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LY2875358

Phase 2

Carcinoma, Non-Small-Cell Lung | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Jan 26, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment168
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01897480A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor MutationsPHASE2 COMPLETED 168 — — Aug 28, 2013Jan 8, 2026Jan 26, 202645 Denmark, France +7
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Study Endpoints
Primary Endpoints
Progression Free Survival (PFS)
Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
Secondary Endpoints
Change in Tumor Size (CTS)
Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years)
Proportion of Participants Exhibiting a Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Estimated 3 Years)
Duration of Response (DoR)
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY2875358 plus ErlotinibEXPERIMENTALLead In: Approximately 8 weeks of erlotinib 150 milligram (mg) given orally per day. Randomization: Erlotinib 150 mg given orally per day plus 750 mg LY2875358 given as 1.5 hours intravenous (IV) infusions on Days 1 and 15 of 28-day cycles.
ErlotinibACTIVE_COMPARATORLead In: Approximately 8 weeks of erlotinib 150 mg given orally per day. Randomization: Continue Erlotinib 150 mg given orally per day, in 28-day cycles.
Interventions
NameTypeDescription
LY2875358BIOLOGICALAdministered IV
ErlotinibDRUGAdministered Orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites45

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC * Have at least 1 measurable lesion whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) * Have molecular evidence of an epid...

Countries:DenmarkFranceGermanyItalyNetherlandsSouth KoreaSpainTaiwanUnited Kingdom
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