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ZL-1310

Phase 1

Small Cell Lung Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

ZL-1310 · 1 trial · 1 indication

Phase 1 1
NCT07531095Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)Small Cell Lung Cancer
RECRUITING160 Analytics
PHASE1RECRUITING
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Up to 3.5 years
Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Up to Day 21

Secondary Endpoints

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Up to 3.5 years
Duration of Response (DOR) per RECIST v1.1
Up to 3.5 years
Time to Response (TTR) per RECIST v1.1
Up to 3.5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Exploration (Part 1)EXPERIMENTALMultiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV).
Dose Expansion (Part 2)EXPERIMENTALZL-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.
Triplet Combination (Part 3)EXPERIMENTALZL-1310 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV.

Interventions

NameTypeDescription
ZL-1310DRUGZL-1310 will be administered as an IV infusion.
TarlatamabDRUGTarlatamab will be administered as an IV infusion.
DurvalumabDRUGDurvalumab will be administered as an IV infusion.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * 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 ...

Countries:United StatesAustraliaBelgiumFranceGermanyPolandSpainSwitzerlandTurkey (Türkiye)
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Small Cell Lung Cancer")

Recent Changes (Last 90 Days)

LOWAug 21, 2026NCT07531095lastUpdatePostDate: changed
LOWAug 21, 2026NCT07531095lastUpdatePostDate: changed
LOWAug 7, 2026NCT07531095lastUpdatePostDate: changed
LOWAug 7, 2026NCT07531095lastUpdatePostDate: changed
LOWAug 3, 2026NCT07531095lastUpdatePostDate: changed
LOWAug 3, 2026NCT07531095lastUpdatePostDate: changed

Frequently asked questions about ZL-1310

What is ZL-1310 used for in Small Cell Lung Cancer?

ZL-1310 is an investigational small molecule being studied for the treatment of Small Cell Lung Cancer (SCLC). It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated in combination with other therapies to assess its safety and efficacy in patients with this disease.

Who makes ZL-1310?

ZL-1310 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting a Phase 1 clinical trial to evaluate the drug in patients with Small Cell Lung Cancer.

What phase is ZL-1310 in?

ZL-1310 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is recruiting participants to study the drug's safety, tolerability, and preliminary efficacy in Small Cell Lung Cancer.

What clinical trials is ZL-1310 in?

ZL-1310 is being studied in a Phase 1 clinical trial with the identifier NCT07531095. This trial is titled 'Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)' and is currently recruiting participants. The trial is enrolling approximately 160 patients across multiple countries, including the United States, Australia, and several European nations.

Is ZL-1310 the same as tarlatamab?

No, ZL-1310 is not the same as tarlatamab. ZL-1310 is a separate investigational small molecule being developed by Amgen. In the ongoing Phase 1 clinical trial, ZL-1310 is being studied in combination with tarlatamab, with or without an anti-PD-L1 agent, for the treatment of Small Cell Lung Cancer.