A Phase 1 interventional study of ZL-1310 and Tarlatamab in Small Cell Lung Cancer, sponsored by Amgen. Recruiting at 27 sites in 9 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
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.
1,201 studies on the registry are indexed under Small Cell Lung Carcinoma; 340 are open to participants now.
This study's planned enrollment of 160 is above the median of 56 across 1,030 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted.
Exclusion Criteria:
Multiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV).
Drug: ZL-1310 · Drug: Tarlatamab
ZL-1310 will be administered IV at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV.
Drug: ZL-1310 · Drug: Tarlatamab
ZL-1310 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV.
Drug: ZL-1310 · Drug: Tarlatamab · Drug: Durvalumab
ZL-1310 will be administered as an IV infusion.
Tarlatamab will be administered as an IV infusion.
Also known as: IMDELLTRA
Durvalumab will be administered as an IV infusion.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 3.5 years
Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time frame: Up to Day 21
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Up to 3.5 years
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to 3.5 years
Time to Response (TTR) per RECIST v1.1
Time frame: Up to 3.5 years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to 3.5 years
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to 3.5 years
Time to Progression (TTP) per RECIST v1.1
Time frame: Up to 3.5 years
Time to Subsequent Therapy
Time frame: Up to 3.5 years
Overall survival (OS)
Time frame: Up to 3.5 years
Serum Tarlatamab Concentrations
Time frame: Up to Week 36
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amgen