AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
NCT ID: NCT04885998
Last Updated: 2025-09-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2021-09-27
2024-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: Dose Exploration
The recommended phase 2 target dose (RP2D) of tarlatamab in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD).
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
AMG 404
AMG 404 will be administered as an intravenous (IV) infusion.
Phase 2: Dose Expansion
Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study.
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
AMG 404
AMG 404 will be administered as an intravenous (IV) infusion.
Interventions
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Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
AMG 404
AMG 404 will be administered as an intravenous (IV) infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Northwestern University, Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
Wake Forest Baptist Comprehensive Cancer Research Center
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, , Austria
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, , Belgium
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
National University Hospital
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2020-005957-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20200439
Identifier Type: -
Identifier Source: org_study_id
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