Trial Outcomes & Findings for Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer (NCT NCT04515004)
NCT ID: NCT04515004
Last Updated: 2026-02-17
Results Overview
Defined as no delay in the planned surgery of \>14 days that is possibly related to study medication.
TERMINATED
PHASE2
6 participants
No greater than 14 days delay in planned surgery.
2026-02-17
Participant Flow
Substantial delays in startup and recruitment resulted from the COVID-19 pandemic, PI station transfer, retesting of study drug and local installation of IP equipment need for lung cancer diagnosis (completed in June 2024). By 9/2024 and following completion of the informed consent process for 6 subjects, only 2 subjects qualified for enrollment, however CSR\&D terminated the study before the intervention - recruitment goals would not be reached within the originally approved study timeline.
Participant milestones
| Measure |
Intervention
To determine the feasibility of LP as a neoadjuvant agent against early stage lung cancer via a single arm, phase IIa study using LP in 30 patients with newly diagnosed, stage I and II resectable lung cancer.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer
Baseline characteristics by cohort
| Measure |
Intervention
n=6 Participants
To determine the feasibility of LP as a neoadjuvant agent against early stage lung cancer via a single arm, phase IIa study using LP in 30 patients with newly diagnosed, stage I and II resectable lung cancer.
|
|---|---|
|
Age, Customized
Age range: 66-79
|
6 participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: No greater than 14 days delay in planned surgery.Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Defined as no delay in the planned surgery of \>14 days that is possibly related to study medication.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of tumor Ki-67 LI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Tumors and lymph nodes with no more than 10% viable tumor cells will be considered to have had a major pathological response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this marker of apoptosis in tumors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulation of COX-2 expression in Tumor.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this marker of inflammation and immunity in biospecimens.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this marker of inflammation and immunity in biospecimens.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this marker of inflammation and immunity in biospecimens.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this marker of inflammation and immunity in biospecimens.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this oncogenic miRNA in serum and tumors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this marker of cancerization.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this oncogenic miRNA in serum and tumors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this marker of cancerization.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this oncogenic miRNA in serum and tumors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Change of lung cancer stage based on the American Joint Committee on Cancer (AJCC) TNM staging system.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Population: Data were not collected due to the early termination - no participants received the intervention and data will not be collected in the future.
Modulations of this marker of inflammation and immunity in biospecimens.
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place