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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 ) ;

Disqualifiers

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 ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-7058

    Drug

    HRS-7058

  • Fulzerasib Tablets

    Drug

    600mg BID

  • Garsorasib Tablets

    Drug

    600mg BID

  • Glecirasib Citrate Tablets

    Drug

    800mg QD

Treatment groups

450 Participants
are divided into 4 treatment groups
Group A: Treatment group A: HRS-7058Experimental treatment 1 intervention
Group B: Treatment group B: Fulzerasib TabletsActive comparator 1 intervention
Group C: Treatment group C: Garsorasib TabletsActive comparator 1 intervention
Group D: Treatment group D: Glecirasib Citrate TabletsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS based on BICR evaluation

Time frame
about 32 months

Secondary outcomes

1

OS

Time frame
about 45 months
2

PFS based on researcher 's assessment

Time frame
about 32 months
3

ORR based on researchers and BICR assessment

Time frame
about 45 months
4

DoR based on researchers and BICR evaluation

Time frame
about 45 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: