At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- PF-08046054 (drug), Docetaxel monotherapy (drug)
- How long the study runs
- Study runs about 78 months (dates as stated)
- About the drug or intervention
- PF-08046054 — drug: Antibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion. · Docetaxel monotherapy — drug: Participants will receive Docetaxel, administered as an IV infusion.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 680
- Started
- 2025-09-29
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell carcinoma
- • Phase3 - 680 participants
- • The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell carcinoma
Where?
- • London - St Bartholomew's Hospital
- • London - Sarah Cannon Research Institute UK
- • London - Barts Health NHS Trust , The Royal London Hospital
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation. Participants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives
What the study is looking for
- ✓Inclusion Criteria
- ✓PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the...
- ✓Participants who have NSCLC with known AGAs are permitted.
- ✓Able to provide any of the following tumor tissues for test result analysis:
- ✓Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual...
See the full criteria
Where Is This Study? (4 UK sites)
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
Sarah Cannon Research Institute UK
London w1g 6ad, United Kingdom
Barts Health NHS Trust , The Royal London Hospital
London E1 1FR, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
Sponsor contactCONTACT
