Lung Cancer Clinical Trial
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.
Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures
Age greater than or equal to 18 years old at the same time of signing the informed consent
Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
Eastern Cooperative Oncology Group (ECOG) 0 to 1
Participants with treated brain metastases are eligible provided they meet defined criteria
Adequate organ function as defined in protocol
History of other malignancy within the past 2 years with exceptions
Major surgery within 28 days of first dose of tarlatamab
Untreated or symptomatic brain metastases and leptomeningeal disease
Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and the first planned dose of tarlatamab
Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade ≤ 1.
Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab
Participants who received prior tarlatamab therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible
Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents
History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis
Participants with evidence of interstitial lung disease or active, non-infectious pneumonitis
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
History of solid organ transplantation
History of hypophysitis or pituitary dysfunction
Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted
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There are 17 Locations for this study
Chicago Illinois, 60611, United States
Lexington Kentucky, 40536, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Charleston South Carolina, 29425, United States
Nashville Tennessee, 37203, United States
Salt Lake City Utah, 84112, United States
Innsbruck , 6020, Austria
Wien , 1090, Austria
Edegem , 2650, Belgium
Leuven , 3000, Belgium
Kashiwa-shi Chiba, 277-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Singapore , 11907, Singapore
Singapore , 16961, Singapore
Taichung , 40201, Taiwan
Taipei , 11217, Taiwan
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