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Monoclonal Antibodies

Tarlatamab Combo for Small Cell Lung Cancer

Phase 1
Recruiting
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

Summary

This trial is testing a new drug to see if it is safe and effective when used with other drugs to treat cancer.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
Number of Participants with Clinically Significant Changes in Vital Signs
+3 more
Secondary outcome measures
6-month Progression-free Survival (PFS)
Disease Control Rate(DCR)
Duration of Response (DOR)
+3 more

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
Carboplatin
2014
Completed Phase 3
~6670
Durvalumab
2017
Completed Phase 2
~3840
Etoposide
2010
Completed Phase 3
~2440
Atezolizumab
2017
Completed Phase 3
~5860

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.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,392 Previous Clinical Trials
1,380,780 Total Patients Enrolled
MDStudy DirectorAmgen
937 Previous Clinical Trials
926,927 Total Patients Enrolled

Media Library

Small Cell Lung Cancer Research Study Groups: Part 1: Dose Exploration Combination Regimen 1, Part 5: Dose Exploration Maintenance, Part 7: Dose Expansion, Part 4: Dose Expansion, Part 3: Dose Exploration Combination Regimen 3, Part 8: Dose Expansion Maintenance, Part 9: Dose Expansion Maintenance, Part 2: Dose Exploration Combination Regimen 2, Part 6: Dose Expansion Maintenance
Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05361395 — Phase 1
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361395 — Phase 1
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