Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2… (NCT07377916) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC
60 participantsStarted 2026-02-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Progression Free Survival (PFS) by investigator assessment
Timeframe: Until progression, assessed up to approximately 2 years
Trial details
NCT IDNCT07377916
SponsorThe First Affiliated Hospital of Guangzhou Medical University