Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (DeLLphi-304)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 490

Inclusion Criteria

Subject 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 relapsed/refractory SCLC with demostrated progression or relapse, Subject has 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.

Exclusion Criteria

symptomatic central nervous system (CNS) metastases or leptomeningeal disease., Active autoimmune disease that has required systemic treatment within the past 2 years or any other diseases requiring immunosuppressive therapy., Presence or history of viral infected as defined in protocol, History of solid organ transplantation., History of other malignancy within the past 2 years, Myocardial infarction and/or symptomatic congestive heart failure and arterial thrombosis within 12 months prior to first dose of study treatment., Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of IP., 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, Any previous diagnosis of NSCLC, or mixed SCLC NSCLC histology, Male subjects with a female partner of childbearing potential or pregnant who are unwilling to practice sexual abstinence or use contraception or abstain from donating sperm or donate eggs during treatment, Subject has known sensitivity or is contraindicated to any of the products or components to be administered during dosing, Evidence of interstitial lung disease or active, non-infectious pneumonitis., Prior anti-cancer therapy within 21 days prior to first dose of IP., Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions, Use of herbal or medications known to be moderate or strong inhibitors of membrane transporters P-gp and/or BCRP or CYP3A enzymes within 7 days or strong inducers of CYP3A within 28 days prior to the first dose of IP., Subjects who have reached the limit dose of prior treatment with cardiotoxic drugs, Live and live-attenuated vaccines within 14 days prior to the start of study treatment, Prior history of immune checkpoint inhibitors resulting in protocol defined events

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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