What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, enzyme inhibitors, and immunotherapy. Chemotherapy often leads to side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Enzyme inhibitors like bomedemstat may cause side effects including fatigue, nausea, and potential blood-related issues. Immunotherapy, such as atezolizumab, can result in immune-related side effects like skin reactions, endocrine disorders, pneumonitis, and, in severe cases, organ inflammation. Combining these treatments may enhance efficacy but also increases the risk of compounded side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC) that are similar to those being studied in the trial involving Bomedemstat and Atezolizumab. Atezolizumab, an immunotherapy drug, has been approved for use in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of extensive-stage SCLC. This approval is based on its ability to help the body's immune system attack cancer cells. While specific enzyme inhibitors like Bomedemstat are still under investigation, other enzyme inhibitors have not yet been widely approved for SCLC treatment. The focus remains on combining immunotherapy with traditional chemotherapy to improve patient outcomes.

What other types of research exist?

Promising novel alternatives for SCLC treatment in 2024 include: 1) Bispecific antibodies like Blinatumomab, which are being incorporated into chemotherapy regimens for other cancers and may offer new therapeutic options. 2) Antibody-drug conjugates (ADCs) such as BMS-986148, which have shown preliminary efficacy in solid tumors and could be explored for SCLC. 3) PD-1/PD-L1 inhibitors like Pembrolizumab and Nivolumab, which have demonstrated effectiveness in various cancers and may provide additional immunotherapy options for SCLC patients.

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Histone Methyltransferase Inhibitor

Bomedemstat + Immunotherapy for Small Cell Lung Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for Small Cell Lung Cancer (SCLC) include enzyme inhibitors and immunotherapy. Bomedemstat, an enzyme inhibitor, works by blocking specific enzymes necessary for tumor cell growth, thereby inhibiting cancer progression. Atezolizumab, an immunotherapy drug, is a monoclonal antibody that helps the immune system recognize and attack cancer cells by targeting the PD-L1 protein, which tumors use to evade immune detection. These treatments are significant for SCLC patients as they offer targeted approaches to slow down or stop cancer growth and enhance the body's natural defenses against the disease, potentially improving outcomes and survival rates.

Phase 1 & 2

Waitlist Available

Led By Renato Martins

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to swallow capsules

Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

Must not have

Uncontrolled active infection

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or LSD1 inhibitors (i.e., monoamine oxidase inhibitors; MAOIs) that contraindicates their participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of study enrollment up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well bomedemstat and atezolizumab work together in treating patients with severe small cell lung cancer. Bomedemstat blocks enzymes to stop cancer growth, while atezolizumab helps the immune system fight the cancer. Atezolizumab has been shown to improve survival in various types of lung cancer, including non-small cell lung cancer and small cell lung cancer, often in combination with chemotherapy.

Who is the study for?

Adults over 18 with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who've completed initial chemoimmunotherapy and are eligible for maintenance atezolizumab. They must have a life expectancy of at least 12 weeks, adequate organ function, no prior ES-SCLC systemic therapy other than specified treatments, and not be pregnant or breastfeeding. Participants should agree to contraception use and not have certain autoimmune diseases or hypersensitivities.

What is being tested?

The trial is testing bomedemstat in combination with the immunotherapy drug atezolizumab to see if they're more effective for treating ES-SCLC. Bomedemstat may halt tumor growth by inhibiting enzymes needed for cell proliferation while atezolizumab could boost the immune system's ability to fight cancer.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, blood disorders like anemia or clotting issues, potential digestive problems, increased risk of infections due to immune modulation, and specific drug-related sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow pills.

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I can take care of myself but might not be able to do heavy physical work.

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My lung cancer is confirmed to be extensive stage small-cell type.

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I've had 4 cycles of platinum-etoposide and 3-4 cycles of immune therapy for small cell lung cancer.

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My blood clotting time is within normal range and I'm not on blood thinners.

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I agree to use birth control during and for 28 days after the study treatment.

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My kidney function, measured by GFR, is adequate.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any ongoing infections that aren't responding to treatment.

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I am allergic to bomedemstat, LSD1 inhibitors, or similar drugs.

Select...

I have only had four cycles of specific chemotherapy and immunotherapy for my small cell lung cancer.

Select...

I have small cell lung cancer that hasn't been treated yet.

Select...

I have or had lung inflammation that needed treatment with strong medication.

Select...

I have an autoimmune disease and have been on systemic immunosuppressants.

Select...

I am currently taking MAOI medications.

Select...

I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed during the study.

Select...

I am not taking any medication that is not allowed in this study.

Select...

I have a bleeding disorder or a history of very low platelet counts.

Select...

I have another cancer that my doctor thinks is important.

Select...

I have HIV or active hepatitis B/C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of study enrollment up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of study enrollment up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of study enrollment up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence Patients Experiencing Adverse Events

Number of Participants Experiencing a Dose Limiting Toxicity (DLT)

Progression Free Survival

Secondary study objectives

Overall Survival

Side effects data

From 2022 Phase 1 & 2 trial • 90 Patients • NCT03136185

55%

Thrombocytopenia

36%

Contusion

27%

Dysgeusia

27%

Oedema peripheral

27%

Arthralgia

27%

Back pain

27%

Depression

27%

Nausea

27%

Anaemia

27%

Constipation

27%

Hypocalcaemia

18%

Dyspnoea

18%

Fatigue

18%

Palpitations

18%

Decreased appetite

18%

Muscular weakness

18%

Hyperuricaemia

18%

Hyponatraemia

18%

Cough

18%

Fall

18%

Asthenia

18%

Abdominal pain

18%

Alopecia

18%

Lymphopenia

18%

Blood uric acid increased

18%

Insomnia

18%

Pruritus

18%

Dizziness

18%

Diarrhoea

18%

Pain in extremity

18%

Hypertension

18%

International normalised ratio increased

18%

Activated partial thromboplastin time prolonged

18%

Dry mouth

18%

Urine abnormality

Pneumonitis

Urinary incontinence

Skin ulcer

Cellulitis

Hypotension

Gout

Headache

Wound secretion

Blood bilirubin increased

Blood magnesium decreased

Blood thyroid stimulating hormone increased

Hypophosphataemia

Petechiae

Hyperglycaemia

Non-cardiac chest pain

Abdominal distension

Stress cardiomyopathy

Lacrimation increased

Myalgia

Blood albumin decreased

Sinus tachycardia

Sepsis

Musculoskeletal chest pain

Blood lactate dehydrogenase increased

Aortic arteriosclerosis

Confusional state

Abdominal pain upper

Blood creatinine increased

Bone pain

Epistaxis

Balance disorder

Eye oedema

Dry skin

Splenic infarction

Catathrenia

Traumatic haematoma

Leukopenia

Rash

Blood alkaline phosphatase increased

Hypokalaemia

Breast pain

Pelvic pain

Anal pruritus

Myocardial ischaemia

Neck pain

Flank pain

Disturbance in attention

Hyperhidrosis

Eczema

Pyrexia

Dysphagia

Hyperactive pharyngeal reflex

Rash maculo-papular

Heart rate irregular

Cachexia

Nail disorder

Stomatitis

Neuralgia

Pleural effusion

Flatulence

Haematoma

Neutropenia

Pallor

Chest pain

Drooling

Vomiting

Early satiety

Calcium ionised decreased

Mouth haemorrhage

Vulvovaginal pruritus

Abdominal wall haematoma

Hypervolaemia

100%

80%

60%

40%

20%

Study treatment Arm

Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d

Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d

Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d

Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d

Ph 2b PMF: Bomedemstat 0.5 mg/kg/d

Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d

Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d

Ph 2b PMF: Bomedemstat 0.6 mg/kg/d

Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (bomedemstat, atezolizumab)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bomedemstat

2021

Completed Phase 2

~250

Atezolizumab

2016

Completed Phase 3

~5860

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Small Cell Lung Cancer (SCLC) include enzyme inhibitors and immunotherapy. Bomedemstat, an enzyme inhibitor, works by blocking specific enzymes necessary for tumor cell growth, thereby inhibiting cancer progression. Atezolizumab, an immunotherapy drug, is a monoclonal antibody that helps the immune system recognize and attack cancer cells by targeting the PD-L1 protein, which tumors use to evade immune detection. These treatments are significant for SCLC patients as they offer targeted approaches to slow down or stop cancer growth and enhance the body's natural defenses against the disease, potentially improving outcomes and survival rates.

Immunotherapy treatments for small-cell lung cancer: past, present and future.