Tarlatamab Combo for Small Cell Lung Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Amgen
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
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.Inclusion Criteria
My lung cancer is in the extensive stage and I haven't had any systemic treatment for it.
I am 18 years or older and can sign the consent form.
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
I have had immune-related inflammation of my colon.
I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
I have a history of lung disease or inflammation not caused by infection.
I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.
I had severe side effects from immune therapy that stopped my treatment.
I haven't had signs of a serious infection in the last week.
I have had a solid organ or bone marrow transplant.
I have had issues with my pituitary gland.
I have not had major surgery in the last 28 days.
Treatment Details
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.
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
Atezolizumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
🇪🇺 Approved in European Union as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
New York University Grossman School of Medicine and New York University Langone HospitalsNew York, NY
West Virginia University Health Sciences CenterMorgantown, WV
CHU de Quebec Hopital de l Enfant JesusQuebec, Canada
New York University Langone Medical CenterNew York, NY
More Trial Locations
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Who is running the clinical trial?
AmgenLead Sponsor