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

September 11, 2026 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

448

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: HS-10370 plus Adebrelimab plus chemotherapy
Drug: Carboplatin
Administered intravenously
Drug: Cisplatin
Administered intravenously
Drug: Pemetrexed
Administered intravenously
Drug: HS-10370
Administered orally.
Drug: Adebrelimab
Administered intravenously
Active Comparator: Arm B: Tislelizumab plus chemotherapy
Drug: Carboplatin
Administered intravenously
Drug: Cisplatin
Administered intravenously
Drug: Pemetrexed
Administered intravenously
Drug: Tislelizumab
Administered intravenously
Other: Arm C: HS-10370 plus chemotherapy
Drug: Carboplatin
Administered intravenously
Drug: Cisplatin
Administered intravenously
Drug: HS-10370
Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Overall Survival (OS)
Time Frame: Randomization to date of death from any cause. (Estimated as up to 3 years)
OS
Randomization to date of death from any cause. (Estimated as up to 3 years)
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
Randomization to disease progression or death. (Estimated as approximately 1 year)
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
Randomization to disease progression or death. (Estimated as approximately 1 year)
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
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-10370-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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