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PF-08046054

Phase 3

Non-small Cell Carcinoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Apr 21, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment680
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07144280A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)PHASE3 RECRUITING 680Sep 29, 2025Mar 10, 2032Apr 21, 2026305 United States, Argentina +26
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Study Endpoints
Primary Endpoints
Overall Survival
Approximately 5 years

Overall survival defined as the time from the date of randomization to the date of death due to any cause.

Secondary Endpoints
Progression Free Survival (PFS) assessed by blinded independent central review (BICR)
Approximately 5 years
Objective Response Rate as assessed by BICR
Approximately 5 years
Progression Free Survival as assessed by Investigator
Approximately 5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-08046054 monotherapyEXPERIMENTALPF-08046054 monotherapy
Docetaxel monotherapyACTIVE_COMPARATORDocetaxel monotherapy
Interventions
NameTypeDescription
PF-08046054DRUGAntibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion.
Docetaxel monotherapyDRUGParticipants will receive Docetaxel, administered as an IV infusion.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites305

Inclusion Criteria * Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual,...

Countries:United StatesArgentinaAustraliaBelgiumBulgariaCanadaChinaCzechiaDenmarkFinlandFranceGermanyGreeceIndiaIsraelItalyJapanMexicoNetherlandsPolandPuerto RicoSlovakiaSouth AfricaSouth KoreaSpainSwedenTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07144280primaryCompletionDate: changed
LOWMay 24, 2026NCT07144280studyFirstPostDate: changed