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

NCT07822542 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HS-10370-301
• Study Type: interventional
• Target: 448
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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 Outcomes (5)

• Progression-Free Survival (PFS)

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

• Overall Survival (OS)

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

• Overall Response Rate (ORR)

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

• Duration of Response (DOR)

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

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

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

Study Arms (3)

Arm A: HS-10370 plus Adebrelimab plus chemotherapy

EXPERIMENTAL

Drug: HS-10370; Drug: Adebrelimab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

Arm B: Tislelizumab plus chemotherapy

ACTIVE COMPARATOR

Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Tislelizumab

Arm C: HS-10370 plus chemotherapy

OTHER

Drug: HS-10370; Drug: Cisplatin; Drug: Carboplatin

Interventions

HS-10370 DRUG

Administered orally.

Arm A: HS-10370 plus Adebrelimab plus chemotherapy; Arm C: HS-10370 plus chemotherapy

Adebrelimab DRUG

Administered intravenously

Arm A: HS-10370 plus Adebrelimab plus chemotherapy

Cisplatin DRUG

Administered intravenously

Arm A: HS-10370 plus Adebrelimab plus chemotherapy; Arm B: Tislelizumab plus chemotherapy; Arm C: HS-10370 plus chemotherapy

Carboplatin DRUG

Administered intravenously

Arm A: HS-10370 plus Adebrelimab plus chemotherapy; Arm B: Tislelizumab plus chemotherapy; Arm C: HS-10370 plus chemotherapy

Pemetrexed DRUG

Administered intravenously

Arm A: HS-10370 plus Adebrelimab plus chemotherapy; Arm B: Tislelizumab plus chemotherapy

Tislelizumab DRUG

Administered intravenously

Arm B: Tislelizumab plus chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Carboplatin; Pemetrexed; tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

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: September 11, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 16, 2026

Record last verified: 2026-09