MedTrace Logo

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

NCT07524452 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2026-04-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ming-Yuan Chen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2031-02-28
Completion
2032-02-28

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07524452 on ClinicalTrials.gov