Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Extensive-Stage Small Cell Lung Cancer, Extrapulmonary Neuroendocrine Carcinoma, Small Cell Carcinoma

In brief

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 8 weeks until their disease progresses.

Key facts

Study ID

NCT07328490

Run by

National Cancer Institute (NCI)

People needed

0

Starts

2026-04-25

Expected to finish

2026-04-25

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Receiving any other investigational agents or concurrent systemic anti-cancer therapies. Any previous non-investigational treatment must be completed at least 2 weeks prior to study drug initiation.
• Prior exposure to tarlatamab or other DLL3-targeting agents/T-cell engagers (TCE).
• Requiring radiation therapy during study treatment. Radiation therapy may be allowed if needed for palliative/symptom control (e.g., bone metastasis) but must be completed at least 7 days before study drug initiation.
• Severe and unresolved active autoimmune inflammatory conditions.
• Pregnant women, breastfeeding women, and women planning to become pregnant or donate eggs should not take part in this study.
• Requiring immunosuppressive agents with the exception of those required by protocol, treatment for adverse events, Central Nervous System (CNS) metastases corticosteroid replacement therapy.
• Require live and live-attenuated vaccines during study treatment with tarlatamab or within 4 weeks of first dose of tarlatamab. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. However, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines and are not allowed.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs or other agents used in study.
• Requiring treatment with inhibitors or inducers of UGT1A1 during the planned period of study treatment.
• QTc >= 470 msec or any conditions or factors that may increase the risk of QTc prolongation.
• Uncontrolled intercurrent illness, evaluated by medical history and physical exam which would potentially increase risk to the participant.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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