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Vebreltinib

Phase 2

Non-Small-Cell Lung Cancer | Small molecule | Oncology |China Pharma Holdings, Inc.|Last Updated: Feb 14, 2025

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06827145Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLCPHASE2 ACTIVE NOT_RECRUITING 30Oct 14, 2024Sep 1, 2028Feb 14, 20251 China
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Study Endpoints
Primary Endpoints
Progression-free survival
3 years

From the first treatment to the date of first documentation of disease progression, or death due to any cause

Secondary Endpoints
Overall Response Rate
3 years
Overall survival
5 years
Duration of Response
3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental ArmEXPERIMENTALAll patients received oral Vebreltinib 100mg BID plus Osimertinib 80mg once daily.
Interventions
NameTypeDescription
VebreltinibDRUGVebreltinib 100mg oral BID
OsimertinibDRUGOsimertinib 80mg oral once daily.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 1\. Signed an informed consent form. 2\. Patients aged ≥18. 3\. Histologically or cytologically confirmed locally or metastatic NSCLC. 4.EGFR 21 L858R mutation. 5.at least one measurable lesion according to RECIST 1.1 criteria. 6.ECOG PS 0-1. 7.appropriate or...

Countries:China
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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
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Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
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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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