PFS), duration of response, overall survival (OS) and safety.

resultsTwenty patients were enrolled in the study and most of them were PD-L1 1%-49% and PD-L1 < 1%. At the data cutoff, ORR was 80% (95% CI, 56.3-94.3), and DCR was 100%. The median follow-up was 23.4 months, the median PFS was 11.0 months (95% CI, 9.1-12.9m), and the median OS was 17.5 months (95% CI, 9.2-25.8m). Eleven patients (55.0%) had ≥ Grade 3 treatment-related adverse events (TRAEs). The most common ≥ Grade 3 TRAEs were leukopenia (25.0%) and neutropenia (20.0%). No patients died from treatment-related adverse events.

conclusionsThe combination of HDACi and tislelizumab with chemotherapy showed promising antitumor effects and manageable toxicity. More studies are needed to further confirm these results. CLINICALTRIALS.GOV IDENTIFIER: ChiCTR2000041542.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungHistone Deacetylase InhibitorsLung NeoplasmsAdultAgedAminopyridinesBenzamidesFemaleHumansMaleMiddle AgedProspective StudiesAminopyridinesAntibodies, Monoclonal, HumanizedBenzamidesHistone Deacetylase InhibitorsN-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamidetislelizumabchidamideefficacynon-small cell lung cancer (NSCLC)safetytislelizumab

Identifiers

PMID40631772
PMCPMC12238939

What OpenQuestion holds

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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.