NCT04885998CompletedPhase 1
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination With AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Source: ClinicalTrials.gov · Last updated 29 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 10 May 2021
- Start date
- 27 Sept 2021
- Primary completion date
- 12 Jul 2023
- Lead sponsor
- Amgen
- Diseases
- Lung cancer
- NCT number
- NCT04885998
- EudraCT number
- 2020-005957-26
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 23
- From 27 Sept 2021 to the primary completion date, 12 Jul 2023
- 17 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within 28 days of first dose of tarlatamab
- 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
Other illness
- History of other malignancy within the past 2 years with exceptions
- Untreated or symptomatic brain metastases and leptomeningeal disease
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Universitaetsklinikum Allgemeines Krankenhaus Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| National Cancer Centre Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Northwestern University, Robert H Lurie Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Tennessee Oncology, PLLC Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Wake Forest Baptist Comprehensive Cancer Research Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.