Bomedemstat and Maintenance Immunotherapy for Treatment of Newly Diagnosed Extensive Stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT05191797|
Recruitment Status : Recruiting
First Posted : January 14, 2022
Last Update Posted : June 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Extensive Stage Lung Small Cell Carcinoma Limited Stage Lung Small Cell Carcinoma||Drug: Bomedemstat Biological: Atezolizumab||Phase 1 Phase 2|
Patients receive bomedemstat orally (PO) once daily (QD) on days 1-21 and atezolizumab intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Bomedemstat Combined With Maintenance Immunotherapy for Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC)|
|Actual Study Start Date :||April 11, 2022|
|Estimated Primary Completion Date :||January 15, 2025|
|Estimated Study Completion Date :||January 15, 2026|
Experimental: Treatment (bomedemstat, atezolizumab)
Patients receive bomedemstat PO QD on days 1-21 and atezolizumab IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Incidence of dose limiting toxicity (DLT) [ Time Frame: Up to 21 days from initiation of treatment ]
DLT to bomedemstat combined with atezolizumab is defined as the occurrence of any of the following toxicities by CTCAE 5.03 determined to be possibly, probably, or likely related to bomedemstat or atezolizumab occurring within 21 days of initiation of treatment. The specific events are:
- Grade 4 non-hematologic toxicity (not laboratory).
- Grade 3 non-hematologic toxicity (not laboratory) lasting >3 days despite optimal supportive care.
Any Grade 3 or Grade 4 non-hematologic laboratory value if:
- Medical intervention is required to treat the patient, or
- The abnormality leads to hospitalization
- Thrombocytopenia leading to clinically significant sequelae (i.e., a clinically significant bleeding event or the need for prophylactic transfusions).
- Febrile neutropenia.
- Grade 5 toxicity.
- Progression free survival [ Time Frame: From the date of registration to the date of first document of progressive disease or symptomatic deterioration (as defined above), or death due to any cause, assessed at 6 months ]Distributions for time-to-event outcomes will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function.
- Incidence of adverse events [ Time Frame: Up to 30 days after discontinuation of study treatment ]
Only adverse events that meet the following definition will be recorded:
- All grade 3 and higher adverse events
- Grade 1-2 adverse events that require medical intervention, i.e. initiation of a new medication, or are otherwise clinically significant at the discretion of the investigator
- Any adverse event that requires a dose reduction or dose delay of either bomedemstat or atezolizumab Adverse events will be recorded from Cycle 1 Day 1 until the Safety Monitoring visit performed according to the Study Calendar (Section 7.0), using the Adverse Event case report forms/worksheets. For subjects who discontinue study therapy for a reason other than disease progression and are being followed with Monitoring visits (Section 188.8.131.52), adverse events should continue to be monitored. Adverse events related to either bomedemstat or atezolizumab will be followed until resolution or stabilization of the AE or until the beginning of a new anti-neoplastic therapy, whichever occurs first.
- Overall survival [ Time Frame: From the date of registration until death from any cause, assessed at 6 months ]Distributions for time-to-event outcomes will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191797
|Contact: Rebecca Woodemail@example.com|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Rebecca Wood 206-606-6970 firstname.lastname@example.org|
|Principal Investigator: Rafael Santana-Davila|
|Principal Investigator:||Rafael Santana-Davila||Fred Hutch/University of Washington Cancer Consortium|