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

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

Study Overview

• Status: Not yet recruiting
• Conditions: KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
• Intervention / Treatment: Drug: HRS-7058; Drug: Fulzerasib Tablets; Drug: Garsorasib Tablets; Drug: Glecirasib Citrate Tablets

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sida Zhu; Phone Number: +86-18611089618; Email: sida.zhu.sz15@hengrui.com
• Study Contact Backup: Name: Han Xu; Phone Number: +86-17721286653; Email: Han.xu@hengrui.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
      • Principal Investigator: Dingzhi Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years old to 75 years old ( including both ends ), regardless of gender ;
2. Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer ;
3. Histological specimens confirmed the presence of KRAS G12 C mutation ;
4. 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 ) ;
5. At least one measurable lesion conforming to the definition of RECIST v1.1 standard ;
6. ECOG physical score 0-1 points ;
7. Expected survival time ≥ 12 weeks ;
8. Have adequate bone marrow and organ function
9. Subjects were required to give informed consent to this study before the trial and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Subjects with active central nervous system ( CNS ) metastasis ;
2. 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.
3. Having undergone major surgery or significant trauma within 4 weeks prior to the first use of the study drug ;
4. 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 ;
5. Have serious cardiovascular and cerebrovascular diseases
6. Severe infection occurred within 4 weeks before the first administration.
7. The first study of arterial / venous thrombosis events within 3 months before medication was conducted.
8. Have a history of immunodeficiency, including HIV test positive ;
9. There is active hepatitis B or hepatitis C ;
10. Subjects with active central nervous system ( CNS ) metastasis ;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-7058	Drug: HRS-7058; HRS-7058
Active Comparator: Treatment group B: Fulzerasib Tablets	Drug: Fulzerasib Tablets; 600mg BID
Active Comparator: Treatment group C: Garsorasib Tablets	Drug: Garsorasib Tablets; 600mg BID
Active Comparator: Treatment group D: Glecirasib Citrate Tablets	Drug: Glecirasib Citrate Tablets; 800mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PFS based on BICR evaluation	about 32 months

Secondary Outcome Measures

Outcome Measure	Time Frame
OS	about 45 months
PFS based on researcher 's assessment	about 32 months
ORR based on researchers and BICR assessment	about 45 months
DoR based on researchers and BICR evaluation	about 45 months
DCR based on researcher and BICR assessment	about 45 months
The incidence and severity of adverse events ( AE )	about 45 months
the occurrence of severe adverse events ( SAE )	about 45months

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HRS-7058-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No