🏛️ Verified NIH Record • Updated 2025-11-17

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (NCT03319940)

A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Amgen

🩺 Plain-English Summary (8th-Grade Level)

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (10 items).

Location: City of Hope National Medical Center — Duarte, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions
  • Major surgery within 28 days of first dose tarlatamab
  • Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
  • Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
  • Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
  • Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
  • Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (39 Sites)

Showing the first 25 of 39 sites.

  • City of Hope National Medical Center — Duarte, California
  • Yale New Haven Hospital — New Haven, Connecticut
  • Moffitt Cancer Center — Tampa, Florida
  • Winship Cancer Institute — Atlanta, Georgia
  • University of Chicago — Chicago, Illinois
  • Ochsner Clinic Foundation — New Orleans, Louisiana
  • John Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland
  • Henry Ford Health System — Detroit, Michigan
  • Washington University — St Louis, Missouri
  • Memorial Sloan Kettering Cancer Center — New York, New York
  • University Hospitals Cleveland Medical Center — Cleveland, Ohio
  • The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic — Columbus, Ohio
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania
  • University of Pittsburgh Medical Center Cancer Pavillion — Pittsburgh, Pennsylvania
  • Sarah Cannon Research Institute — Nashville, Tennessee
  • Chris OBrien Lifehouse — Camperdown, New South Wales
  • Medizinische Universitaet Graz — Graz,
  • Landeskrankenhaus Salzburg — Salzburg,
  • Gustave Roussy — Villejuif,
  • Universitaetsklinikum Wuerzburg — Würzburg,
  • Prince of Wales Hospital — Shatin, New Territories,
  • National Cancer Center Hospital East — Kashiwa-shi, Chiba
  • National Cancer Center Hospital — Chuo-ku, Tokyo
  • Wakayama Medical University Hospital — Wakayama, Wakayama
  • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis — Amsterdam,

📞 Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗