Early Stage Lung Cancer (I and II)Phase 2NCT04515004
Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer
A Phase 2 study testing leucoselect phytosome in people with Early Stage Lung Cancer (I and II), run by VA Office of Research and Development at 1 site in United States.
Trial summary
Lung cancer is the leading cause of cancer death in the country, surpassing deaths caused by colorectal, prostate and breast cancers combined. Veterans are at higher risk of lung cancer due to the higher rate of smoking and environmental toxin exposures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Early Stage Lung Cancer (I and II)
- What is being tested?
- leucoselect phytosome
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 31 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Initial screening:
- Lesions suspicious for lung cancer
- Competent to provide consent
- CBC within normal limits (WNL)
- liver function test WNL
- Normal Creatinine clearance as measured by the Cockcroft-Gault equation
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- ECOG Performance status: 0-1
- Enrollment for treatment with LP:
- Histologically proven and surgically resectable clinical I and II stage NSCLC
Who cannot join
- Inability to provide informed consent (e.g. cognitive impairment, severe psychiatric disorders)
- Hypersensitivity to grapes or related products
- Advance respiratory disease (Post resection FEV1 < 0.8 liters, resting hypoxemia, to ensure pts have adequate reserve to undergo diagnostic procedures and surgical resection)
- Unstable angina
- Other concurrent malignancy, excluding non-melanoma type skin cancer
- Have had a solid organ or bone marrow transplant
Show all 15Show fewer
- Pregnancy
- Breast feeding
- Systemic corticoid steroid therapy of > 10 mg prednisone equivalent daily
- Coagulopathy (PT-INR > 1.2, PTT > 40 seconds) or history of bleeding/clotting problems
- Concurrent use of Grapes or related products
- Unwilling to refrain from drinking more than 1 glass of wine a day
- Pts receiving medications known to be modulators of cytochrome P450 3A4 if alternative medication cannot be provided
- Currently taking other investigational agents
- Pts with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Lung cancer is the leading cause of cancer death in the country, surpassing deaths caused by colorectal, prostate and breast cancers combined. Veterans are at higher risk of lung cancer due to the higher rate of smoking and environmental toxin exposures. The lack of effective therapy for lung cancer provides the impetus to search for alternative, safe, and effective treatment agents to improve treatment strategy against lung cancer, enhance the probability of a cure and reduce recurrence. Based on encouraging preclinical and clinical findings from an early phase I lung cancer prevention study, using a special formulation of a standardized grape seed extract with enhanced absorption called leucoselect phytosome (LP), the purpose of this new CSR\&D Merit Review project is to evaluate the potential usefulness of LP for pre-surgical treatment of early stage lung cancer patients in a phase IIa clinical trial. Findings from this study may set the stage for larger, confirmatory trials in the near future.
Read the detailed description
The investigators will conduct a phase IIa, single arm study using 2-3 weeks of oral LP treatment for 30 early stage I and II lung cancer patients before surgical resection of their tumors.
Screening: Patients who have suspected early stage lung cancer will be recruited from Pulmonary and Thoracic Surgery clinics prior to diagnostic biopsy.
Following informed consent, which includes allowing the investigators to collect and store some of the samples from the clinical diagnostic procedures as pretreatment samples, such as bronchoscopy, needle aspirations, etc., subject will be screened with history and physical examination (H \& P), respiratory/general health questionnaires, food frequency self-assessment questionnaires, review of medical records, including radiographic imaging data, pulmonary function test (PFT), 12-lead EKG, clinical labs (complete blood chemistry panel, blood cell counts, PT, PTT). Most of these diagnostic tests will have already been obtained as a part of the clinical work up. However, new blood tests will be obtained if the last results were over 3 months ago). Blood samples and urine samples will be collected for research. Serum cotinine will be obtained to ascertain smoking status. A portion of the biospecimens (blood, urine, diagnostic samples) collected will be kept for future research at the NMVAHCS in an approved repository. A pregnancy test will be done for a woman who is able to have children.
Intervention: (treatment with study medication). If stage I or II lung cancer is diagnosed from standard clinical practice, the qualified subject will be enrolled into the intervention study to receive 2-3 weeks of LP, taken by mouth once a day, until the lung cancer surgery. At the time of surgery, serial clinical samples, including bronchoscopic and various surgically resected tissues, blood and urine will be collected as post-treatment samples. Pre- and post-treatment samples will be compared to assess how well oral LP has been absorbed, and whether or not there are encouraging anti-cancer changes occurring in the cells and molecules in response to the LP treatment. Once enrolled for intervention, all subjects will be monitored with weekly phone follow up, the safety of LP will be monitored weekly using standard reporting tools (including the NCI common terminology criteria for adverse events Version 5.0 and adverse reaction questionnaires), as well as pre-surgery H\&P and blood tests.
Follow up: Post-surgery phone follow up will occur at 3-4 weeks, 6 months and annually for up to 4 years.
- Conditions
- Early Stage Lung Cancer (I and II)
- Being tested
- leucoselect phytosome
- Keywords
- Grape seed procyanidin extract, Early stage lung cancer, Neoadjuvant treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leucoselect phytosomeDrug
A standardized grape seed procyanidin extract complexed with soy phospholipid.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All qualified participants meeting entry criteria that are enrolled will receive 2-3 weeks of oral LP treatment. Receives: Drug: leucoselect phytosome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in the Planned Surgery of >14 Days That is Possibly Related to Study Medication (Safety and Feasibility).
Defined as no delay in the planned surgery of >14 days that is possibly related to study medication.
Measured: No greater than 14 days delay in planned surgery.
Secondary outcomes (3)
Tumor Ki-67 Labeling Index (LI), a Marker of Cell Proliferation.
Modulations of tumor Ki-67 LI.
Measured: Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2
Histopathology: Pathological Response of Resected Tumor and Lymph Nodes.
Tumors and lymph nodes with no more than 10% viable tumor cells will be considered to have had a major pathological response.
Measured: Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2
Tumor Activated Caspase 3.
Modulations of this marker of apoptosis in tumors.
Measured: Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start20 Nov 2023
- Primary completion1 Nov 2024
- Study completion31 Mar 2025
Why it stopped: Early termination by sponsor due to substantial delays with subjects recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Early Stage Lung Cancer (I and II)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a phase IIa, single arm study using 2-3 weeks of oral LP treatment for stage I and II lung cancer patients before surgical resection of their tumors
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jenny T. Mao, MD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515004
- Sponsor's protocol ID
- ONCB-006-19F
- Other IDs
- I01CX002028
- Status last verified
- Jan 2026
- First submitted
- 10 Aug 2020
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT04515004
- Acronym / sponsor ID
- ONCB-006-19F
- Conditions
- Early Stage Lung Cancer (I and II)
- Keywords
- Grape seed procyanidin extract, Early stage lung cancer, Neoadjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination by sponsor due to substantial delays with subjects recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is the leading cause of cancer death in the country, surpassing deaths caused by colorectal, prostate and breast cancers combined. Veterans are at higher risk of lung cancer due to the higher rate of smoking and environmental toxin exposures. The lack of effective therapy for lung cancer provides the impetus to search for alternative, safe, and effective treatment agents to improve treatment strategy against lung cancer, enhance the probability of a cure and reduce recurrence. Based on encouraging preclinical and clinical findings from an early phase I lung cancer prevention study, using a special formulation of a standardized grape seed extract with enhanced absorption called leucoselect phytosome (LP), the purpose of this new CSR\&D Merit Review project is to evaluate the potential usefulness of LP for pre-surgical treatment of early stage lung cancer patients in a phase IIa clinical trial. Findings from this study may set the stage for larger, confirmatory trials in the near future.
Detailed description
The investigators will conduct a phase IIa, single arm study using 2-3 weeks of oral LP treatment for 30 early stage I and II lung cancer patients before surgical resection of their tumors.
Screening: Patients who have suspected early stage lung cancer will be recruited from Pulmonary and Thoracic Surgery clinics prior to diagnostic biopsy.
Following informed consent, which includes allowing the investigators to collect and store some of the samples from the clinical diagnostic procedures as pretreatment samples, such as bronchoscopy, needle aspirations, etc., subject will be screened with history and physical examination (H \& P), respiratory/general health questionnaires, food frequency self-assessment questionnaires, review of medical records, including radiographic imaging data, pulmonary function test (PFT), 12-lead EKG, clinical labs (complete blood chemistry panel, blood cell counts, PT, PTT). Most of these diagnostic tests will have already been obtained as a part of the clinical work up. However, new blood tests will be obtained if the last results were over 3 months ago). Blood samples and urine samples will be collected for research. Serum cotinine will be obtained to ascertain smoking status. A portion of the biospecimens (blood, urine, diagnostic samples) collected will be kept for future research at the NMVAHCS in an approved repository. A pregnancy test will be done for a woman who is able to have children.
Intervention: (treatment with study medication). If stage I or II lung cancer is diagnosed from standard clinical practice, the qualified subject will be enrolled into the intervention study to receive 2-3 weeks of LP, taken by mouth once a day, until the lung cancer surgery. At the time of surgery, serial clinical samples, including bronchoscopic and various surgically resected tissues, blood and urine will be collected as post-treatment samples. Pre- and post-treatment samples will be compared to assess how well oral LP has been absorbed, and whether or not there are encouraging anti-cancer changes occurring in the cells and molecules in response to the LP treatment. Once enrolled for intervention, all subjects will be monitored with weekly phone follow up, the safety of LP will be monitored weekly using standard reporting tools (including the NCI common terminology criteria for adverse events Version 5.0 and adverse reaction questionnaires), as well as pre-surgery H\&P and blood tests.
Follow up: Post-surgery phone follow up will occur at 3-4 weeks, 6 months and annually for up to 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase IIa, single arm study using 2-3 weeks of oral LP treatment for stage I and II lung cancer patients before surgical resection of their tumors
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: leucoselect phytosomeAll qualified participants meeting entry criteria that are enrolled will receive 2-3 weeks of oral LP treatment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Initial screening:
- Lesions suspicious for lung cancer
- Competent to provide consent
- CBC within normal limits (WNL)
- liver function test WNL
Key exclusion criteria (15 listed)
- Inability to provide informed consent (e.g. cognitive impairment, severe psychiatric disorders)
- Hypersensitivity to grapes or related products
- Advance respiratory disease (Post resection FEV1 < 0.8 liters, resting hypoxemia, to ensure pts have adequate reserve to undergo diagnostic procedures and surgical resection)
- Unstable angina
- Other concurrent malignancy, excluding non-melanoma type skin cancer
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 |
|---|---|---|
| leucoselect phytosomeA standardized grape seed procyanidin extract complexed with soy phospholipid. | Drug | Intervention |
Primary outcome
Delay in the Planned Surgery of >14 Days That is Possibly Related to Study Medication (Safety and Feasibility).
Time frame: No greater than 14 days delay in planned surgery.
Defined as no delay in the planned surgery of >14 days that is possibly related to study medication.
3 secondary outcomes
Tumor Ki-67 Labeling Index (LI), a Marker of Cell Proliferation.
Time frame: Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2
Histopathology: Pathological Response of Resected Tumor and Lymph Nodes.
Time frame: Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2
Tumor Activated Caspase 3.
Time frame: Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jenny T. Mao, MD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing leucoselect phytosome in people with Early Stage Lung Cancer (I and II), run by VA Office of Research and Development at 1 site in United States.
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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 17 Feb 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Delay in the Planned Surgery of >14 Days That is Possibly Related to Study Medication (Safety and Feasibility). (time frame: No greater than 14 days delay in planned surgery.). 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 17 Feb 2026.