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
- Sigvotatug Vedotin (drug), Pembrolizumab (drug)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- Sigvotatug Vedotin — drug: MMAE-Antibody Drug Conjugate targeting Integrin Beta-6 · Pembrolizumab — drug: Anti-PD-(L)1
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 714
- Started
- 2025-07-23
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase3 - 714 participants
- • The purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • Truro - Royal Cornwall Hospitals NHS Trust
- • Sheffield - Weston Park Hospital
- • Southampton - University Hospital Southampton NHS Foundation Trust
- • Northwood - Mount Vernon Hospital
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1. This is a protein that acts as a kind of "brake" to keep the body's immune responses under control. The study is seeking for participants who: * Are confirmed to have NSCLC (Stage 3 or 4). * Have PD-L1 levels in more than 50% of the cancer cells. All participants in this study will receive pembrolizumab at the study clinic once every 6 weeks as an intravenous (IV) infusion (give directly into a vein). In addition, half of the participants will also receive Sigvotatug Vedotin once every 2 weeks as an IV infusion in addition to receiving pembrolizumab. Participants may receive pembrolizumab for up to about two years. Those participants taking Sigvotatug Vedotin can continue until their NSCLC is no longer responding. The study team will monitorsee 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:
- ✓ for participants with non-squamous histology
- ✓ to either baseline severity
What the study is looking for
- ✓Participants must meet the following criteria:
- ✓Participants with large cell neuroendocrine carcinoma are excluded.
- ✓Must be an appropriate candidate for treatment with pembrolizumab monotherapy per local guidelines.
- ✓Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing.
- ✓cancer that can be measured on scans based on (standard scan measurements) per investigator.
Who cannot take part
- ✗Life expectancy of \<3 months in the opinion of the investigator.
- ✗Participants with any history of another cancer within 3 years before the first dose of study intervention, or...
- ✗Known or suspected hypersensitivity, intolerance, or safety concern to any excipient contained in the drug...
- ✗Participants with any of the following respiratory conditions:
- ✗Evidence of noninfectious or drug-induced ILD or pneumonitis
See the full criteria
Where Is This Study? (9 UK sites)
Royal Cornwall Hospitals NHS Trust
Truro TR1 3LJ, United Kingdom
Weston Park Hospital
Sheffield S10 2SJ, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
Mount Vernon Hospital
Northwood HA6 2RN, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
Musgrove Park Hospital
Taunton TA1 5DA, United Kingdom
Ipswich Hospital
Ipswich IP4 5PD, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Royal Berkshire Hospital
Reading RG1 5AN, United Kingdom
Leslie Frederick-Mokogwu
researchanddevelopment@royalberkshire.nhs.uk0118 322 7449How to Get in Touch
Pfizer CT.gov Call Center
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