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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.

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started2025-07-23
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
minor
Trial sites expanded: 372 → 389 locations
2026-07-21
minor
Study Status, Contacts/Locations v17
Trial sites expanded: 329 → 372 locations
2026-04-17
minor
Study Status, Contacts/Locations v16
Study sites330→329
2026-04-06
minor
Study Status, Contacts/Locations v15
Trial sites expanded: 315 → 330 locations
2026-03-11
minor
Study Status, Contacts/Locations v14
Study sites296→315
Show 13 earlier versions
2026-02-12
minor
Study Status, Contacts/Locations v13
Study sites241→296
2025-12-11
minor
Study Status, Contacts/Locations v12
Study sites152→241
2025-10-08
minor
Study Status, Contacts/Locations v11
Study sites106→152
2025-09-08
minor
Study Status, Contacts/Locations v10
Study sites62→106
2025-08-18
minor
Study Identification, Study Status, Contacts/Locations v9
Start date2025-05-04→2025-07-23
Study sites46→62
2025-07-30
minor
Study Status, Contacts/Locations v8
Study sites22→46
2025-07-09
minor
Study Status v7
Re-verified, no change to tracked fields
2025-07-07
minor
Study Status, Contacts/Locations v6
Study sites7→22
2025-06-10
minor
Study Status, Contacts/Locations v5
Study sites3→7
2025-05-09
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-05-31→confirmed 2025-05-04
Study sites0→3
Eligibility criteria+38 characters
[...] ith approved front-line therapies per local standard of care Must not have small cell elements present. Large cell neuroendocrine carcinoma is excluded. Candidate [...] n metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter <0.5 cm are permitted. Major surgery (defined as a surgery requiring inpatient hosp [...]
2025-04-15
minor
Study Status v3
Re-verified, no change to tracked fields
2025-03-14
minor
Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations v2
Study sites5→0
Eligibility criteria+58 characters
[...] (Version 8.0) and the UICC Staging System (Eighth edition). DocumentedParticipants with non-squamous histology must have documented negative test results for EGFR, ALK, and ROS1. No AGAs and no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies per local standard of care. Must not have small cell elements present. Large cell neuro [...]
2025-03-07
minor
Study Identification, Study Status, Arms and Interventions, Contacts/Locations v1
Primary completion date2028-08-24→2028-09-05
Completion date2029-02-17→2029-03-01
Start date2025-01-20→2025-05-31
Study sites0→5
2024-12-26
minor
Original filing
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.
Trial Details
NCT Number NCT06758401
Lead Sponsor Pfizer
Conditions Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC)
Enrollment 714 participants
Start Date 2025-07-23
Primary Completion 2028-09-05 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-25