Lung Cancer Clinical Trial
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Summary
This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
Eligibility Criteria
Inclusion Criteria:
Participant has provided informed consent 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.
Histologically or cytologically confirmed Extended Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
Eastern Cooperative Oncology Group (ECOG) 0 to 1.
Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
Adequate organ function as defined in protocol.
Exclusion Criteria:
History of other malignancy within the past 2 years with exceptions.
Major surgery within 28 days of study day 1.
Untreated or symptomatic brain metastases and leptomeningeal disease.
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 immune-related colitis.
History or 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 study treatment.
History of solid organ transplantation.
History of hypophysitis or pituitary dysfunction.
History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
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 42 Locations for this study
Los Angeles California, 90033, United States
Newark Delaware, 19713, United States
Detroit Michigan, 48202, United States
New Brunswick New Jersey, 08901, United States
New York New York, 10016, United States
Chapel Hill North Carolina, 27599, United States
Sioux Falls South Dakota, 57105, United States
Seattle Washington, 98104, United States
Morgantown West Virginia, 26506, United States
Camperdown New South Wales, 2050, Australia
Edegem , 2650, Belgium
Gent , 9000, Belgium
Hasselt , 3500, Belgium
Roeselare , 8800, Belgium
Quebec , G1R 2, Canada
Kobenhavn , 2100, Denmark
Lyon cedex 8 , 69373, France
Saint Herblain , 44800, France
Villejuif , 94805, France
Dresden , 01307, Germany
Essen , 45147, Germany
Freiburg , 79106, Germany
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Petah Tikva , 49414, Israel
Catanzaro , 88100, Italy
Monza (MB) , 20900, Italy
Rome , 00144, Italy
Kashiwa-shi Chiba, 277-8, Japan
Koto-ku Tokyo, 135-8, Japan
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Groningen , 9713 , Netherlands
Badalona Cataluña, 08916, Spain
Barcelona Cataluña, 08035, Spain
Madrid , 28041, Spain
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Tainan , 70403, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
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