A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

The study is being conducted to evaluate the efficacy, and safety of HRS-7058 in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment

Eligibility criteria

Qualifiers

Age 18 years old to 75 years old ( including both ends ), regardless of gender ;

Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer ;

Histological specimens confirmed the presence of KRAS G12 C mutation ;

Participants who have failed at least one line of systemic anti-tumor treatment in the locally advanced or metastatic stage. Previous systemic anti-tumor treatment should include : platinum-containing double-agent chemotherapy and immune checkpoint inhibitor therapy ( synchronous or sequential, except that the researchers determine that it is not suitable for immune checkpoint inhibitors or chemotherapy ) ;

Disqualifiers

Subjects with active central nervous system ( CNS ) metastasis ;

Other malignant tumors occurred within 5 years before the first administration, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, ductal carcinoma in situ after radical resection, and papillary thyroid carcinoma after radical resection.

Having undergone major surgery or significant trauma within 4 weeks prior to the first use of the study drug ;

Subjects with a history of interstitial pneumonia or suspected interstitial pneumonia by imaging examination during screening ; or other lung diseases that seriously affect lung function ;

Trial design

Treatments tested in this trial

  • HRS-7058
  • Fulzerasib Tablets
  • Garsorasib Tablets
  • Glecirasib Citrate Tablets

Treatment groups

450 Participants
are divided into 4 treatment groups