HS-10370
DrugAdministered orally.
NCT Number: NCT07822542
This is a trial to evaluate the efficacy, safety, and tolerability of HS-10370 in combination with Platinum-based Doublet Chemotherapy With or Without Adebrelimab Versus Tislelizumab Plus Platinum-based Doublet Chemotherapy as first-line treatment in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered orally.
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Time frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Time frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Time frame: Randomization to date of death from any cause. (Estimated as up to 3 years)
OS
Time frame: Randomization to disease progression or death. (Estimated as approximately 1 year)
ORR per RECIST v1.1 by BICR and Investigator
Time frame: Randomization to disease progression or death. (Estimated as approximately 1 year)
DOR per RECIST v1.1 by BICR and Investigator
Time frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Number of Participants with a TEAE
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Industry
A Randomized, Open-label, Controlled, Multicenter Phase 3 Trial of HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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