Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)

Prior treatment

• 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.
• 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.
• 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.

Other illness

• Disease Related
• Other Medical Conditions
• 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.
• History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient.
  • Other Exclusions
• 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.

Lab values

• \- 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

• Known sensitivity or a contraindication to any of the products or components.
• 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.

• 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.