Principal Investigator:
Study Sponsor: Amgen, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: II
Purpose of study: This study is being done to learn more about tarlatamab in people with Small Cell Lung Cancer (SCLC); a type of fast-growing cancer that forms in tissues of the lung and can spread to other parts of the body) that has progressed following platinum-based chemotherapy (a type of cancer treatment that involves drugs containing platinum ion compounds). This cancer type may have an excess amount of protein markers (e.g., delta-like ligand 3 [DLL3]; a protein possibly causing cells to grow more quickly and multiply abnormally). This study is being done to see how well tarlatamab works and whether it causes any side effects. This study will also look at what doses of tarlatamab are safe for people to take.
Inclusion Criteria:
– Must be at least 18 years or older.
– Histologically or cytologically confirmed small cell lung cancer with demonstrated progression or relapse.
– Patient has progressed or recurred after 1 platinum-based treatment.
– Must have measurable disease per RECIST 1.1 within 21-day screening period.
– Must have an ECOG of 0 – 1.
– Minimum life expectancy of at least 12 weeks.
– Adequate organ function as determined by local lab tests.
Exclusion Criteria:
– Has a previous diagnosis of non-small cell lung cancer (NSCLC), including EGFR mutation positive NSCLC transformed into small cell lung cancer (SCLC).
– Symptomatic brain metastasis (Some exceptions apply. Can be discussed in greater detail with research team and physician).
– History of other cancer within the last 2 years (some exceptions apply, such as those felt to be low risk for recurrence as determined by your physician. Discuss with physician and research team for a detailed list of allowed exceptions).
– Has Leptomeningeal disease.
– Has lung disease or active pneumonitis.
– Active autoimmune disease that requires treatment within the last 2 years, or that requires immunosuppressive therapy while on study. (Replacement therapy is allowed)
– Has significant heart condition or history within the last 6 months prior to first dose of study drug.
– is HIV positive (patients with undetectable viral load are allowed to participate in study, as long as regular monitoring occurs to watch for reactivation).
– is Hepatitis B and C positive (Some may be eligible pending lab tests).
– Has had a major surgery within 21 days prior to first dose of study drug.
– Has received a live vaccine within the last 4 weeks prior to first dose.
Additional criteria may apply and should be discussed with the research team and physician.
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com
