Menu
Recruiting NCT07183189

A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC

Phase III 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-A2009 ; Aumolertinib, Aumolertinib.
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
China
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 Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib as First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations

Overview

This study is a randomized, controlled, open-label, multicenter Phase III clinical trial designed to compare the efficacy and safety of SHR-A2009 combined with aumolertinib versus aumolertinib monotherapy in treatment-naïve subjects with EGFR-mutated, locally advanced or metastatic non-small cell lung cancer.

Interventions

  • Drug SHR-A2009 ; Aumolertinib
    SHR-A2009 administered intravenously, Aumolertinib administered orally.
  • Drug Aumolertinib
    Aumolertinib administered orally

Primary outcome measures

  • Progression-free survival (PFS) assessed by BICR according to RECIST v1.1 [Time frame: Up to approximately 38 months]
Secondary outcome measures (5)
  • overall survival (OS) [Time frame: Up to approximately 60 months]
  • Progression Free Survival(PFS by investigator) [Time frame: Up to approximately 38months]
  • Duration of response(DoR，by BICR and investigator ) [Time frame: Up to approximately 38 months]
  • Disease control rate（DCR，by BICR and investigator） [Time frame: Up to approximately 38 months]
  • Incidence of AEs [Time frame: from Day1 to 40 days after last dose]

Eligibility criteria

Inclusion criteria

  • Age 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.
  • Subjects with histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer, with EGFR mutations confirmed by tissue or blood specimens.
  • No prior systemic therapy for locally advanced, metastatic, or recurrent non-small cell lung cancer.
  • At least one measurable tumor lesion according to RECIST v1.1.
  • ECOG performance status of 0 or 1.
  • Expected survival time ≥12 weeks.
  • Adequate bone marrow and organ function.
  • Subjects must provide informed consent prior to the trial and voluntarily sign a written informed consent form.

Exclusion criteria

  • Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components.
  • Subjects with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.
  • Subjects with uncontrolled tumor-related pain, as determined by the investigator.
  • Clinically uncontrolled third-space fluid accumulation, as determined by the investigator.
  • Insufficient time interval between prior antitumor therapy and the first dose administration.
  • Major organ surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
  • History of other malignancies within ≤5 years prior to the first dose.
  • Subjects with a history of interstitial lung disease, or imaging at screening suggestive of suspected interstitial lung disease; or other moderate to severe pulmonary diseases severely affecting lung function.
  • Severe cardiovascular or cerebrovascular diseases.
  • Any severe or uncontrolled ocular lesions that, in the physician's judgment, may increase the patient's safety risk.
  • Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.
  • Severe infections within 4 weeks prior to the first dose.
  • Subjects with arterial/venous thromboembolic events within 6 months prior to the first dose of the study drug.
  • Active tuberculosis infection.
  • History of immunodeficiency, including positive HIV test.
  • Active hepatitis B or hepatitis C.
  • Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.
  • History of severe allergic reactions to aumolertinib or other monoclonal antibodies, or hypersensitivity to any component of SHR-A2009.
  • Known history of alcohol or drug dependence or drug abuse.
  • Psychiatric disorders or poor compliance.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT07183189 · SHR-A2009-302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗