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.
Checked against the public recordLast updated Sep 29, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Amgen
- Interventions being studied
- Drug: Tarlatamab; Drug: AMG 404
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Northwestern University, Robert H Lurie Comprehensive Cancer CenterChicago, Illinois
- University of KentuckyLexington, Kentucky
- Wake Forest Baptist Comprehensive Cancer Research CenterWinston-Salem, North Carolina
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- Medical University of South CarolinaCharleston, South Carolina
- Tennessee Oncology, PLLCNashville, Tennessee
- Huntsman Cancer InstituteSalt Lake City, Utah
- Medizinische Universitaet InnsbruckInnsbruck
- Universitaetsklinikum Allgemeines Krankenhaus WienVienna
- Universitair Ziekenhuis AntwerpenEdegem
- Universitair Ziekenhuis Leuven - Campus GasthuisbergLeuven
- National Cancer Center Hospital EastKashiwa-shi, Chiba
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 29, 2025. Always confirm current availability with the study team.