Trial Outcomes & Findings for Liver Directed RT + Chemo-immunotherapy for ES-SCLC (NCT NCT04923776)
NCT ID: NCT04923776
Last Updated: 2024-12-30
Results Overview
Progression free survival rate at 6 months will be measured to assess the efficacy of liver-directed SBRT when added to standard of care atezolizumab + chemotherapy. 6-month PFS rate will be defined as the proportion of patients that are progression free and alive at 6 months from the start of treatment.
TERMINATED
PHASE2
2 participants
Up to 6 months
2024-12-30
Participant Flow
Two individuals signed a consent form. Of the two, one participant was a screen failure and did not initiate treatment.
Participant milestones
| Measure |
Experimental: Chemotherapy+SBRT
Addition of SBRT, directed at liver metastases, to standard of care (SOC) treatment atezolizumab+chemotherapy in SCLC. All patients must undergo a mandatory biopsy of a liver lesion prior to chemotherapy initiation.
Cycle 1 of chemoimmunotherapy will be administered as per standard of care, with radiation planning to be done subsequently in anticipation of liver-directed SBRT.
Carboplatin: The dosage for this drug is area under the curve (AUC) 5 mg/ml/min intravenous, Day 1, every 21 days for 4 cycles. This is standard of care.
Etoposide: The dosage for this drug is 100 mg/m2 Intravenous, Days 1-3, every 21 days for 4 cycles. This is standard of care.
Atezolizumab: The dosage for this drug is 1200 mg Intravenous, Day 1, every 21 days until disease progression. This is standard of care.
Stereotactic Body Radiation Therapy (SBRT): This radiotherapy is given within +/-3 days of cycle 2, 10 Gy 3 doses on alternating days. This is not standard of care and considered interventional.
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liver Directed RT + Chemo-immunotherapy for ES-SCLC
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Data was not analyzed or disclosed in an effort to protect participant confidentiality (n=1).
Progression free survival rate at 6 months will be measured to assess the efficacy of liver-directed SBRT when added to standard of care atezolizumab + chemotherapy. 6-month PFS rate will be defined as the proportion of patients that are progression free and alive at 6 months from the start of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data was not analyzed or disclosed in an effort to protect participant confidentiality (n=1).
Overall survival (OS) will be defined as the time from treatment start to date of death or last follow up. Patients lost to follow-up at the cut-off date will be censored in the analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data was not analyzed or disclosed in an effort to protect participant confidentiality (n=1).
Disease control rate (DCR) will be defined as the proportion of patients who have a partial (PR) or complete response (CR) or stable disease (SD) after beginning study treatment. Only patients who have received at least one cycle of therapy and have had their disease re-evaluated will be considered evaluable for response.
Outcome measures
Outcome data not reported
Adverse Events
Experimental: Chemotherapy+SBRT
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