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
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Enrollment
- 60
- Primary Endpoint
- Progression Free Survival (PFS) by investigator assessment
Overview
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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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 ≤
- •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.
Arms & Interventions
SHR-A1811 combined with pertuzumab
Intravenous infusion，Q3 week, SHR-A1811 combined with pertuzumab
Intervention: SHR-A1811 (Drug)
Outcomes
Primary Outcomes
Progression Free Survival (PFS) by investigator assessment
Time Frame: Until progression, assessed up to approximately 2 years
Secondary Outcomes
- 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)
Investigators
Jianxing He
Guangzhou Medical University Affiliated First Hospital National Respiratory Research Center
The First Affiliated Hospital of Guangzhou Medical University