OncoMatch/Clinical Trials/NCT06758401
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.
Is NCT06758401 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Sigvotatug Vedotin and Pembrolizumab for non-small cell lung cancer.
Treatment: Sigvotatug Vedotin · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR wild-type
documented negative test results for EGFR ... AGAs
Required: ALK wild-type
documented negative test results for ... ALK ... AGAs
Required: ROS1 wild-type
documented negative test results for ... ROS1 AGAs
Required: NTRK1 wild-type
no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies
Required: NTRK2 wild-type
no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies
Required: NTRK3 wild-type
no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies
Required: BRAF wild-type
no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies
Required: RET wild-type
no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies
Required: MET wild-type
no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies
Required: PD-L1 (CD274) overexpression (TPS ≥50%)
Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
WHO 0–1
Prior therapy
Cannot have received: MMAE-derived drug
Any prior treatment with MMAE-derived drugs or IB6 targeting agents.
Cannot have received: IB6 targeting agent
Any prior treatment with MMAE-derived drugs or IB6 targeting agents.
Cannot have received: systemic therapy
Exception: 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.
Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.
Cannot have received: immune-oncology agent directed to a stimulatory or co-inhibitory T-cell receptor
Any prior therapy with an immune-oncology agent directed to a stimulatory or co-inhibitory T-cell receptor
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center · Fullerton, California
- Providence St. Jude Medical Center · Fullerton, California
- St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test) · Fullerton, California
- Intermountain Health Lutheran Hospital · Golden, Colorado
- lntermountain Health Cancer Center at Lutheran · Golden, Colorado
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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