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NCT Number: NCT07822542

A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants are able to comply with the process of the protocol.
  • Men or women greater than or equal to 18 years
  • At least one measurable lesion in accordance with RECIST 1.1
  • Must have an ECOG performance status of 0 or 1.
  • Must have adequate laboratory parameters.
  • Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.
  • Documentation of the presence of a KRAS G12C mutation
  • Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit.

Exclusion criteria

  • Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.
  • Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.
  • Active brain metastases.
  • Participants with uncontrolled pleural, ascites or pericardial effusion
  • History of other primary malignancies.
  • Abnormal cardiac examination results.
  • Severe, uncontrolled or active cardiovascular disorders.
  • Uncontrolled hypertension.
  • Severe bleeding symptoms or bleeding tendencies.
  • Severe arteriovenous thrombosis occurred
  • Serious infection.
  • Continuous use of glucocorticoids
  • Active infectious diseases.
  • Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
  • Interstitial lung disease (ILD).
  • Serious neurological or mental disorders.
  • Active autoimmune diseases.

Treatment and study plan

HS-10370

Drug

Administered orally.

Adebrelimab

Drug

Administered intravenously

Cisplatin

Drug

Administered intravenously

carboplatin

Drug

Administered intravenously

Pemetrexed

Drug

Administered intravenously

Tislelizumab

Drug

Administered intravenously

Primary outcomes

  1. Progression-Free Survival (PFS)

    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)

Secondary outcomes

  1. Progression-Free Survival (PFS)

    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

  2. Overall Survival (OS)

    Time frame: Randomization to date of death from any cause. (Estimated as up to 3 years)

    OS

  3. Overall Response Rate (ORR)

    Time frame: Randomization to disease progression or death. (Estimated as approximately 1 year)

    ORR per RECIST v1.1 by BICR and Investigator

  4. Duration of Response (DOR)

    Time frame: Randomization to disease progression or death. (Estimated as approximately 1 year)

    DOR per RECIST v1.1 by BICR and Investigator

  5. Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)

    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

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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