A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

Running, not enrolling · Phase 2

Conditions studied: Relapsed/Refractory Small Cell Lung Cancer

In brief

The main aim of this study is to: * evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] by investigator) of 2 dose levels of tarlatamab for Part 1 only * evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2 * evaluate safety of reduced mandatory monitoring period in Cycle 1 at selected dose of tarlatamab for Part 3

Key facts

Study ID: NCT05060016
Run by: Amgen
People needed: 222
Starts: 2021-12-01
Expected to finish: 2027-12-30
Last updated by the study team: 2026-07-22

Who can join

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

You may qualify if…

Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
Male and female participants ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent.
Histologically or cytologically confirmed relapsed/refractory SCLC
Participants who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy.
Participants willing to provide archived tumor tissue samples or willing to undergo pretreatment tumor biopsy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 1.
Minimum life expectancy of 12 weeks.
Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of tarlatamab.
Participants with treated brain metastases are eligible provided they meet defined criteria.

You may not qualify if…

Disease Related
Untreated or symptomatic brain metastases and leptomeningeal disease.
Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
Participants who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
Unresolved toxicity from prior anti-tumor therapy, defined as per protocol.
Other Medical Conditions
History of other malignancy within the past 2 years, with exceptions
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of tarlatamab.
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.
Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab.
Presence of any indwelling line or drain.
History of hypophysitis or pituitary dysfunction.
Exclusion of hepatitis infection based on the results and/or criteria per protocol.
Major surgery within 28 days of first dose of tarlatamab.
History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Subject is eligible if no acute symptoms of coronavirus disease 2019 (COVID-19) within 14 days prior to first dose of tarlatamab (counted from day of positive test for asymptomatic subjects).
Prior/Concomitant Therapy
Participant received prior therapy with tarlatamab.
Prior anti-cancer therapy within 28 days prior to first dose of tarlatamab.
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 tarlatamab.
The following vaccines (live and live-attenuated vaccines) are excluded during the following study periods:
Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study. Live viral non-replicating vaccine (e.g. Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care and institutional guidelines.
End of study treatment: Live and live-attenuated vaccines can be used when at least 42 days (5X half-life of tarlatamab) have passed after the last dose of tarlatamab.
Other Exclusions
Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.

Where it is running

University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Christiana Care Health Services — Newark, Delaware, United States
Moffitt Cancer Center — Tampa, Florida, United States
Winship Cancer Institute — Atlanta, Georgia, United States
University of Iowa — Iowa City, Iowa, United States
Dana Farber - Harvard Cancer Center — Boston, Massachusetts, United States
Henry Ford Health System — Detroit, Michigan, United States
Dartmouth Hitchcock Medical Center — Hanover, New Hampshire, United States
Duke University Medical Center — Durham, North Carolina, United States
Wake Forest Baptist Comprehensive Cancer Research Center — Winston-Salem, North Carolina, United States
Oncology Hematology Care Inc — Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
University of Pittsburgh Medical Center Cancer Pavillion — Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute — Nashville, Tennessee, United States
West Virginia University Health Sciences Center — Morgantown, West Virginia, United States
Universitaetsklinikum Krems — Krems, Austria
Landeskrankenhaus Salzburg — Salzburg, Austria
Universitair Ziekenhuis Gent — Ghent, Belgium
Grand Hopital de Charleroi - Site Saint Joseph — Gilly, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Belgium
Rigshospitalet — Copenhagen, Denmark
Centre Hospitalier Universitaire Nord — Marseille, France
Institut Curie — Paris, France
Centre Hospitalier Lyon Sud — Pierre-Bénite, France
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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