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Lerotinib

Phase 3

Esophageal Cancer | Small molecule | Oncology |Sunshine Biopharma Inc.|Last Updated: Aug 24, 2026

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 106 trials

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Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT04415853lastUpdatePostDate: changed
LOWAug 28, 2026NCT04415853lastUpdatePostDate: changed
LOWAug 28, 2026NCT04415853lastUpdatePostDate: changed
LOWAug 28, 2026NCT04415853lastUpdatePostDate: changed
LOWJul 5, 2026NCT04415853primaryCompletionDate: changed
LOWJul 5, 2026NCT04415853primaryCompletionDate: changed
LOWJul 5, 2026NCT04415853primaryCompletionDate: changed

Frequently asked questions about Lerotinib

What is Lerotinib used for?

Lerotinib is an investigational small molecule being developed for the treatment of esophageal cancer, specifically unresectable advanced or recurrent esophageal cancer. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

What does Lerotinib target?

Lerotinib is a kinase inhibitor, as indicated by its '-tinib' suffix, which means it works by inhibiting kinase enzymes involved in cancer cell signaling and growth. The specific molecular target has not been disclosed in available information.

Who makes Lerotinib?

Lerotinib is being developed by Sunshine Biopharma Inc., a company traded on the stock market under the ticker symbol SBFM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with esophageal cancer.

What phase is Lerotinib in?

Lerotinib is currently in Phase 3 clinical development. It is being studied in an active, recruiting clinical trial for unresectable advanced or recurrent esophageal cancer, with a planned enrollment of 416 participants in China.

What clinical trials is Lerotinib in?

Lerotinib is being evaluated in a Phase 3 clinical trial with the identifier NCT04415853, titled 'Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer.' The trial is recruiting patients aged 18 years and older in China and is actively enrolling participants.

Is Lerotinib the same as Larotinib?

Yes, Lerotinib is also known as Larotinib. The clinical trial NCT04415853 uses the name Larotinib to refer to the same drug being developed by Sunshine Biopharma for the treatment of esophageal cancer.