A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country500 target enrollmentNovember 29, 2024

ConditionsNon-small Cell Lung Cancer

InterventionsSHR-A2009 monotherapy platinum-based dual-agent chemotherapy

DrugsSHR-A2009 monotherapy platinum-based dual-agent chemotherapy

Overview

Phase: Phase 3
Intervention: SHR-A2009 monotherapy
Conditions: Non-small Cell Lung Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 500
Locations: 1
Primary Endpoint: Progression-free survival (PFS) assessed by BICR according to RECIST v1.1
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.

Registry

clinicaltrials.gov

Start Date

November 29, 2024

End Date

June 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 to 75 years old (inclusive), Female or male
•Subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology
•Previously treated by EGFR-TKI；
•At least one measurable tumor lesion according to RECIST v1.1
•ECOG performance score of 0-1;
•Expected survival time ≥ 12 weeks;
•Adequate bone marrow and organ function
•Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.

Exclusion Criteria

•Subjects with active central nervous system (CNS) metastases.
•Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
•Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
•Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
•Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
•Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
•Serious cardiovascular disease
•Presence of severe infection within 4 weeks prior to first dose of study drug
•Arterial/venous thrombotic events within 3 months prior to the first study dose
•History of immunodeficiency, including a positive HIV test

Arms & Interventions

SHR-A2009 monotherapy

Intervention: SHR-A2009 monotherapy

platinum-based dual-agent chemotherapy

Intervention: platinum-based dual-agent chemotherapy

Outcomes

Primary Outcomes

Progression-free survival (PFS) assessed by BICR according to RECIST v1.1

Time Frame: Up to approximately 32 months

Secondary Outcomes

overall survival (OS)(Up to approximately 32 months)
Progression Free Survival(PFS by investigator)(Up to approximately 32 months)
Duration of response(DoR，by BICR and investigator )(Up to approximately 32 months)
Disease control rate（DCR，by BICR and investigator）(Up to approximately 32 months)
Incidence of AEs(from Day1 to 40 days after last dose)