Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Running, not enrolling · Phase 3

Conditions studied: Small Cell Lung Cancer (SCLC)

In brief

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Key facts

Study ID

NCT05740566

Run by

Amgen

People needed

509

Starts

2023-05-31

Expected to finish

2028-03-26

Last updated by the study team

2026-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
• Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
• Participants who progressed or recurred following 1 platinum-based regimen.
• Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Minimum life expectancy of 12 weeks.
• Adequate organ function.

You may not qualify if…

• Disease Related
• Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
• Diagnosis or evidence of leptomeningeal disease.
• Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.
• Other Medical Conditions
• Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.
• History of solid organ transplantation.
• History of other malignancy within the past 2 years, with exceptions defined in the protocol.
• Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to first dose of study treatment.
• History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
• Presence or history of viral infection based on criteria per protocol.
• Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
• Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
• Evidence of interstitial lung disease or active, non-infectious pneumonitis.
• Prior/Concomitant Therapy
• Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial or participation in any tarlatamab or any other DLL3 targeted agent clinical trial.
• Prior therapy with any selective inhibitor of the DLL3 pathway.
• Participant received more than one prior systemic therapy regimen for SCLC.
• Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.
• Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
• Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.
• Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.
• Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.
• Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.
• Major surgical procedures within 28 days prior to first dose of study treatment.

Where it is running

• Universitaetsklinikum Essen — Essen, Germany
• Guys Hospital — London, United Kingdom
• Christie Hospital — Manchester, United Kingdom
• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
• Alaska Oncology and Hematology — Anchorage, Alaska, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• University of California Los Angeles — Santa Monica, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Illinois Chicago — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Pikeville Medical Center — Pikeville, Kentucky, United States
• Our Lady of the Lake Cancer Institute — Baton Rouge, Louisiana, United States
• Trinity Health Saint Joseph Mercy Ann Arbor — Ann Arbor, Michigan, United States
• University of Minnesota Cancer Center — Minneapolis, Minnesota, United States
• University of Missouri Health Care — Columbia, Missouri, United States
• Summit Medical Group, Overlook Oncology Center — Summit, New Jersey, United States
• New York University Grossman School of Medicine and New York University Langone Hospitals — New York, New York, United States
• Perlmutter Cancer Center at New York University Langone Hospital----Long Island — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Northport Veterans Affairs Medical Center — Northport, New York, United States
• Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
• Sanford Oncology Clinic and Pharmacy — Sioux Falls, South Dakota, United States
• University of Tennessee Medical Center Knoxville — Knoxville, Tennessee, United States
• Universitaetsklinikum Dresden — Dresden, Germany

Full record on ClinicalTrials.gov

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