Tarlatamab + Sacituzumab Govitecan for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Background:
Small-cell lung cancer (SCLC) is the most deadly form of lung cancer. It kills at least 250,000 worldwide each year. Extra-pulmonary neuroendocrine cancer (EP-NEC) is a similar type of cancer that develops anywhere other than the lungs. EP-NEC is also very aggressive. Better treatments are needed for these cancers.
Objective:
To test 2 drugs (tarlatamab combined with sacituzumab govitecan \[SG\]) in people with SCLC or EP-NEC.
Eligibility:
People aged 18 years and older with SCLC or EP-NEC that either did not respond to or returned after treatment.
Design:
Participants will be screened with a physical exam, blood tests, heart function testing, and imaging scans.
Both study drugs are given intravenously (through a needle in the arm). Participants will receive a small starter dose of tarlatamab (1 mg) 2 weeks before beginning regular treatment, followed by the full dose (10 mg) one week later. Treatment then follows a repeating 4-week cycle: tarlatamab (10 mg) on days 1 and 15, and sacituzumab govitecan (7.5 or 10 mg/kg) on days 1 and 8. Treatment continues for up to 2 years, unless the cancer worsens, the participant passes away, or side effects become too severe.
Participants will have regular check-ups including physical exams, blood tests, and imaging scans to monitor safety and treatment response. Blood and tumor samples will be collected for research purposes.
After stopping treatment, participants will return for a safety check at 30 days, then be contacted every 3 months to check on their health and survival. Those who stop treatment for reasons other than cancer progression will continue CT scans every 6 weeks until their disease progresses.
Who Is on the Research Team?
Anish Thomas, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Small Cell Lung Cancer (SCLC) or Extra-pulmonary Neuroendocrine Cancer (EP-NEC) that's come back or didn't respond to treatment. They must have a certain level of physical fitness and meet specific blood test criteria, including adequate hemoglobin, neutrophil, and platelet levels.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a small starter dose of tarlatamab followed by a full dose and sacituzumab govitecan in a repeating 4-week cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment, with regular check-ups and imaging scans
Long-term follow-up
Participants who stop treatment for reasons other than cancer progression will continue CT scans every 6 weeks until disease progression
What Are the Treatments Tested in This Trial?
Interventions
- Sacituzumab Govitecan
- Tarlatamab
Trial Overview
The study tests Tarlatamab combined with Sacituzumab Govitecan in patients with SCLC or EP-NEC. Participants receive these drugs intravenously in cycles: a starter dose followed by regular doses every two weeks for up to two years unless side effects are too severe.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Maximum tolerated dose (MTD) Tarlatamab and Sacituzumab Govitecan
Dose escalated Tarlatamab and Sacituzumab Govitecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
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