Carcinoma, Non-Small-Cell Lung
Conditions
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
Interventions
DRUGHS-10370
Administered orally.
DRUGAdebrelimab
Administered intravenously
DRUGCisplatin
Administered intravenously
DRUGCarboplatin
Administered intravenously
DRUGPemetrexed
Administered intravenously
DRUGTislelizumab
Administered intravenously
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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 |
| Overall Survival (OS) | Randomization to date of death from any cause. (Estimated as up to 3 years) | OS |
| Overall Response Rate (ORR) | Randomization to disease progression or death. (Estimated as approximately 1 year) | ORR per RECIST v1.1 by BICR and Investigator |
| Duration of Response (DOR) | Randomization to disease progression or death. (Estimated as approximately 1 year) | DOR per RECIST v1.1 by BICR and Investigator |
| 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) | Number of Participants with a TEAE |
Outcome results
None listed