What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer, such as etoposide and carboplatin chemotherapy, often cause side effects like nausea, vomiting, hair loss, fatigue, and increased infection risk due to lowered white blood cell counts. PD-L1 inhibitors, like atezolizumab, can lead to immune-related side effects including fatigue, rash, diarrhea, and inflammation of organs such as the lungs, liver, and endocrine glands. Combining these treatments may amplify these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC) that involve PD-L1 inhibitors and chemotherapy. Atezolizumab, a PD-L1 inhibitor, in combination with carboplatin and etoposide, has been approved for the first-line treatment of extensive-stage SCLC. This combination has shown improved survival rates compared to chemotherapy alone. Additionally, nivolumab, another PD-L1 inhibitor, has been approved for the treatment of SCLC after the failure of platinum-based chemotherapy and at least one other line of therapy. These approvals highlight the integration of immunotherapy with traditional chemotherapy in the management of SCLC.

What other types of research exist?

Promising, novel alternatives to Tarlatamab for Small Cell Lung Cancer patients include: 1) Rilotumumab combined with etoposide and carboplatin or cisplatin, and 2) Ganitumab combined with etoposide and carboplatin or cisplatin. Both are being studied as first-line treatments for extensive-stage SCLC.

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Monoclonal Antibodies

Tarlatamab Combo for Small Cell Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.

Age greater than or equal to 18 years old at the same time of signing the informed consent.

Must not have

History of immune-related colitis.

Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called tarlatamab combined with treatments that help the immune system fight cancer, and sometimes with chemotherapy. It targets cancer patients who need new treatment options. Tarlatamab attacks cancer cells directly, while other treatments boost the immune response or kill cancer cells.

Who is the study for?

Adults with untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC) can join this trial. They should have had no prior systemic treatment for ES-SCLC, may have treated brain metastases if stable, and must be generally healthy with good organ function and performance status (ECOG 0-1). People who've had major surgery recently, other cancers within 2 years, severe immune reactions to cancer immunotherapy, active autoimmune diseases needing treatment or any form of immunosuppression are excluded.

What is being tested?

The study is testing the safety of a new drug called Tarlatamab combined with Carboplatin and Etoposide chemotherapy drugs plus a PD-L1 inhibitor like Durvalumab or Atezolizumab in patients. It's an early-phase trial to see how well participants tolerate this combination therapy as a first-line treatment for ES-SCLC.

What are the potential side effects?

Possible side effects include immune system reactions that could affect organs like lungs causing pneumonitis, infusion-related reactions during drug administration, potential worsening of autoimmune diseases due to immune stimulation by the drugs being tested.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is in the extensive stage and I haven't had any systemic treatment for it.

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I am 18 years or older and can sign the consent form.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have had immune-related inflammation of my colon.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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I have a history of lung disease or inflammation not caused by infection.

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I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.

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I had severe side effects from immune therapy that stopped my treatment.

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I haven't had signs of a serious infection in the last week.

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I have had a solid organ or bone marrow transplant.

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I have had issues with my pituitary gland.

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I have not had major surgery in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Objective Response (OR)

Side effects data

From 2024 Phase 1 trial • 23 Patients • NCT04885998

71%

Cytokine release syndrome

43%

Anaemia

29%

Vomiting

29%

Fatigue

29%

Neutropenia

29%

Upper respiratory tract infection

29%

Nausea

29%

Thrombocytopenia

14%

Oral fungal infection

14%

Atrioventricular block first degree

14%

Constipation

14%

Dry mouth

14%

Hypokalaemia

14%

Diarrhoea

14%

Infusion related reaction

14%

Mouth ulceration

14%

Hypomagnesaemia

14%

Acute respiratory distress syndrome

14%

Decreased appetite

14%

Pyrexia

14%

COVID-19

14%

Hypoalbuminaemia

14%

Hyponatraemia

14%

Flank pain

14%

Myalgia

14%

Dry skin

14%

Hypertension

14%

Oropharyngeal pain

14%

Dysgeusia

14%

Abdominal distension

14%

Sinus arrhythmia

14%

Cough

14%

Dizziness

14%

Hyperglycaemia

14%

Vitamin D deficiency

100%

80%

60%

40%

20%

Study treatment Arm

Part 2 Dose Expansion Cohort: Tarlatamab Dose B + AMG 404 (SFU1)

Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP)

Part 1 Cohort 3: Tarlatamab Dose A/ Dose D + AMG 404 (EP)

Part 2 Dose Expansion Cohort: Tarlatamab Dose B + AMG 404 (EP)

Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (SFU1)

Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (SFU1)

Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (EP)

Part 1 Cohort 3: Tarlatamab Dose A/ Dose D + AMG 404 (SFU1)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

9Treatment groups

Experimental Treatment

Group I: Part 9: Dose Expansion MaintenanceExperimental Treatment2 Interventions

Expansion with Tarlatamab+Durvalumab

Group II: Part 8: Dose Expansion MaintenanceExperimental Treatment2 Interventions

Expansion of Part 5 with Durvalumab

Group III: Part 7: Dose ExpansionExperimental Treatment4 Interventions

Expansion of Part 1, 2, or 3 with Durvalumab

Group IV: Part 6: Dose Expansion MaintenanceExperimental Treatment4 Interventions

Expansion of Part 5 with Atezolizumab

Group V: Part 5: Dose Exploration MaintenanceExperimental Treatment4 Interventions

Tarlatamab+Atezolizumab

Group VI: Part 4: Dose ExpansionExperimental Treatment4 Interventions

Expansion of Part 1, Part 2, or Part 3 with Atezolizumab

Group VII: Part 3: Dose Exploration Combination Regimen 3Experimental Treatment4 Interventions

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Group VIII: Part 2: Dose Exploration Combination Regimen 2Experimental Treatment4 Interventions

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Group IX: Part 1: Dose Exploration Combination Regimen 1Experimental Treatment4 Interventions

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Carboplatin

2014

Completed Phase 3

~6120

Etoposide

2010

Completed Phase 3

~2960

Atezolizumab

2016

Completed Phase 3

~5860

Tarlatamab

2021

Completed Phase 1

~70

0 / 12Eligibility 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 chemotherapy and immune checkpoint inhibitors. Chemotherapy agents like etoposide and platinum compounds (cisplatin or carboplatin) work by damaging the DNA of cancer cells, leading to cell death. Immune checkpoint inhibitors, such as PD-L1 inhibitors, block proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. Combining these treatments can improve outcomes by attacking the cancer through multiple mechanisms: direct cytotoxic effects from chemotherapy and immune-mediated destruction from checkpoint inhibitors. This multi-faceted approach is crucial for SCLC patients due to the aggressive nature of the disease and its tendency to develop resistance to single-agent therapies.

Advances in systemic therapy of small cell cancer of the lung.