CompletedPhase 1NCT04885998

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

StatusCompleted
PhasePhase 1
U.S. locations17
SponsorAmgen
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Amgen
Interventions being studied
Drug: Tarlatamab; Drug: AMG 404
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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