Table of Contents
- Trial overview
- Phase 3 study in previously treated NSCLC
- Phase 1 study in advanced solid tumors
- What the trials measure
- Who the studies are for
- Key terms explained
Trial overview
Two interventional studies are listed for HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST PD-L1 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A VALINE-CITRULLINE LINKER.[1][2] Both are marked Authorised, which means they have been approved to start.[1][2]
The studies look at different cancer groups and different goals.[1][2] One is a later-stage trial in non-small-cell lung cancer, and the other is an early-stage trial in advanced solid tumors.[1][2]
Phase 3 study in previously treated NSCLC
The first study is a Phase 3 trial in adults with previously treated PD-L1 positive non-small-cell lung cancer (NSCLC).[1] It compares the study medicine, also called PF-08046054/SGNPDL1V, with docetaxel.[1]
This trial includes participants whose tumors have PD-L1 expression of at least 1%, and it also looks at a subgroup with PD-L1 of at least 50%.[1] The main question is whether the study medicine helps people live longer than docetaxel, using overall survival as the primary outcome.[1]
The planned enrollment for this study is 680 people.[1]
Phase 1 study in advanced solid tumors
The second study is a Phase 1 trial in people with advanced solid tumors.[2] It studies HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST PD-L1 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A VALINE-CITRULLINE LINKER together with different anticancer agents, including PF-08634404 and Sigvotatug vedotin.[2]
Phase 1 research often starts with a smaller group to learn about safety and to find a dose that can be studied further.[2] This trial has two parts: a safety run-in, which is an early check of how the treatment is tolerated, and a later part focused on dose optimization and dose expansion.[2]
The planned enrollment for this study is 162 participants.[2]
What the trials measure
The Phase 3 lung cancer study measures overall survival (OS), which means how long participants live after treatment starts.[1]
The Phase 1 study measures several safety and activity outcomes, including adverse events (AEs), dose-limiting toxicities (DLTs), and confirmed objective response rate (ORR) by RECIST v1.1.[2] Adverse events are any unwanted medical problems during the study, and dose-limiting toxicities are side effects that may stop a dose from being increased.[2] Objective response rate shows how many tumors shrink or disappear on scans or exams.[2]
The Phase 1 study also records safety details such as type, frequency, severity, timing, seriousness, and whether the event is related to the study treatment, using NCI CTCAE version 5.0.[2]
Who the studies are for
The Phase 3 study is for adult participants with previously treated PD-L1 positive NSCLC.[1] This means people must already have had treatment before joining the trial.[1]
The Phase 1 study is for people with advanced solid tumors.[2] It is designed for a broader cancer group, not just one cancer type.[2]
Key terms explained
- Interventional study: a trial where participants receive a study treatment so researchers can measure results.[1][2]
- PD-L1: a marker found on some tumors, used here to help select participants for the lung cancer study.[1]
- NSCLC: non-small-cell lung cancer, a common type of lung cancer.[1]
- Docetaxel: the control treatment in the Phase 3 study.[1]
- RECIST v1.1: a standard way to measure whether tumors shrink, stay the same, or grow.[2]
- NCI CTCAE version 5.0: a standard grading system for side effects in cancer trials.[2]
