Skip to content

C5851005 -A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE 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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521281-97-00
Acronym
C5851005
Enrollment
246
Registered
2025-11-17
Start date
2025-12-02
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Brief summary

Overall survival (OS)

Detailed description

Confirmed ORR using RECIST v1.1 as assessed by BICR, PFS using RECIST v1.1 as assessed by investigator, Confirmed ORR using RECIST v1.1 as assessed by investigator, DOR using RECIST v1.1 as assessed by BICR, DOR using RECIST v1.1 as assessed by investigator, Type, incidence, severity, seriousness, and relatedness of adverse events (AEs), Mean scores and change from baseline in the global health status/QoL score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Mean scores and change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30, Mean scores and change from baseline in dyspnea, cough, and chest pain scores on the EORTC Quality of Life Cancer Questionnaire – Lung Cancer 13 QLQ-LC13, TTdD in the global health status/QoL score on the EORTC QLQ-C30, TTdD in physical functioning and role functioning scores on the EORTC QLQ-C30, TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13, Plasma concentration at end of infusion and plasma predose concentration for antibody conjugated monomethyl auristatin E (ac-MMAE) and unconjugated monomethyl auristatin E (MMAE) (in PF-08046054 treatment arm only), Incidence of ADA (in PF-08046054 treatment arm only), PFS using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by BICR

Interventions

DRUGDOCETAXEL

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall survival (OS)

Secondary

MeasureTime frame
Confirmed ORR using RECIST v1.1 as assessed by BICR, PFS using RECIST v1.1 as assessed by investigator, Confirmed ORR using RECIST v1.1 as assessed by investigator, DOR using RECIST v1.1 as assessed by BICR, DOR using RECIST v1.1 as assessed by investigator, Type, incidence, severity, seriousness, and relatedness of adverse events (AEs), Mean scores and change from baseline in the global health status/QoL score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Mean scores and change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30, Mean scores and change from baseline in dyspnea, cough, and chest pain scores on the EORTC Quality of Life Cancer Questionnaire – Lung Cancer 13 QLQ-LC13, TTdD in the global health status/QoL score on the EORTC QLQ-C30, TTdD in physical functioning and role functioning scores on the EORTC QLQ-C30, TTdD in the dyspnea, cough, and chest pain scores on t

Countries

Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Poland, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026