Tarlatamab Combo for Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+51 other locations

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

I have brain metastases but have been treated and am not showing symptoms.

I have had treatment for early-stage small cell lung cancer.

My organs are functioning well.

Exclusion Criteria

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

I am currently on IV antibiotics for an infection but can join the study once it's treated.

I have had immune-related inflammation of my colon.

Participant Groups

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.

Group I: Part 9: Dose Expansion Maintenance Experimental Treatment 2 Interventions

Expansion with Tarlatamab+Durvalumab

Group II: Part 8: Dose Expansion Maintenance Experimental Treatment 2 Interventions

Expansion of Part 5 with Durvalumab

Group III: Part 7: Dose Expansion Experimental Treatment 4 Interventions

Expansion of Part 1, 2, or 3 with Durvalumab

Group IV: Part 6: Dose Expansion Maintenance Experimental Treatment 4 Interventions

Expansion of Part 5 with Atezolizumab

Group V: Part 5: Dose Exploration Maintenance Experimental Treatment 4 Interventions

Tarlatamab+Atezolizumab

Group VI: Part 4: Dose Expansion Experimental Treatment 4 Interventions

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

Group VII: Part 3: Dose Exploration Combination Regimen 3 Experimental Treatment 4 Interventions

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Group VIII: Part 2: Dose Exploration Combination Regimen 2 Experimental Treatment 4 Interventions

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Group IX: Part 1: Dose Exploration Combination Regimen 1 Experimental Treatment 4 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 Nearby Select from list below to view details:

New York University Grossman School of Medicine and New York University Langone Hospitals New York, NY

West Virginia University Health Sciences Center Morgantown, WV

CHU de Quebec Hopital de l Enfant Jesus Quebec, Canada

New York University Langone Medical Center New York, NY

More Trial Locations

Who Is Running the Clinical Trial?

Amgen Lead Sponsor

References