First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Amgen
Study ID
NCT05361395
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tarlatamab — DRUG
    Tarlatamab will be administered as an intravenous (IV) infusion.
  • Carboplatin — DRUG
    Carboplatin will be administered as an intravenous (IV) infusion.
  • Etoposide — DRUG
    Etoposide will be administered as an intravenous (IV) infusion.
  • Atezolizumab — DRUG
    Atezolizumab will be administered as an intravenous (IV) infusion.
  • Durvalumab — DRUG
    Durvalumab will be administered as an intravenous (IV) infusion.

Study Details

This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.

Key Dates

Start date
Aug 24, 2022
Status verified
Feb 2026
Primary completion
Aug 28, 2028
Completion
Aug 28, 2028

Study Design

Enrollment
184 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Exploration Combination Regimen 1
    Tarlatamab+Atezolizumab+Carboplatin+Etoposide
  • Experimental: Part 2: Dose Exploration Combination Regimen 2
    Tarlatamab+Atezolizumab+Carboplatin+Etoposide
  • Experimental: Part 3: Dose Exploration Combination Regimen 3
    Tarlatamab+Atezolizumab+Carboplatin+Etoposide
  • Experimental: Part 4: Dose Expansion
    Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
  • Experimental: Part 5: Dose Exploration Maintenance
    Tarlatamab+Atezolizumab
  • Experimental: Part 6: Dose Expansion Maintenance
    Expansion of Part 5 with Atezolizumab
  • Experimental: Part 7: Dose Expansion
    Expansion of Part 1, 2, or 3 with Durvalumab
  • Experimental: Part 8: Dose Expansion Maintenance
    Expansion of Part 5 with Durvalumab
  • Experimental: Part 9: Dose Expansion Maintenance
    Expansion with Tarlatamab+Durvalumab

Primary Outcome Measure

Number of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: 24 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Southern California, Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Christiana Care Health ServicesNewarkDelaware19713-
Henry Ford Health SystemDetroitMichigan48202-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
New York University Grossman School of Medicine and New York University Langone HospitalsNew YorkNew York10016-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
Swedish Cancer Institute Medical OncologySeattleWashington98104-
West Virginia University Health Sciences CenterMorgantownWest Virginia26506-

Find similar trials in Los Angeles, CA

By research site
University of Southern California, Norris Comprehensive Cancer Center· Los Angeles, CAChristiana Care Health Services· Newark, DEHenry Ford Health System· Detroit, MIRutgers Cancer Institute of New Jersey· New Brunswick, NJNew York University Grossman School of Medicine and New York University Langone Hospitals· New York, NYThe University of North Carolina at Chapel Hill· Chapel Hill, NC

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