Non Small Cell Lung CancerNCT04348149
Lindera Obtusiloba for Non-small Cell Lung Cancer
A study testing Lindera obtusiloba extract in people with Non Small Cell Lung Cancer, run by Jun-Yong Choi at 1 site in South Korea.
Trial summary
This randomized, open labelled, non-treatment-controlled study evaluates the safety and efficacy of Lindera obtusiloba, a dietary food, on quality of life of non-small cell lung cancer patients who are receiving PD-1 or PD-L1 inhibitors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Lindera obtusiloba extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Dec 2018to 27 Dec 2020
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 20 years
- Patients who have understood and signed the informed consent.
- Subjects who have been confirmed histologically and radiologically for non small cell lung cancer and are scheduled to receive treatment with immune checkpoint inhibitors
- Subjects whose urine HCG are negative and who have agreed with the appropriate method of contraception in case of women of childbearing potential
- Subjects who can fully communicate with their medical doctor about their symptoms or quality of life and who can fill out questionnaires
- Subjects who can follow up during the clinical trial
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
- Hemoglobin ≥ 9g/dL
Who cannot join
- Subjects who are pregnant, breastfeeding, planning to become pregnant or women of childbearing potential who do not agree with the appropriate method of contraception
- Subjects who have symptomatic and uncontrolled brain or central nervous system metastasis
- Subjects who complain of uncontrolled pain despite using analgesics
- Diastolic Blood Pressure>100mmHg or Systolic Blood Pressure>160mmHg
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels higher than 2.5 times the upper limit for normal
- Creatinine level higher than 1.5 times the upper limit for normal
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- Subjects who have participated in other clinical trials within 1 months
- Subjects with a history of serious drug allergies or who have hypersensitivity to the Investigational Product (the main ingredient and its components)
- Subjects with autoimmune diseases
- Subjects who have alcoholism or drug dependence
- Subjects who have cognitive impairment or psychiatric problems
- Subjects who have undergone surgery within 2 weeks
- Subjects who took other herbal medicine or other medicines within 4 weeks
- Subjects who have a medical condition that is likely to affect results or who are determined to be inappropriate to participate in this clinical trial at the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korean Medicine Hospital, Pusan National University
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: Adjunctive Administration of Lindera Obtusiloba on Non-small Cell Lung Cancer Patients Who Receive PD-1 Inhibitors: a Randomized Exploratory Pilot Study
This randomized, open labelled, non-treatment-controlled study evaluates the safety and efficacy of Lindera obtusiloba, a dietary food, on quality of life of non-small cell lung cancer patients who are receiving PD-1 or PD-L1 inhibitors.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Lindera obtusiloba extract
- 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.
Lindera obtusiloba extractDietary supplement
One package of dietary supplement contains one gram of 70% ethanol extracted powder of Lindera obtusiloba and one gram of glucose powder. Participants intake one package per day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Dietary Supplement: Lindera obtusiloba extract |
| Wait-list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-C30
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is a 30-item patient-reported questionnaire comprising five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality-of-life scale, and six single-item symptom measures. Each scale or item score is linearly transformed to a range from 0 to 100 (minimum: 0; maximum: 100). Higher scores on the functional scales and the global health status/quality-of-life scale indicate better functioning or quality of life, whereas higher scores on the symptom scales and single-item symptom measures indicate greater symptom severity and therefore a worse outcome. Changes from baseline will be assessed at Weeks 6 and 8.
Measured: Change from baseline to 6-week and 8-week
EORTC QLQ-LC13
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) is a 13-item lung cancer-specific patient-reported questionnaire used in conjunction with the EORTC QLQ-C30. It assesses lung cancer-related symptoms and treatment-related problems, including dyspnoea, coughing, haemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, and pain at specific sites. Scores for the dyspnoea scale and individual symptom items are linearly transformed to a range from 0 to 100 (minimum: 0; maximum: 100). Higher scores indicate greater symptom severity or treatment-related problems and therefore a worse outcome. Changes from baseline will be assessed at Weeks 6 and 8.
Measured: Change from baseline to 6-week and 8-week
Secondary outcomes (3)
NK cell percentage in peripheral blood
Measured: Change from baseline to 8-week
CD4+/CD8+ T cell in peripheral blood
Measured: Change from baseline to 8-week
total T cell, T-helper cell, T-suppressor cell and B-cell percentage in peripheral blood
Measured: Change from baseline to 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start28 Dec 2018
- Primary completion27 Dec 2020
- Study completion27 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun-Yong Choi
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Responsible party
- Sponsor-investigator, Jun-Yong Choi, Korean Medicine Hospital of Pusan National University
- Investigators
- Jun-Yong Choi, KMD/PHD, Principal investigator, Korean Medicine Hospital of Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348149
- Sponsor's protocol ID
- PNUKHIRB-2018012
- Status last verified
- Aug 2026
- First submitted
- 10 Apr 2020
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Administration of Lindera Obtusiloba on Non-small Cell Lung Cancer Patients Who Receive PD-1 Inhibitors: a Randomized Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT04348149
- Acronym / sponsor ID
- PNUKHIRB-2018012
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jun-Yong ChoiUniversity, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 27 Dec 2020 (actual)
- Study completion
- 27 Dec 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, open labelled, non-treatment-controlled study evaluates the safety and efficacy of Lindera obtusiloba, a dietary food, on quality of life of non-small cell lung cancer patients who are receiving PD-1 or PD-L1 inhibitors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Lindera obtusiloba extract |
| Wait-list | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged ≥ 20 years
- Patients who have understood and signed the informed consent.
- Subjects who have been confirmed histologically and radiologically for non small cell lung cancer and are scheduled to receive treatment with immune checkpoint inhibitors
- Subjects whose urine HCG are negative and who have agreed with the appropriate method of contraception in case of women of childbearing potential
- Subjects who can fully communicate with their medical doctor about their symptoms or quality of life and who can fill out questionnaires
Key exclusion criteria (14 listed)
- Subjects who are pregnant, breastfeeding, planning to become pregnant or women of childbearing potential who do not agree with the appropriate method of contraception
- Subjects who have symptomatic and uncontrolled brain or central nervous system metastasis
- Subjects who complain of uncontrolled pain despite using analgesics
- Diastolic Blood Pressure>100mmHg or Systolic Blood Pressure>160mmHg
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels higher than 2.5 times the upper limit for normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lindera obtusiloba extractOne package of dietary supplement contains one gram of 70% ethanol extracted powder of Lindera obtusiloba and one gram of glucose powder. Participants intake one package per day for 8 weeks. | Dietary supplement | Intervention group |
Primary outcome
EORTC QLQ-C30
Time frame: Change from baseline to 6-week and 8-week
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is a 30-item patient-reported questionnaire comprising five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality-of-life scale, and six single-item symptom measures. Each scale or item score is linearly transformed to a range from 0 to 100 (minimum: 0; maximum: 100). Higher scores on the functional scales and the global health status/quality-of-life scale indicate better functioning or quality of life, whereas higher scores on the symptom scales and single-item symptom measures indicate greater symptom severity and therefore a worse outcome. Changes from baseline will be assessed at Weeks 6 and 8.
EORTC QLQ-LC13
Time frame: Change from baseline to 6-week and 8-week
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) is a 13-item lung cancer-specific patient-reported questionnaire used in conjunction with the EORTC QLQ-C30. It assesses lung cancer-related symptoms and treatment-related problems, including dyspnoea, coughing, haemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, and pain at specific sites. Scores for the dyspnoea scale and individual symptom items are linearly transformed to a range from 0 to 100 (minimum: 0; maximum: 100). Higher scores indicate greater symptom severity or treatment-related problems and therefore a worse outcome. Changes from baseline will be assessed at Weeks 6 and 8.
3 secondary outcomes
NK cell percentage in peripheral blood
Time frame: Change from baseline to 8-week
CD4+/CD8+ T cell in peripheral blood
Time frame: Change from baseline to 8-week
total T cell, T-helper cell, T-suppressor cell and B-cell percentage in peripheral blood
Time frame: Change from baseline to 8-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun-Yong Choi, KMD/PHD principal investigator
Korean Medicine Hospital of Pusan National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lindera obtusiloba extract in people with Non Small Cell Lung Cancer, run by Jun-Yong Choi at 1 site 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 8 inclusion and 14 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 12 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 1 site 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.
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?
EORTC QLQ-C30 (time frame: Change from baseline to 6-week and 8-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.