Trial Outcomes & Findings for Bomedemstat and Maintenance Immunotherapy for Treatment of Newly Diagnosed Extensive Stage Small Cell Lung Cancer (NCT NCT05191797)

NCT ID: NCT05191797

Last Updated: 2024-09-26

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Up to 21 days from initiation of treatment

Results posted on

2024-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	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. Bomedemstat: Given PO Atezolizumab: Given IV
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bomedemstat and Maintenance Immunotherapy for Treatment of Newly Diagnosed Extensive Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Bomedemstat, Atezolizumab) n=3 Participants 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. Bomedemstat: Given PO Atezolizumab: Given IV
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age, Continuous	63 Years n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	3 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 21 days from initiation of treatment

Outcome measures

Outcome measures
Measure	Treatment (Bomedemstat, Atezolizumab) n=3 Participants 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. Bomedemstat: Given PO Atezolizumab: Given IV
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)	0 Participants

PRIMARY outcome

Timeframe: From the date of study enrollment up to 2 years

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.

Outcome measures

Outcome measures
Measure	Treatment (Bomedemstat, Atezolizumab) n=3 Participants 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. Bomedemstat: Given PO Atezolizumab: Given IV
Progression Free Survival	3.82 months Interval 1.53 to 6.11

PRIMARY outcome

Timeframe: From initial of treatment, up to 30 days after discontinuation of study treatment, up to 7 months

Only adverse events that meet the following definition will be recorded: 1. All grade 3 and higher adverse events 2. 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 3. 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 8.5.3.3), 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.

Outcome measures

Outcome measures
Measure	Treatment (Bomedemstat, Atezolizumab) n=3 Participants 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. Bomedemstat: Given PO Atezolizumab: Given IV
Incidence Patients Experiencing Adverse Events Shingles	1 Participants
Incidence Patients Experiencing Adverse Events Syncope	1 Participants
Incidence Patients Experiencing Adverse Events H. Pylori	1 Participants
Incidence Patients Experiencing Adverse Events Fatigue	1 Participants
Incidence Patients Experiencing Adverse Events Maculopapular Rash	1 Participants
Incidence Patients Experiencing Adverse Events Left Lower Extremity Pain	1 Participants
Incidence Patients Experiencing Adverse Events Left Lower Extremity Weaskness	1 Participants
Incidence Patients Experiencing Adverse Events Elevated Creatinine	1 Participants
Incidence Patients Experiencing Adverse Events Transaminitis	1 Participants

SECONDARY outcome

Timeframe: From the date of study enrollment until death from any cause up to 2 years

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.

Outcome measures

Outcome measures
Measure	Treatment (Bomedemstat, Atezolizumab) n=3 Participants 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. Bomedemstat: Given PO Atezolizumab: Given IV
Overall Survival	15.1 Months Interval 6.56 to 23.64

Adverse Events

Treatment (Bomedemstat, Atezolizumab)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Bomedemstat, Atezolizumab) n=3 participants at risk 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. Bomedemstat: Given PO Atezolizumab: Given IV
Investigations Elevated Creatinine	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months 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 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 30 days post EOT.
Investigations Transaminitis	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months 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 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 30 days post EOT.
Nervous system disorders Syncope	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months 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 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 30 days post EOT.
Gastrointestinal disorders H. Pylori	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months 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 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 30 days post EOT.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months 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 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 30 days post EOT.
Infections and infestations Shingles	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months 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 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 30 days post EOT.
Skin and subcutaneous tissue disorders Maculopapular Rash	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months 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 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 30 days post EOT.
Musculoskeletal and connective tissue disorders Left Lower Extremity Pain	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months 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 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 30 days post EOT.
Musculoskeletal and connective tissue disorders Left Lower Extremity Weakness	33.3% 1/3 • Number of events 1 • All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months 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 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 30 days post EOT.

Additional Information

Rafael Santana-Davila

University of Washington

Phone: 2066062190

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place