Tarlatamab given under the skin vs by IV in extensive-stage small cell lung cancer after platinum therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional study comparing subcutaneous tarlatamab to the intravenous route. The primary goal is to show non-inferiority of the PK profile for SC administration and to characterize the drug's efficacy, safety, and tolerability after prior platinum-based treatment. Eligible participants have progressed on at least one platinum-containing regimen, measurable disease, ECOG 0-1, and sufficient organ function, with CNS metastases allowed under protocol-specific conditions. The study is sponsored by Amgen and will enroll at sites in Florida, Michigan, and Nebraska. Outcomes will inform whether SC administration can simplify administration while maintaining efficacy and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol.

Exclusion Criteria:

Disease Related

\- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.

Other Medical Conditions

* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.
* History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
* Current evidence or history of non-infectious pneumonitis/ILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.
* History of other malignancy within the past 2 years, with exceptions defined in the protocol.
* Presence or history of viral infection based on criteria per protocol.
* History of solid organ transplantation.
* 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.
* Known sensitivity or a contraindication to any of the products or components.
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

Prior/Concomitant Therapy

* Prior systemic anticancer therapy within 30 days of enrolment
* Prior history of severe or life-threatening events from any immune-mediated therapy.
* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
* Live and live-attenuated vaccines within 28 days prior to the start of study treatment.
* Receiving another anticancer therapy for a malignancy other than SCLC.
* More than 1 prior line of anticancer therapy for SCLC.
* Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
* Treatment in an alternative investigational trial within 28 days prior to enrolment.
* History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient.

Other Exclusions

* Participants unable to have SC injections administered in the abdomen or thigh.
* Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements.
* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.

Where it's running

• University of Florida Health Cancer Center at Orlando Health
  Orlando, Florida, United States Recruiting
• Cancer and Hematology Centers of Western Michigan
  Grand Rapids, Michigan, United States Recruiting
• Oncology Hematology West PC
  Omaha, Nebraska, United States Recruiting
• Lyell McEwin Hospital
  Elizabeth Vale, South Australia, Australia Recruiting
• Beijing Chaoyang Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.