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Not yet recruiting NCT07377916

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

No phase Interventional Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-A1811.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Single-Arm, Exploratory Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced Non-Small Cell Lung Cancer

Overview

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.

Detailed description

Patients who meet the following criteria are enrolled:

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 Received SHR-A1811 combined with pertuzumab

Interventions

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

Primary outcome measures

  • Progression Free Survival (PFS) by investigator assessment [Time frame: Until progression, assessed up to approximately 2 years]
Secondary outcome measures (5)
  • Objective Response Rate （ORR） [Time frame: Two years after the last subject was enrolled in the group]
  • Overall Survival (OS) [Time frame: Until death, assessed up to approximately 3 years]
  • Disease Control Rate (DCR) [Time frame: Two years after the last subject was enrolled in the group]
  • Duration of Response (DOR) [Time frame: Two years after the last subject was enrolled in the group]
  • AE [Time frame: until to 90 days after the last dose，assessed up to approximately 3 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07377916 · ES-2025-235-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗