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ZL-1310

Phase 1

Small Cell Lung Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: May 29, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07531095Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)PHASE1 RECRUITING 160Apr 21, 2026May 21, 2031May 29, 20266 United States, Turkey (Türkiye)
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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 — 99 Years
SexALL
Healthy VolunteersNo
Study Sites6

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 StatesTurkey (Türkiye)
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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel, ABP 234, Pembrolizumab, Sotorasib
AstraZeneca PLCAZN63PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel, RMC-6291, Elironrasib, Daraxonrasib
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab
Bristol-Myers Squibb CompanyBMY20PHASE3Repotrectinib, Crizotinib, Nivolumab, Carboplatin, Cisplatin
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel, PM8002, Carboplatin, Pemetrexed
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel, Zimberelimab, Domvanalimab, Pembrolizumab
GSK plc Sponsored ADRGSK4PHASE3Cobolimab, Dostarlimab, Docetaxel, Belrestotug, Pembrolizumab
Johnson & JohnsonJNJ18PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin, Osimertinib
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib, Drug: Furmonertinib, Furmonertinib, JAB-21822, JAB 21822
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel, TNO155, tislelizumab, DKY709
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07531095lastUpdatePostDate: changed
LOWMay 29, 2026NCT07531095lastUpdatePostDate: changed
LOWMay 29, 2026NCT07531095lastUpdatePostDate: changed
LOWMay 26, 2026NCT07531095lastUpdatePostDate: changed
LOWMay 24, 2026NCT07531095studyFirstPostDate: changed
LOWMay 21, 2026NCT07531095NEW_TRIAL: changed
LOWMay 21, 2026NCT07531095NEW_TRIAL: changed