Status:
COMPLETED
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Lead Sponsor:
Amgen
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04885998
Start Date
September 27 2021
End Date
September 11 2024
Last Update
September 29 2025
Active Locations (17)
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1
Northwestern University, Robert H Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
2
University of Kentucky
Lexington, Kentucky, United States, 40536
3
Wake Forest Baptist Comprehensive Cancer Research Center
Winston-Salem, North Carolina, United States, 27157
4
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106