KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard TreatmentPhase 3NCT07601048
A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
A Phase 3 study testing HRS-7058, Fulzerasib Tablets and Garsorasib Tablets in people with KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
- What is being tested?
- HRS-7058, Fulzerasib Tablets and Garsorasib Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ;
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- 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 join
- 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.
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- 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 ;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Dingzhi Huang
About this study
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
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
- Being tested
- HRS-7058, Fulzerasib Tablets, Garsorasib Tablets, Glecirasib Citrate Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7058Drug
HRS-7058
Fulzerasib TabletsDrug
600mg BID
Garsorasib TabletsDrug
600mg BID
Glecirasib Citrate TabletsDrug
800mg QD
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-7058 | Experimental | Not described Receives: Drug: HRS-7058 |
| Treatment group B: Fulzerasib Tablets | Active comparator | Not described Receives: Drug: Fulzerasib Tablets |
| Treatment group C: Garsorasib Tablets | Active comparator | Not described Receives: Drug: Garsorasib Tablets |
| Treatment group D: Glecirasib Citrate Tablets | Active comparator | Not described Receives: Drug: Glecirasib Citrate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS based on BICR evaluation
Measured: about 32 months
Secondary outcomes (7)
OS
Measured: about 45 months
PFS based on researcher 's assessment
Measured: about 32 months
ORR based on researchers and BICR assessment
Measured: about 45 months
DoR based on researchers and BICR evaluation
Measured: about 45 months
DCR based on researcher and BICR assessment
Measured: about 45 months
The incidence and severity of adverse events ( AE )
Measured: about 45 months
the occurrence of severe adverse events ( SAE )
Measured: about 45months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJun 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard TreatmentStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601048
- Sponsor's protocol ID
- HRS-7058-301
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07601048
- Acronym / sponsor ID
- HRS-7058-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS-7058 | Experimental | Drug: HRS-7058 |
| Treatment group B: Fulzerasib Tablets | Active comparator | Drug: Fulzerasib Tablets |
| Treatment group C: Garsorasib Tablets | Active comparator | Drug: Garsorasib Tablets |
| Treatment group D: Glecirasib Citrate Tablets | Active comparator | Drug: Glecirasib Citrate Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 ;
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-7058HRS-7058 | Drug | Treatment group A: HRS-7058 |
| Fulzerasib Tablets600mg BID | Drug | Treatment group B: Fulzerasib Tablets |
| Garsorasib Tablets600mg BID | Drug | Treatment group C: Garsorasib Tablets |
| Glecirasib Citrate Tablets800mg QD | Drug | Treatment group D: Glecirasib Citrate Tablets |
Primary outcome
PFS based on BICR evaluation
Time frame: about 32 months
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS-7058, Fulzerasib Tablets and Garsorasib Tablets in people with KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sida Zhu (+86-18611089618, sida.zhu.sz15@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS based on BICR evaluation (time frame: about 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.