Who is eligible for clinical trial NCT07531095?

Participants must meet the protocol's inclusion criteria for Small Cell Lung Cancer. The stated age range is 18 Years to 99 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07531095 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-20

Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) (NCT07531095)

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Amgen

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

The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (8 items).

Location: City of Hope Cancer Center Phoenix — Goodyear, Arizona

Age range: 18 Years to 99 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).

Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
Participants with Histologically or cytologically confirmed SCLC:
For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.
For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy. Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated.
Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.
History of interstitial lung disease (ILD)/pneumonitis.
Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.
Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.
Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment.
Enrollment in any tarlatamab clinical trial.

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

📍 All Participating Trial Locations (27 Sites)

Showing the first 25 of 27 sites.

City of Hope Cancer Center Phoenix — Goodyear, Arizona
Moffitt Cancer Center — Tampa, Florida
City of Hope Chicago — Zion, Illinois
Health Partners Cancer Center at Regions Hospital — Saint Paul, Minnesota
New York University Cancer Institute — New York, New York
Baptist Cancer Center — Memphis, Tennessee
Next Virginia — Fairfax, Virginia
Monash Medical Centre — Clayton, Victoria
Institut Jules Bordet — Brussels,
Universitair Ziekenhuis Gent — Ghent,
Ziekenhuis aan de Stroom Augustinus — Wilrijk,
Centre Hospitalier Universitaire de Lyon Hopital Louis Pradel — Bron,
Hopital de la Timone — Marseille,
Gustave Roussy — Villejuif,
Universitaetsklinikum Dresden — Dresden,
Universitaetsklinikum Wuerzburg — Würzburg,
Uniwersyteckie Centrum Kliniczne — Gdansk,
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy — Gliwice,
Hospital Clinico Universitario Virgen de la Victoria — Málaga, Andalusia
Hospital Universitari Vall d Hebron — Barcelona, Catalonia
Hospital Clinico Universitario de Valencia — Valencia, Valencia
Hospital Universitario Ramon y Cajal — Madrid,
Hospital Universitario 12 de Octubre — Madrid,
Kantonsspital Sankt Gallen — Sankt Gallen,
Adana Sehir Egitim ve Arastirma Hastanesi — Adana,

📞 Contact the Study Coordinator

Phone: (866) 572-6436

Email: medinfo@amgen.com

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.

More studies in Small Cell Lung Cancer

Explore by condition: All Small Cell Lung Cancer clinical trials

💡 How to Participate

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

🏛️ View Official NIH Record ↗