Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC

NCT07377916 | Not Yet Recruiting

• 1 other identifier: ES-2025-235-02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study enrolled patients with advanced or metastatic NSCLC harboring HER2 mutations, amplification, or overexpression who had progressed after ≥1 prior lines of anticancer therapy. After enrollment, participants received treatment with rezetamab plus pertuzumab until disease progression, intolerable toxicity, withdrawal of consent, or other conditions requiring treatment discontinuation.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) by investigator assessment

  Until progression, assessed up to approximately 2 years

Secondary Outcomes (5)

• Objective Response Rate （ORR）

  Two years after the last subject was enrolled in the group

• Overall Survival (OS)

  Until death, assessed up to approximately 3 years

• Disease Control Rate (DCR)

  Two years after the last subject was enrolled in the group

• Duration of Response (DOR)

  Two years after the last subject was enrolled in the group

• AE

  until to 90 days after the last dose，assessed up to approximately 3 years

Study Arms (1)

SHR-A1811 combined with pertuzumab

EXPERIMENTAL

Intravenous infusion，Q3 week, SHR-A1811 combined with pertuzumab

Drug: SHR-A1811

Interventions

SHR-A1811 DRUG

Intravenous infusion, q3 week, SHR-A1811 combined with pertuzumab

SHR-A1811 combined with pertuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years
• Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition)
• Pathologically documented HER2 mutation, amplification, or overexpression
• Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease
• There is at least one measurable lesion according to RECIST V1.1 criteria
• ECOG score of 0 or 1.
• The expected survival is ≥12 weeks

You may not qualify if:

• There are untreated or active central nervous system (CNS) tumor metastases
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
• Pleural, ascites, or pericardial effusion requiring intervention occurred within 14 days prior to initial administration
• Systemic antitumor therapy was performed 4 weeks prior to study initiation
• Subjects who have previously received HER2-targeted therapy (excluding pan-HER tyrosine kinase inhibitors) or antibody-drug conjugates with a topoisomerase I inhibitor payload.
• Use of strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within less than 5 drug half-lives prior to the first dose.
• Has active infection requiring systemic treatment.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead
• Maoming People's Hospital: collaborator
• Peking University Shenzhen Hospital: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Wenhua Liang

CONTACT

13710249454; 550627660@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guangzhou Medical University Affiliated First Hospital National Respiratory Research Center

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 30, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share