NCT07524452

Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

A Phase III Study of Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma： a Multicenter, Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: Ming-Yuan Chen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, open-label, multicenter phase III trial designed to systematically evaluate the efficacy and safety of perioperative neoadjuvant and adjuvant therapy with Becotatug vedotin in combination with PD-1 inhibitor versus PD-1 inhibitor alone in patients with EGFR-positive, CPS ≥ 1 resectable locally advanced head and neck squamous cell carcinoma .

Conditions

• Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Neoadjuvant and Adjuvant Becotatug Vedotin	Neoadjuvant therapy with Becotatug Vedotin (Day 1, Q3W, 2 cycles); Adjuvant therapy after radiotherapy with Becotatug Vedotin ( Day 1, Q3W, for a total of 12 cycles).
DRUG	Neoadjuvant and Adjuvant Immunotherapy	Neoadjuvant immunotherapy with pucotenlimab (200mg, Day 1, Q3W, 2 cycles); Adjuvant immunotherapy duiring and after radiotherapy with pucotenlimab (200mg, Day 1, Q3W, for a total of 15 cycles).
PROCEDURE	Surgery	Radical surgery performed 3-4 weeks after neoadjuvant therapy, following a re-evaluation of surgical indications by the surgeon.
RADIATION	Adjuvant Radiotherapy	Radiotherapy is initiated 4-6 weeks after surgery. For the low-risk group, a total dose of 60 Gy in 30 fractions is delivered using intensity-modulated radiation therapy (IMRT). For the high-risk group, 66 Gy in 33 fractions is prescribed, or 70 Gy in 35 fractions for residual lesions, also using IMRT.
DRUG	Adjuvant Cisplatin	High-risk group：Cisplatin 100 mg/m² is administered via intravenous infusion on Day 1 of every 21-day cycle during radiotherapy, for a total of 3 cycles.

Timeline

• Start date: 2026-02-06
• Primary completion: 2031-02-28
• Completion: 2032-02-28
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: China