Evidence map›Paper›PMID 39985390›Full record

ArticleIntegrative cancer therapies

Efficacy and Safety of Herbal Medicine Bojungikki-Tang in Combination with Pembrolizumab versus Pembrolizumab Monotherapy for Stage IV Non-Small Cell Lung Cancer: Study Protocol for a Randomized, Open-Label, Double-Arm, Multicenter Trial.

Eunbyul Cho, Jin-Mu Yi, Jaemoo Chun, Ho Jang, Seong Hoon Yoon, Seung Hyeun Lee, Seung Hun Jang, Dong Won Park, Seung Joon Kim, Sang-Won Um and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Integrative cancer therapies. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
–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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
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

12 authors.

Eunbyul ChoKorea Institute of Oriental Medicine, Daejeon, Republic of Korea.ORCID 0000-0003-3431-1109
Jin-Mu YiKorea Institute of Oriental Medicine, Daejeon, Republic of Korea.ORCID 0000-0002-8717-3953
Jaemoo ChunKorea Institute of Oriental Medicine, Daejeon, Republic of Korea.ORCID 0000-0003-4191-4063
Ho JangKorea Institute of Oriental Medicine, Daejeon, Republic of Korea.ORCID 0000-0001-9869-4562
Seong Hoon YoonPusan National University, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.ORCID 0000-0002-2075-4702
Seung Hyeun LeeKyung Hee University, Seoul, Republic of Korea.ORCID 0000-0002-7666-313X
Seung Hun JangHallym University Sacred Heart Hospital, Anyang, Republic of Korea.ORCID 0000-0001-5457-5780
Dong Won ParkHanyang University College of Medicine, Seoul, Republic of Korea.
Seung Joon KimThe Catholic University of Korea, Seoul, Republic of Korea.ORCID 0000-0003-4836-8958
Sang-Won UmSungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Sung Yong LeeKorea University Guro Hospital, Seoul, Republic of Korea.
Mi-Kyung JeongKorea Institute of Oriental Medicine, Daejeon, Republic of Korea.ORCID 0000-0002-0239-0159

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNon-small cell lung cancer (NSCLC) exhibits low survival rates. Although immune checkpoint inhibitors (ICIs) have become first-line treatment for NSCLC, their limited response to ICI monotherapy has led to exploration of combination treatments. However, the high incidence of treatment-related adverse events associated with conventional drug combinations has highlighted the need for alternative herbal therapy. Bojungikki-tang (BJIKT), a traditional herbal medicine, has been used to treat gastrointestinal disorders and enhance immune function. Our preclinical studies have demonstrated that BJIKT combined with anti-PD-1 or anti-PD-L1 antibodies exhibits significant efficacy in suppressing tumor growth by modulating the immunosuppressive tumor microenvironment. Building on these preclinical findings, this study aims to evaluate the efficacy and safety of BJIKT with pembrolizumab combination therapy compared to pembrolizumab monotherapy in advanced NSCLC patients.

methods70 individuals with stage IV NSCLC scheduled for first-line pembrolizumab monotherapy will be randomly assigned to intervention or control groups. The primary outcome will be progression-free survival, with secondary outcomes including disease control rate, overall survival, and quality of life assessment. Adverse events will be monitored for safety. This study will explore the synergistic mechanism of combinatorial therapy using immune profiling and multi-omics analysis, and the possibility for personalized integrative therapy based on cold-heat syndrome differentiation (SD) types in East Asian medicine. DISCUSSION: This study will provide novel evidence regarding survival outcomes, quality of life, and safety profiles of combined ICI and BJIKT therapy for advanced NSCLC. The exploratory data will contribute to tailoring treatments to immune-based SD types in NSCLC patients.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDrugs, Chinese HerbalLung NeoplasmsAdultAgedFemaleHerbal MedicineHumansImmune Checkpoint InhibitorsMaleMiddle AgedMulticenter Studies as TopicNeoplasm StagingQuality of LifeAntibodies, Monoclonal, HumanizedDrugs, Chinese HerbalImmune Checkpoint InhibitorspembrolizumabBojungikki-tangnon-small cell lung cancerpembrolizumabprotocolrandomized controlled trial

Identifiers

PMID39985390
PMCPMC11847320

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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.