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Not yet recruiting NCT07601048

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

Phase III Interventional KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment

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: HRS-7058, Fulzerasib Tablets, Garsorasib Tablets, Glecirasib Citrate Tablets.
Who it may be relevant to
Registry conditions: KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment. 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 Trial of HRS-7058 Versus the Investigator-Selected KRAS G12C Inhibitor in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment

Overview

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

Interventions

  • Drug HRS-7058
    HRS-7058
  • Drug Fulzerasib Tablets
    600mg BID
  • Drug Garsorasib Tablets
    600mg BID
  • Drug Glecirasib Citrate Tablets
    800mg QD

Primary outcome measures

  • PFS based on BICR evaluation [Time frame: about 32 months]
Secondary outcome measures (7)
  • OS [Time frame: about 45 months]
  • PFS based on researcher 's assessment [Time frame: about 32 months]
  • ORR based on researchers and BICR assessment [Time frame: about 45 months]
  • DoR based on researchers and BICR evaluation [Time frame: about 45 months]
  • DCR based on researcher and BICR assessment [Time frame: about 45 months]
  • The incidence and severity of adverse events ( AE ) [Time frame: about 45 months]
  • the occurrence of severe adverse events ( SAE ) [Time frame: about 45months]

Eligibility criteria

Inclusion criteria

  • 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 ) ;
  • At least one measurable lesion conforming to the definition of RECIST v1.1 standard ;
  • ECOG physical score 0-1 points ;
  • Expected survival time ≥ 12 weeks ;
  • Have adequate bone marrow and organ function
  • Subjects were required to give informed consent to this study before the trial and voluntarily sign a written informed consent form.

Exclusion criteria

  • 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 ;
  • Have serious cardiovascular and cerebrovascular diseases
  • Severe infection occurred within 4 weeks before the first administration.
  • The first study of arterial / venous thrombosis events within 3 months before medication was conducted.
  • Have a history of immunodeficiency, including HIV test positive ;
  • There is active hepatitis B or hepatitis C ;
  • Subjects with active central nervous system ( CNS ) metastasis ;

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
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07601048 · HRS-7058-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗