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HRS-7058 Compared With Other KRAS G12C Inhibitors in Advanced Non-Small Cell Lung Cancer

Compares HRS-7058 with other KRAS G12C inhibitors in advanced non-small cell lung cancer.

Key facts

Who runs it
Shandong Suncadia Medicine Co., Ltd.
Where
Tianjin, ChinaSee the site
Trial code
Registry title
A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
Status
Not yet recruiting
Phase
Phase 3
People taking part
450 people, planned
Started
Jun 2026
Expected to end
May 2029
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • HRS-7058
  • Fulzerasib Tablets
  • Garsorasib Tablets
  • Glecirasib Citrate Tablets
Record updated
22 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with lung cancer (non-small cell) that has spread or is advanced, has a KRAS G12C change, and did not respond to earlier standard treatment.

Age
18 to 75 years, both ends included.
Sex
All sexes can join.
Disease stage
Non-small cell lung cancer that is locally advanced or has spread, confirmed by a tissue or cell test. At least one lesion that can be measured. ECOG score 0-1.
Earlier treatment
Must have failed at least one line of whole-body anti-tumor treatment. This should include platinum-containing double-agent chemotherapy and immune checkpoint inhibitor therapy, unless the researchers judge one of these cannot be used.
Biomarker or test result
A KRAS G12C mutation confirmed in a tissue sample.

Main reasons for not taking part

  • Active cancer spread to the brain or spinal cord (CNS)
  • Another cancer within the past 5 years, with a few treated exceptions
  • Major surgery or serious injury within 4 weeks before the first dose
  • History of interstitial pneumonia or other lung disease that seriously affects lung function
  • History of immune deficiency, including a positive HIV test, or active hepatitis B or C

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Having undergone major surgery or significant trauma within 4 weeks prior to the first use of the study drug
  • 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
  • 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
  • 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
  • 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
  • Subjects with active central nervous system ( CNS ) metastasis

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Tianjin Medical University Cancer Institute and HospitalTianjin, ChinaContact: Dingzhi Huang (principal investigator)No longer taking part

About the trial

What the trial wants to find out

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

The 4 groups in the trial

  • Treatment group A: HRS-7058Treatment being tested

    Treatment: HRS-7058

  • Treatment group B: Fulzerasib TabletsExisting treatment, for comparison

    Treatment: Fulzerasib Tablets

  • Treatment group C: Garsorasib TabletsExisting treatment, for comparison

    Treatment: Garsorasib Tablets

  • Treatment group D: Glecirasib Citrate TabletsExisting treatment, for comparison

    Treatment: Glecirasib Citrate Tablets

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
HRS-7058 Compared With Other KRAS G12C Inhibitors in Advanced Non-Small Cell Lung CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07601048, who can take part
Record updated
22 May 2026