A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed… (NCT07601048) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
China450 participantsStarted 2026-06
Plain-language summary
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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion criteria
. Subjects with active central nervous system ( CNS ) metastasis ;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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 ;