NCT07601048

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
36mo left

Started Jun 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

May 15, 2026

Last Update Submit

May 15, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • PFS based on BICR evaluation

    about 32 months

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (4)

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

Interventions

HRS-7058DRUG

HRS-7058

Treatment group A: HRS-7058
Fulzerasib TabletsDRUG

600mg BID

Treatment group B: Fulzerasib Tablets
Garsorasib TabletsDRUG

600mg BID

Treatment group C: Garsorasib Tablets
Glecirasib Citrate TabletsDRUG

800mg QD

Treatment group D: Glecirasib Citrate Tablets

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 ;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Central Study Contacts

Sida Zhu

CONTACT

+86-18611089618sida.zhu.sz15@hengrui.com

Han Xu

CONTACT

+86-17721286653Han.xu@hengrui.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 22, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

CN(1)