NCT07531095RecruitingPhase 1
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 9 Apr 2026
- Start date
- 21 Apr 2026
- Primary completion date
- 21 May 2028
- Lead sponsor
- Amgen
- Diseases
- Lung cancer
- NCT number
- NCT07531095
- EU CT number
- 2025-522888-15-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 160
- From 21 Apr 2026 to the primary completion date, 21 May 2028
- 29 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of interstitial lung disease (ILD)/pneumonitis.
Other
- Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.
- Enrollment in any tarlatamab clinical trial.
Who the study is looking for
- 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).
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Kantonsspital Sankt Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| City of Hope Cancer Center Phoenix Coordinator of this site? Confirm its status | Goodyear | United States | Recruiting |
| Baptist Cancer Center Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| New York University Cancer Institute Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Health Partners Cancer Center at Regions Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| City of Hope - Chicago Coordinator of this site? Confirm its status | Zion | United States | Recruiting |
| Adana Sehir Egitim ve Arastirma Hastanesi Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Recruiting |
| Hacettepe Universitesi Tip Fakultesi Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Izmir Ekonomi Universitesi Medical Point Hastanesi Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.