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Non-small Cell Lung CancerPhase 2NCT06249854

Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer

A Phase 2 study testing Bojungikki-tang(BJIKT) and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Korea Institute of Oriental Medicine at 7 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter, open-label, randomized controlled clinical trial designed to evaluate the efficacy and safety of combination therapy with Bojungikki-tang(BJIKT) and pembrolizumab monotherapy in patients with advanced non-small cell lung cancer whose tumors express PD-L1 positive with no EGFR or ALK genomic… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Bojungikki-tang(BJIKT) and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
7 sitesSouth Korea
Study dates
8 Feb 2024to 5 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who voluntarily decided to participate and provided written consent, after listening and understanding the detailed explanation about the clinical trial
  • Adult male or female aged 19 years or older
  • Patients with histologically or cytologically confirmed advanced (stage IV) non-small cell lung cancer [according to TNM 8th edition] In case of recurrence, only extra-thoracic metastasis is allowed.
  • Patients planned for immune checkpoint inhibitor (Pembrolizumab) monotherapy as first-line treatment (Patients with PD-L1 tumor proportion score(TPS) ≥ 50% and no EGFR or ALK genomic tumor aberrations)
  • Life expectancy ≥ 3 months
  • ECOG (Eastern Cooperative Oncology Group) Performance Status score of 0~2
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  • Patients with at least 1 measurable lesion as defined in RECIST V1.1
  • Patients with adequate bone marrow reserve or organ function as follows:
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,500/㎕
  • Platelet count ≥100× 10^3/㎕
  • Serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 45 ml/min (measured using standard methods at the study site)
  • ALT and AST ≤ 2.5× ULN Patients with liver metastasis: ALT and AST ≤ 5× ULN
  • Total bilirubin ≤ 1.5× ULN Patients with liver metastasis or known Gilbert syndrome(unconjugated hyperbilirubinemia): Total bilirubin ≤ 3× ULN

Who cannot join

  • Active brain metastases accompanied by clinically significant neurological symptoms or signs
  • Patients who diagnosed with another primary malignancy that affect non-small cell lung cancer in the last 5 years However, effectively treated non-melanoma skin cancer, carcinoma in situ of cervix, ductal carcinoma in situ of breast, thyroid cancer, or malignancies which were remained in remission during more than 3 years after being treated effectively and considered cured are permitted.
  • Patients who treated with immune checkpoint inhibitor or anti-CTLA-4 within the last 6 weeks or systemic immunosuppressive medications within the last 2 weeks However, low-dose corticosteroids (prednisone ≤ 10 mg/day or an equivalent dose of corticosteroid within 7 consecutive days) are permitted at the investigator's discretion.
  • Patients receiving thiazide or loop diuretics
  • Hypokalemia (less than 3.0 mEq/L)
  • Active interstitial lung disease requiring oral or intravenous steroid treatment
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  • Patients with autoimmune disease requiring systemic treatment at the time of enrollment
  • Uncontrolled diabetes mellitus at the time of enrollment (Uncontrolled with insulin and oral medications, HbA1c ≥ 8.0% or fasting blood sugar ≥ 200 mg/dL)
  • Patients with uncontrolled hypertension at the time of enrollment (systolic pressure \> 150 mmHg or diastolic pressure \>100 mmHg) despite use of antihypertensive agent
  • Patients with uncontrolled heart disease (severe heart failure, unstable angina, uncontrolled arrhythmia, or history of life-threatening arrhythmia, etc.)
  • Patients with hereditary problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
  • Patient with known active or uncontrolled HIV, tuberculosis, hepatitis B, or hepatitis C infection
  • Pregnant or lactating women
  • Patients who do not agree to use effective contraception during treatment period and for at least 5 months after the end of IP administration
  • Patients who received herbal medicine within 4 weeks before the first administration of IP (Bojungikgitang) and been decided that such intake affect the trial or safety of the subject at the investigator's discretion
  • Patients who received other investigational drugs within 30 days before the first administration of IP (Bojungikgitang)
  • Severe hypersensitivity to IP and its components (rash, redness, hives, eczema, dermatitis, itching, etc.)
  • Patients who are not eligible for the trial at the discretion of the investigator including severe infectious diseases or organ failure, etc.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Hallym University Medical Center

    Anyang-si, Gyeonggi-do, 14068

  • Kyung Hee University Hospital

    Seoul, 02447

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Samsung medical center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

  • The catholic university of Korea Seoul Saint. Mary's hospital

    Seoul

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

About this study

Official title: A Multicenter, Open Label, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer

This is a multicenter, open-label, randomized controlled clinical trial designed to evaluate the efficacy and safety of combination therapy with Bojungikki-tang(BJIKT) and pembrolizumab monotherapy in patients with advanced non-small cell lung cancer whose tumors express PD-L1 positive with no EGFR or ALK genomic tumor aberrations.

Based on prior pre-clinical studies, the combination of Bojungikki-tang and immune checkpoint inhibitors (ICIs) can be expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment.

Therefore, this clinical trial aims to assess the efficacy and safety of the combined therapy with BJIKT and pembrolizumab and establish clinical evidence for an integrative cancer treatment strategy by examining the survival rate and immune status following combined ICI and BJIKT treatment.

Read the detailed description

This is a multicenter, open-label, randomized controlled clinical trial to evaluate the efficacy and safety of combination therapy with Bojungikki-tang(BJIKT) and pembrolizumab monotherapy in patients with advanced non-small cell lung cancer whose tumors express PD-L1 positive with no EGFR or ALK genomic tumor aberrations. A total of 70 patients aged 19 or older will be enrolled in the study and progression-free survival (PFS) will be assessed as the primary endpoint.

In a pre-clinical study, the combination of immune checkpoint inhibitors(ICIs) and Bojungikki-tang extended the survival of mice compared to the administration of ICIs or BJIKT alone and reduced tumor volume and weight. In addition, it was confirmed that various immune-related factors in the tumor microenvironment were controlled to improve the immunosuppressed microenvironment and to strengthen the tumor immune response by increasing major immune cytokines in the blood. Furthermore, the combination of ICIs and BJIKT did not cause pharmacodynamic and pharmacokinetic drug interactions, and significant side effects of Bojungikki-tang were not observed in most clinical reports on long-term administration of Bojungikki-tang. Based on the results, the combination of BJIKT and ICIs is expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment.

In order to evaluate efficacy, variables including PFS, disease control rate (DCR), overall survival (OS), and quality of life will be used. The incidence rate of adverse events (AEs) and AEs with CTCAE grade 3 or higher will be assessed for safety. Most variables will be followed up during and after 45-week treatment, and the safety of interventions will be monitored consistently. Immune profiling and multi-omics analyses, including transcriptomic, proteomic, and metabolomic evaluations of PBMCs, will be conducted for exploratory purposes. In addition, pattern identification, a traditional diagnostic method in East Asian medicine, will be utilized as an exploratory variable. A validated questionnaire assessing Cold-Heat patterns, tongue diagnosis data, and pulse diagnosis data will be used to investigate their correlation with clinical and laboratory data.

Being tested
Bojungikki-tang(BJIKT), Pembrolizumab
Keywords
Bojungikki-tang, Buzhong Yiqi decoction, Hochu-ekki-to
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bojungikki-tang(BJIKT)Drug

    Also called Buzhong Yiqi Decoction, Hochu-ekki-to

    Bojungikgitang, which is a classical formulation widely used in South Korea, China, and Japan for a long time, has been reported to have following anticancer activities.

    1. Protective effect of intestine and hematopoietic organs against radiation damage
    2. Improving localized radiotherapy-induced immune deterioration
    3. Improving cancer-related fatigue and QOL
    4. Reducing radiation or chemotherapy induced side effects

  • PembrolizumabDrug

    It is a humanized antibody used in cancer immunotherapy for various types of cancer, including lung cancer. It targets the programmed cell death protein 1 (PD-1) receptor of lymphocytes. It was approved for medical use in the U.S. in 2014.

Study groups in NCT06249854
Study groupRoleWhat they receive
Bojungikkitang & Pembrolizumab combination treatment groupExperimentalPembrolizumab is administered intravenously every 3 weeks for 45 weeks according to standard procedures until disease progression (PD) or unacceptable toxicity occurs. Bojungikgitang is used in combination with immune checkpoint inhibitor treatment(Pembrolizumab) and is taken 1 bag twice a day before or between meals.
Receives: Drug: Bojungikki-tang(BJIKT); Drug: Pembrolizumab
Pembrolizumab monotherapy groupActive comparatorPembrolizumab is administered intravenously every 3-week for 45 weeks according to routine practice until disease progression (PD) or unacceptable toxicity occurs.
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    Measured: Every 9 weeks until PD(progressive disease), up to end of study (2 years from study initiation)

Secondary outcomes (12)

  1. Disease Control Rate (DCR)

    Measured: Every 9 weeks until PD(progressive disease), up to end of study (2 years from study initiation)

  2. Overall Survival (OS)

    Measured: Upon confirmation of death, end of the study (2 years from study initiation)

  3. Object Response Rate (ORR)

    Measured: Every 9 weeks until PD(progressive disease), up to end of study (2 years from study initiation)

  4. Time to Progression (TTP)

    Measured: Every 9 weeks until PD(progressive disease), up to end of study (2 years from study initiation)

  5. Duration of Response (DoR)

    Measured: End of study (2 years from study initiation)

  6. Time to Treatment Failure (TTF)

    Measured: Every 9 weeks until PD(progressive disease), up to end of study (2 years from study initiation)

  7. Number of participants with hyper-progressive disease

    Measured: Up to end of study (2 years from study initiation)

  8. Quality of Life (QoL)

    Measured: Baseline, Visit 4(week 10), End of Treatment(EOT) visit(week 46)

  9. Correlation between immuno/omics data and clinical data

    Measured: Baseline, week 4, week 10, week 19, week 28, week 37, End of Treatment(EOT) visit(week 46)

  10. Treatment response according to classification of the cold-heat pattern

    Cold-heat pattern classification (Cold pattern, Non-cold pattern, Heat pattern, Non-heat) refers to pattern identification of traditional East Asian medicine diagnosed by experts (Doctors of Korean Medicine) based on validated questionnaire, digital tongue diagnosis system data, and digital pulse diagnosis system data

    Measured: End of study (2 years from study initiation)

  11. Pulse waveform analysis of digital pulse diagnostic system

    The Electric Radial Tonometry device complies with ISO 18615:2020.

    Measured: Baseline, Visit 4(week 10), End of Treatment(EOT) visit(week 46)

  12. Data of digital tongue diagnosis system

    Categorical scales including tongue colors of tongue body: pale, light pink, red, and continuous variables including the Commission Internationale del'Éclairage (CIE) L*a*b* color values of tongue that represent the brightness, saturation of red and green, and saturation of blue and yellow, respectively.

    The equipment used in this study has an algorithm to increase repeatability and diagnostic accuracy by using indirect illumination and feedback gridlines. Also, it was designed to meet the international standards ISO 20498-1, 20498-2, 20498-3, 20498-4, and 20498-5.

    Measured: Baseline, Visit 4(week 10), End of Treatment(EOT) visit(week 46)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start8 Feb 2024
  3. Primary completion2 Dec 2025
  4. Study completion5 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06249854
Sponsor's protocol ID
KIOM-NSCLC-ICT-01
Status last verified
Aug 2026
First submitted
9 Jan 2024
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pai-Scherf L, Blumenthal GM, Li H, Subramaniam S, Mishra-Kalyani PS, He K, Zhao H, Yu J, Paciga M, Goldberg KB, McKee AE, Keegan P, Pazdur R. FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. Oncologist. 2017 Nov;22(11):1392-1399. doi: 10.1634/theoncologist.2017-0078. Epub 2017 Aug 23.

    PubMed 28835513

  • Postow MA, Sidlow R, Hellmann MD. Immune-Related Adverse Events Associated with Immune Checkpoint Blockade. N Engl J Med. 2018 Jan 11;378(2):158-168. doi: 10.1056/NEJMra1703481. No abstract available.

    PubMed 29320654

  • Sharma P, Hu-Lieskovan S, Wargo JA, Ribas A. Primary, Adaptive, and Acquired Resistance to Cancer Immunotherapy. Cell. 2017 Feb 9;168(4):707-723. doi: 10.1016/j.cell.2017.01.017.

    PubMed 28187290

  • Pishvar M, Amirkhosravi M, Altan MC. Magnet Assisted Composite Manufacturing: A Flexible New Technique for Achieving High Consolidation Pressure in Vacuum Bag/Lay-Up Processes. J Vis Exp. 2018 May 17;(135):57254. doi: 10.3791/57254.

    PubMed 29863655

  • Kimura M, Sasada T, Kanai M, Kawai Y, Yoshida Y, Hayashi E, Iwata S, Takabayashi A. Preventive effect of a traditional herbal medicine, Hochu-ekki-to, on immunosuppression induced by surgical stress. Surg Today. 2008;38(4):316-22. doi: 10.1007/s00595-007-3631-4. Epub 2008 Mar 27.

    PubMed 18368320

  • Peng M, Li X, Lei G, Weng YM, Hu MX, Song QB. The efficacy and safety of immune checkpoint inhibitor combination therapy in lung cancer: a systematic review and meta-analysis. Onco Targets Ther. 2018 Oct 24;11:7369-7383. doi: 10.2147/OTT.S177318. eCollection 2018.

    PubMed 30425525

  • Qi F, Zhao L, Zhou A, Zhang B, Li A, Wang Z, Han J. The advantages of using traditional Chinese medicine as an adjunctive therapy in the whole course of cancer treatment instead of only terminal stage of cancer. Biosci Trends. 2015 Feb;9(1):16-34. doi: 10.5582/bst.2015.01019.

    PubMed 25787906

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bojungikki-tang(BJIKT) and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Korea Institute of Oriental Medicine at 7 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Every 9 weeks until PD(progressive disease), up to end of study (2 years from study initiation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06249854, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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