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

ConditionNon-Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A1811

    Drug

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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: SHR-A1811 combined with pertuzumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS) by investigator assessment

Time frame
Until progression, assessed up to approximately 2 years

Secondary outcomes

1

Objective Response Rate （ORR）

Time frame
Two years after the last subject was enrolled in the group
2

Overall Survival (OS)

Time frame
Until death, assessed up to approximately 3 years
3

Disease Control Rate (DCR)

Time frame
Two years after the last subject was enrolled in the group
4

Duration of Response (DOR)

Time frame
Two years after the last subject was enrolled in the group

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Maoming People's Hospital

Collaborator

Peking University Shenzhen Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: