Study Comparing Tarlatamab with Standard Chemotherapy in Relapsed Small Cell Lung Cancer
Sponsor: Amgen
Sponsor score: 60
ClinicalTrials ID:NCT05740566
This clinical trial is comparing a new treatment, tarlatamab, with standard chemotherapy to see which is more effective at helping patients with relapsed small cell lung cancer live longer.
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to find out if tarlatamab can help patients with relapsed small cell lung cancer live longer compared to the usual chemotherapy treatments.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent before starting any study activities.
- Must be 18 years or older.
- Must have a confirmed diagnosis of small cell lung cancer that has worsened or returned.
- Must have had one previous treatment with a platinum-based chemotherapy.
- Must have measurable cancer as per specific medical criteria within 21 days before starting the study.
- Must be in good overall health with an ECOG performance status of 0 or 1.
- Must have a life expectancy of at least 12 weeks.
- Must have adequate organ function.
Exclusion Criteria
- Have active symptoms of cancer spread to the brain, with some exceptions.
- Have a diagnosis of cancer spread to the membranes around the brain and spinal cord.
- Have had serious side effects from previous immune therapy.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have had an organ transplant.
- Have had another cancer in the past 2 years, with some exceptions.
- Have had a heart attack or severe heart failure in the past year.
- Have had a stroke or similar event in the past year.
- Have certain viral infections.
- Are taking steroids or other immune-suppressing drugs within 7 days before starting the study.
- Have an active infection needing antibiotics within 7 days before starting the study.
- Have lung disease or inflammation.
- Have had previous treatment with tarlatamab or similar drugs.
- Have had more than one previous treatment for small cell lung cancer.
- Are currently receiving other cancer treatments, with some exceptions.
- Are taking certain medications that affect drug processing in the body.
- Have had major surgery within 28 days before starting the study.
- Have had live vaccines within 14 days before starting the study.
- Are participating in another clinical trial or have recently finished one.
- Have a history of certain types of lung cancer.
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Men with partners who are pregnant or could become pregnant, unless using contraception.
- Have allergies to study medications.
- Are unable to attend all study visits or follow study procedures.
- Have any other significant health issues that could affect safety or study results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | 36604 | Mobile | Alabama |
| Alaska Oncology and Hematology | 99508 | Anchorage | Alaska |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| University of California Los Angeles | 90404 | Santa Monica | California |
| Northwestern University | 60611 | Chicago | Illinois |
| University of Illinois Chicago | 60612 | Chicago | Illinois |
| Indiana University | 46202 | Indianapolis | Indiana |
| University of Iowa | 52242 | Iowa City | Iowa |
| Pikeville Medical Center | 41501 | Pikeville | Kentucky |
| Our Lady of the Lake Cancer Institute | 70808 | Baton Rouge | Louisiana |
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