Lung Cancer Clinical Trial

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Exceptions:

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT04885998

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 17 Locations for this study

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Northwestern University, Robert H Lurie Comprehensive Cancer Center
Chicago Illinois, 60611, United States
University of Kentucky
Lexington Kentucky, 40536, United States
Wake Forest Baptist Comprehensive Cancer Research Center
Winston-Salem North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Medizinische Universitaet Innsbruck
Innsbruck , 6020, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Wien , 1090, Austria
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
National University Hospital
Singapore , 11907, Singapore
National Cancer Centre Singapore
Singapore , 16961, Singapore
Chung Shan Medical University Hospital
Taichung , 40201, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT04885998

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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