NCT05191797

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

Terminated Phase 1, PHASE2 Results posted Last updated 26 September 2024

What this trial tests

Phase 1, PHASE2 trial testing Bomedemstat in Extensive Stage Lung Small Cell Carcinoma in 3 participants. Terminated before completion.

Timeline

11 April 2022

Primary endpoint
3 August 2023

5 April 2024

Quick facts

Lead sponsor	University of Washington
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	11 April 2022
Primary completion	3 August 2023
Estimated completion	5 April 2024
Sites	1 location across United States

Drugs / interventions tested

• Bomedemstat — full drug profile →
• Atezolizumab (atezolizumab) — full drug profile →

Conditions studied

• Extensive Stage Lung Small Cell Carcinoma — all drugs for Extensive Stage Lung Small Cell Carcinoma →
• Limited Stage Lung Small Cell Carcinoma — all drugs for Limited Stage Lung Small Cell Carcinoma →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Extensive Stage Lung Small Cell Carcinoma or Limited Stage Lung Small Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Primary · 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

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	0

Progression Free Survival Primary · 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.

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	3.82	1.53 – 6.11

Incidence Patients Experiencing Adverse Events Primary · 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 sub

Elevated Creatinine

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	1

Transaminitis

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	1

Syncope

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	1

H. Pylori

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	1

Fatigue

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	1

Shingles

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	1

Maculopapular Rash

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	1

Left Lower Extremity Pain

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	1

Overall Survival Secondary · 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.

Group	Value	95% CI
Treatment (Bomedemstat, Atezolizumab)	15.1	6.56 – 23.64

Adverse events — posted to ClinicalTrials.gov

Time frame: All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 1 year, 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Bomedemstat, Atezolizumab)

Serious: 0/3 (0%)

Deaths: 3/3

Other adverse events (9 terms — click to expand)

Reaction	System	Treatment (Bomedemstat, At…
Elevated Creatinine	Investigations	—
Transaminitis	Investigations	—
Syncope	Nervous system disorders	—
H. Pylori	Gastrointestinal disorders	—
Fatigue	General disorders	—
Shingles	Infections and infestations	—
Maculopapular Rash	Skin and subcutaneous tissue disorders	—
Left Lower Extremity Pain	Musculoskeletal and connective tissue disorders	—
Left Lower Extremity Weakness	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT05191797 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
   Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
2. Epigenetic regulation in the tumor microenvironment: molecular mechanisms and therapeutic targets.
   Yang J, Xu J, Wang W, Zhang B, et al · · 2023 · cited 251× · PMID 37217462 · DOI 10.1038/s41392-023-01480-x
3. Targeting epigenetic regulators to overcome drug resistance in cancers.
   Wang N, Ma T, Yu B, Yu B. · · 2023 · cited 213× · PMID 36797239 · DOI 10.1038/s41392-023-01341-7
4. Epigenetics-targeted drugs: current paradigms and future challenges.
   Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
5. Inhibition of LSD1 with Bomedemstat Sensitizes Small Cell Lung Cancer to Immune Checkpoint Blockade and T-Cell Killing.
   Hiatt JB, Sandborg H, Garrison SM, Arnold HU, et al · · 2022 · cited 101× · PMID 35920742 · DOI 10.1158/1078-0432.ccr-22-1128
6. Methylation across the central dogma in health and diseases: new therapeutic strategies.
   Liu R, Zhao E, Yu H, Yuan C, et al · · 2023 · cited 79× · PMID 37620312 · DOI 10.1038/s41392-023-01528-y
7. LSD1 inhibitors for cancer treatment: Focus on multi-target agents and compounds in clinical trials.
   Noce B, Di Bello E, Fioravanti R, Mai A. · · 2023 · cited 78× · PMID 36817147 · DOI 10.3389/fphar.2023.1120911
8. Signal pathways and precision therapy of small-cell lung cancer.
   Yuan M, Zhao Y, Arkenau HT, Lao T, et al · · 2022 · cited 72× · PMID 35705538 · DOI 10.1038/s41392-022-01013-y