A Phase 1/2 interventional study of Bomedemstat and Atezolizumab in Extensive Stage Lung Small Cell Carcinoma and Limited Stage Lung Small Cell Carcinoma, sponsored by University of Washington. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by University of Washington · Phase 1/2, Interventional, and Treatment
This phase I/II trial studies the side effects of bomedemstat and maintenance immunotherapy with atezolizumab and to see how well they work in treating patients with newly diagnosed extensive stage small cell lung cancer. Bomedemstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving bomedemstat and atezolizumab may work better in treating patients with extensive stage small cell lung cancer.
OUTLINE:
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.
University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Histologically confirmed diagnosis of extensive stage small-cell lung cancer (ES-SCLC)
Having received four cycles of platinum-etoposide concurrent with three or four cycles of immune checkpoint inhibitor as induction systemic therapy for ES-SCLC immediately prior to study enrollment (see below for definitions). Note that immune checkpoint inhibitor may have been omitted from the first cycle only
Minimum life expectancy of >= 12 weeks
International normalized ratio (INR) \< 1.5 x upper limit of normal (only in patients not receiving anticoagulant agents at baseline)
Activated partial thromboplastin time (aPTT) \< 1.5 x the local upper limit of normal (only in patients not receiving anticoagulant agents at baseline)
Exclusion Criteria:
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion:
Active autoimmune disease requiring systemic immunosuppression or history of autoimmune disease requiring systemic immunosuppression within the last 2 years
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.
Drug: Bomedemstat · Biological: Atezolizumab
Given PO
Also known as: 1990504-34-1, IMG 7289, IMG-7289, LSD-1 Inhibitor IMG-7289, Lysine-specific Demethylase 1 Inhibitor IMG-7289
Given IV
Also known as: 1380723-44-3, Immunoglobulin G1, Anti-(human CD Antigen cd274) (Human Monoclonal MPDL3280A Heavy Chain), Disulfide with Human Monoclonal MPDL3280A Kappa-chain, Dimer, MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
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.
Time frame: Up to 21 days from initiation of treatment
Progression Free Survival
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.
Time frame: From the date of study enrollment up to 2 years
Incidence Patients Experiencing Adverse Events
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.
Time frame: From initial of treatment, up to 30 days after discontinuation of study treatment, up to 7 months
Overall Survival
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.
Time frame: From the date of study enrollment until death from any cause up to 2 years
| Milestone | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
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.
| Participants | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| Number of Participants Experiencing a Dose Limiting Toxicity (DLT) | 0 |
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.
| months | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| Progression Free Survival | 3.82 (1.53 to 6.11) |
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.
| Participants | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| Elevated Creatinine | 1 |
| Transaminitis | 1 |
| Syncope | 1 |
| H. Pylori | 1 |
| Fatigue | 1 |
| Shingles | 1 |
| Maculopapular Rash | 1 |
| Left Lower Extremity Pain | 1 |
| Left Lower Extremity Weaskness | 1 |
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.
| Months | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| Overall Survival | 15.1 (6.56 to 23.64) |
Collected over All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Bomedemstat, Atezolizumab) | 3/3 (100%) | 0/3 (0%) | 3/3 (100%) |
| Event | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| Elevated CreatinineInvestigations | 1/3 |
| TransaminitisInvestigations | 1/3 |
| SyncopeNervous system disorders | 1/3 |
| H. PyloriGastrointestinal disorders | 1/3 |
| FatigueGeneral disorders | 1/3 |
| ShinglesInfections and infestations | 1/3 |
| Maculopapular RashSkin and subcutaneous tissue disorders | 1/3 |
| Left Lower Extremity PainMusculoskeletal and connective tissue disorders | 1/3 |
| Left Lower Extremity WeaknessMusculoskeletal and connective tissue disorders | 1/3 |
| Age, Categorical(Participants) | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 1 |
| Age, Continuous(Years) | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| Median | 63 (58 to 67) |
| Sex: Female, Male(Participants) | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| Female | 2 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Bomedemstat, Atezolizumab) |
|---|---|
| United States | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Bomedemstat