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.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Non-Small-Cell Lung (NSCLC)
• Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sigvotatug Vedotin — DRUG
  MMAE-Antibody Drug Conjugate targeting Integrin Beta-6
• Pembrolizumab — DRUG
  Anti-PD-(L)1

Study Details

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.

Key Dates

Start date

Jul 23, 2025

Status verified

Apr 2026

Primary completion

Sep 5, 2028

Completion

Mar 1, 2029

Study Design

Enrollment

714 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sigvotatug Vedotin with Pembrolizumab
  Participants will receive Sigvotatug Vedotin, administered as an IV infusion and pembrolizumab, administered as an IV infusion.
• Active Comparator: Pembrolizumab Monotherapy
  Participants will receive pembrolizumab, administered as an IV infusion.

Primary Outcome Measure

Overall Survival [ Time Frame: Baseline to date of death from any cause (Approximately 2 years) ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (58)

Find similar trials in Fullerton, CA

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