Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.

Sponsor: Pfizer

NCT ID: NCT06758401

View on ClinicalTrials.gov ↗

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.

Non-Small Cell Lung CancerCarcinoma, Non-Small-Cell LungCarcinoma, Non-Small-Cell Lung (NSCLC)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

EGFRALKROS1NTRKBRAFRETMETDocumented negative

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
Inclusion Criteria: 1. Participants must meet the following criteria: 1. Have pathologically confirmed Stage IIIB or IIIC NSCLC and not be a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC per the AJCC Staging Manual (Version 8.0) and the UICC Staging System (Eighth edition). 2. Participants with known AGAs including EGFR, ALK, ROS1, NTRK, BRAF, RET, and MET, for which there are approved and available first-line therapies per local SOC are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology. 3. Participants with large cell neuroendocrine carcinoma are excluded. 4. Must be an appropriate candidate for treatment with pembrolizumab monotherapy per local guidelines. 2. Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing. 3. Measurable disease based on RECIST v1.1 per investigator. 4. Resolution of acute effects of any prior therapy to either baseline severity or NCI CTCAE Grade 1 or less (except for AEs not constituting a safety risk in the investigator's judgment), unless otherwise excluded. Exclusion Criteria: 1. Life expectancy of \<3 months in the opinion of the investigator. 2. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study. 3. Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. 4. Known or suspected hypersensitivity, intolerance, or contraindication to any excipient contained in the drug formulation of sigvotatug vedotin or pembrolizumab. 5. Participants with any of the following respiratory conditions: 1. Evidence of noninfectious or drug-induced ILD or pneumonitis 2. Known DLCO (adjusted for hemoglobin) \<50% predicted. 3. Grade ≥3 pulmonary disease unrelated to underlying malignancy 6. Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Up to 5 clinically asymptomatic brain metastases of longest diameter \<1.0 cm are permitted without definitive surgery and/or radiotherapy. 7. Major surgery (defined as a surgery requiring inpatient hospitalization of at least 48 hours) within 21 days or minor surgery (excluding peripherally inserted central catheter placement and implantable central venous port placement) within 3 days prior to first dose of study intervention. 8. Receipt of a live vaccine within 30 days prior to first dose of study intervention. 9. Pre-existing peripheral neuropathy Grade ≥2 per NCI CTCAE v5.0. 10. Uncontrolled diabetes mellitus, defined as HbA1c ≥8.0% or HbA1c between 7.0% and 8.0% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained. 11. Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, required a high-dose steroid taper (≥0.5 mg/kg prednisone or equivalent per day) for \>2 weeks, or required treatment with systemic immunosuppressive therapy. 12. History of autoimmune disease that has required systemic treatment in the past 2 years 13. Participants with prior solid organ or bone marrow transplantation. 14. Currently receiving a high-dose steroid (\>10 mg prednisone or equivalent per day) or other immune suppressant or has a condition requiring a chronic high-dose steroid or immune suppressant. 15. Prior and concomitant therapy: 1. Any prior treatment with MMAE-derived drugs or IB6 targeting agents. 2. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC. * (Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose. * Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose. 3. Prior radiotherapy to the lung within 6 months of first dose of study intervention, referencing the last date radiotherapy was received. This includes both curative and palliative radiotherapy. 4. Chemotherapy, biologics, and/or other antitumor treatment with immunotherapy not specifically prohibited that is completed less than 4 weeks prior to first dose of study intervention, or 2 weeks for palliative radiotherapy. 5. Any prior therapy with an immune-oncology agent directed to a stimulatory or co-inhibitory T-cell receptor 16. History of or current ongoing infection, including participants positive for active HIV, HBV, or HCV. 17. Severe uncontrolled cardiac or cerebrovascular condition within the previous 6 months

Where Is This Study? (9 UK sites)

Royal Cornwall Hospitals NHS Trust

Truro TR1 3LJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Abi Weeks

rch-tr.CornwallResearch@nhs.net01872 25 6424

Weston Park Hospital

Sheffield S10 2SJ, United Kingdom

NOT_YET_RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton SO16 6YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Mount Vernon Hospital

Northwood HA6 2RN, United Kingdom

NOT_YET_RECRUITING

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting

Musgrove Park Hospital

Taunton TA1 5DA, United Kingdom

NOT_YET_RECRUITING

Ipswich Hospital

Ipswich IP4 5PD, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Frances Farnworth

R&D@esneft.nhs.uk01473 704787

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Royal Berkshire Hospital

Reading RG1 5AN, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Leslie Frederick-Mokogwu

researchanddevelopment@royalberkshire.nhs.uk0118 322 7449

How to Get in Touch

Pfizer CT.gov Call Center

Sponsor contact

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09