Trial Outcomes & Findings for Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma (NCT NCT04452292)
NCT ID: NCT04452292
Last Updated: 2023-05-17
Results Overview
Percentage of patients able to be sequenced within 2 months of the initial medical oncology visit.
COMPLETED
NA
2 participants
2 months
2023-05-17
Participant Flow
Opened to accrual in 11/2020 was closed to enrollment on 11/2022 due to poor accrual. Target accrual was 15 participants.
Participant milestones
| Measure |
No TP53/Rb1 Co-Mutation
HG-LCNEC tumor lacking the TP53/Rb1 co-mutation (non-small cell-like).
Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma: Treatment assigned to targetable mutation. Or, for tumors that are by and large without any targetable mutation follow Large-Cell Neuroendocrine Carcinoma (NCCN) guideline-directed best front-line treatment for specific non-small cell carcinoma/adenocarcinoma.
|
TP53/Rb1 Co-Mutation Present
HG-LCNEC tumor with the TP53/Rb1 co-mutation.
Treatment for Small Cell Lung Cancer: Treatment assigned to a targetable mutation or the current standard-of-care regimen for the treatment of small cell lung cancer.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Next Generation Sequencing-Based Stratification of Front Line Treatment of HighGrade Neuroendocrine Carcinoma
Baseline characteristics by cohort
| Measure |
No TP53/Rb1 Co-Mutation
n=2 Participants
HG-LCNEC tumor lacking the TP53/Rb1 co-mutation (non-small cell-like).
Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma: Treatment assigned to targetable mutation. Or, for tumors that are by and large without any targetable mutation follow Large-Cell Neuroendocrine Carcinoma (NCCN) guideline-directed best front-line treatment for specific non-small cell carcinoma/adenocarcinoma.
|
TP53/Rb1 Co-Mutation Present
HG-LCNEC tumor with the TP53/Rb1 co-mutation.
Treatment for Small Cell Lung Cancer: Treatment assigned to a targetable mutation or the current standard-of-care regimen for the treatment of small cell lung cancer.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
—
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Percentage of patients able to be sequenced within 2 months of the initial medical oncology visit.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 monthsPopulation: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Percentage of patients who were successfully assigned into a molecularly-defined cohort (TP53/RB1 co-mutations or not).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Duration of time from the first cycle of anticancer therapy to time of progressive disease or death from any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Percentage of patients experiencing overall complete response (CR).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Percentage of patients experiencing overall partial response (PR).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Percentage of patients experiencing overall progressive disease (PD).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Percentage of patients experiencing overall stable disease (SD).
Outcome measures
Outcome data not reported
Adverse Events
No TP53/Rb1 Co-Mutation
TP53/Rb1 Co-Mutation Present
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