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PF-08046054

Phase 3

Non-small Cell Carcinoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jul 22, 2026

Target and mechanism

Molecular targetPD-L1
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment680

FDA Designations

No designations recorded

Clinical trial landscape

PF-08046054 · 2 trials · 11 indications

Phase 3 1Phase 1 1
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)Non-small Cell Carcinoma
RECRUITING680 Analytics
PHASE3RECRUITING
A 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)
Non-small Cell CarcinomaUnlock trial analytics

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.

Number of participants with adverse events (AEs)
Through approximately 90 days after last study treatment; up to 3 years

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Number of participants with laboratory abnormalities
Through approximately 90 days after last study treatment; up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
Through the first cycle of study treatment; approximately 1 month
Number of participants with DLTs by dose level
Through the first cycle of study treatment; approximately 1 month

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
PF-08046054 Combination TherapyEXPERIMENTALPF-08046054 + pembrolizumab

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.
pembrolizumabDRUG200 mg once every 3 weeks given into the vein (IV; intravenously)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites402

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 StatesArgentinaAustraliaBelgiumBrazilBulgariaCanadaChinaCzechiaDenmarkFinlandFranceGermanyGreeceIndiaIsraelItalyJapanMexicoNetherlandsPolandPuerto RicoSlovakiaSouth AfricaSouth KoreaSpainSwedenTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 22, 2026NCT05208762lastUpdatePostDate: changed
LOWJul 22, 2026NCT07144280lastUpdatePostDate: changed
LOWJul 22, 2026NCT05208762lastUpdatePostDate: changed
LOWJul 22, 2026NCT07144280lastUpdatePostDate: changed
LOWMay 26, 2026NCT05208762primaryCompletionDate: changed
LOWMay 26, 2026NCT07144280primaryCompletionDate: changed
LOWMay 24, 2026NCT05208762studyFirstPostDate: changed
LOWMay 24, 2026NCT07144280studyFirstPostDate: changed

Frequently asked questions about PF-08046054

What is PF-08046054 used for?

PF-08046054 is an investigational small molecule being developed for oncology indications, including non-small-cell lung cancer, squamous cell carcinoma of the head and neck, esophageal squamous cell carcinoma, triple negative breast neoplasms, gastric cancer, endometrial cancer, pancreatic adenocarcinoma, and hepatocellular carcinoma. It is currently in Phase 1 clinical development.

What does PF-08046054 target?

PF-08046054 targets PD-L1, a protein involved in immune checkpoint regulation. By targeting PD-L1, the drug is designed to modulate the immune response against cancer cells. This mechanism is being studied in the context of advanced solid tumors, including non-small-cell lung cancer.

Who makes PF-08046054?

PF-08046054 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials for multiple oncology indications.

What phase is PF-08046054 in?

PF-08046054 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is studying the drug in advanced solid tumors, with additional trials planned for later phases.

What clinical trials is PF-08046054 in?

PF-08046054 is being studied in a Phase 1 trial (NCT05208762) for advanced solid tumors, enrolling 714 participants across multiple countries. A Phase 3 trial (NCT07144280) is also recruiting to compare PF-08046054 versus docetaxel in previously-treated PD-L1 positive non-small-cell lung cancer, with an enrollment target of 680 participants.

Is PF-08046054 the same as SGN-PDL1V?

Yes, PF-08046054 is also known as SGN-PDL1V. Both names refer to the same investigational drug being developed by Pfizer. The Phase 1 and Phase 3 clinical trials listed for PF-08046054 use both names in their official titles, confirming they are the same compound.