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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

NCT07328490 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2026-04-28

No results posted yet for this study

Summary

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.

Conditions

  • Extensive-Stage Small Cell Lung Cancer
  • Extrapulmonary Neuroendocrine Carcinoma
  • Small Cell Carcinoma

Interventions

DRUG

Tarlatamab

For both Phase I and Phase II, participants will receive a step dose of 1 mg of Tarlatamab (IV) followed by a full dose of 10 mg starting 7 days later (i.e., step dosing phase). Cycle 1 will begin following the Tarlatamab step-dosing (i.e., 14 days after the first dose and 7 days after the second dose of Tarlatamab alone) with participants receiving a combination of Tarlatamab (full dose) and Sacituzumab Govitecan (IV 7.5 or 10 mg/Kg) on day 1, SG alone on day 8 and Tarlatamab alone on day 15 of every cycle (4-week cycles) for up to 2 years or until disease progression/death, development of intolerable side effects.

DRUG

Sacituzumab Govitecan

For both Phase I and Phase II, participants will receive a step dose of 1 mg of Tarlatamab (IV) followed by a full dose of 10 mg starting 7 days later (i.e., step dosing phase). Cycle 1 will begin following the Tarlatamab step-dosing (i.e., 14 days after the first dose and 7 days after the second dose of Tarlatamab alone) with participants receiving a combination of Tarlatamab (full dose) and Sacituzumab Govitecan (IV 7.5 or 10 mg/Kg) on day 1, SG alone on day 8 and Tarlatamab alone on day 15 of every cycle (4-week cycles) for up to 2 years or until disease progression/death, development of intolerable side effects.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Anish Thomas, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-25
Primary Completion
2026-04-25
Completion
2026-04-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07328490 on ClinicalTrials.gov