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Lerotinib

Phase 3

Esophageal Cancer | Small molecule | Oncology |Sunshine Biopharma Inc.|Last Updated: May 18, 2025

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment416
FDA Designations
No designations recorded
Clinical trial landscape

Lerotinib · 1 trial · 1 indication

Phase 3 1
NCT04415853Study of Larotinib in Unresectable Advanced or Recurrent Esophageal CancerEsophageal Cancer
RECRUITING416 Analytics
PHASE3RECRUITING
Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
Esophageal CancerUnlock trial analytics
Study Endpoints
Primary Endpoints
Overall survival
up to approximately 22 months

Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.

Secondary Endpoints
Progression-free survival
up to approximately 22 months
Objective response rate
up to approximately 22 months
Duration of response
up to approximately 22 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Lerotinib ArmEXPERIMENTAL350 mg,qd, orally about half an hour after a meal, continuous administration, every 21 days for a treatment cycle.
Active Comparator ArmACTIVE_COMPARATORIrinotecan: Intravenously administered at a dose of 180 mg/m2 every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Tegafur: 40-60mg po bid(d1-d14),every 21 days as a cycle, continuous drug administration from 1 to 14 days of each cycle, and then stopped 7 days.
Interventions
NameTypeDescription
LerotinibDRUGSpecification: 50 mg/capsule and 150 mg/capsule
Irinotecan/TegafurDRUGIrinotecan:Specification: 2mL: 40mg;5mL:0.1g Tegafur:20mg/capsule
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Eligibility Criteria
Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age:18-75 years, male or female. 2. Histologically or cytologically confirmed squamous cell carcinoma of the esophagus or advanced/metastatic disease. 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy of greater than 3 months...

Countries:China
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Competitive Landscape -Esophageal Cancer 109 trials
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Recent Changes (Last 90 Days)
LOWJul 5, 2026NCT04415853primaryCompletionDate: changed
LOWJul 5, 2026NCT04415853primaryCompletionDate: changed
LOWJul 5, 2026NCT04415853primaryCompletionDate: changed
LOWMay 24, 2026NCT04415853studyFirstPostDate: changed