NCT06758401: Be6A Lung-02

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.

Recruiting now Phase 3 Last updated 7 April 2026

What this trial tests

Phase 3 trial testing Sigvotatug Vedotin in Non-Small Cell Lung Cancer in 714 participants. Currently enrolling.

Timeline

23 July 2025

Primary endpoint
5 September 2028

1 March 2029

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	714
Start date	23 July 2025
Primary completion	5 September 2028
Estimated completion	1 March 2029
Sites	330 locations across Italy, Japan, Taiwan, Poland, South Korea, Netherlands, Belgium, Mexico

Drugs / interventions tested

• Sigvotatug Vedotin (sigvotatug-vedotin) — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
• Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →
• Carcinoma, Non-Small-Cell Lung (NSCLC) — all drugs for Carcinoma, Non-Small-Cell Lung (NSCLC) →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer or Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibody-Drug Conjugates (ADCs): current and future biopharmaceuticals.
   Wang R, Hu B, Pan Z, Mo C, et al · · 2025 · cited 105× · PMID 40307936 · DOI 10.1186/s13045-025-01704-3
2. Antibody-drug conjugates in cancer therapy: current advances and prospects for breakthroughs.
   Wu D, Yang K, He R, Yin R, et al · · 2025 · cited 2× · PMID 41133214 · DOI 10.3389/fcell.2025.1669592
3. Antibody drugs conjugates in non-small cell lung cancer: current status and challenges.
   Syal A, Meyer ML, Angelino K, Osei N, et al · · 2025 · cited 1× · PMID 41052301 · DOI 10.1093/oncolo/oyaf331
4. Overcoming resistance to antibody-drug conjugates: mechanisms and emerging strategies.
   Inase A, Kimbara S, Imamura E, Phelps MA, et al · · 2026 · PMID 41630503 · DOI 10.1093/oncolo/oyag020
5. Frontline sigvotatug vedotin plus pembrolizumab vs pembrolizumab for non-small cell lung cancer with PD-L1 tumor proportion score ≥50%: phase III study design.
   Reck M, Lu S, O'Byrne KJ, Barrios C, et al · · 2025 · PMID 41388832 · DOI 10.1080/14796694.2025.2596228