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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

ConditionCarcinoma, Non-Small-Cell Lung
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

448 Participants
are divided into 3 treatment groups
Group A: Arm A: HS-10370 plus Adebrelimab plus chemotherapyExperimental treatment 5 interventions
Group B: Arm B: Tislelizumab plus chemotherapyActive comparator 4 interventions
Group C: Arm C: HS-10370 plus chemotherapyOther 3 interventions

Trial outcomes

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)

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

Secondary outcomes

1

Progression-Free Survival (PFS)

Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator

Time frame
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
2

Overall Survival (OS)

OS

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

Overall Response Rate (ORR)

ORR per RECIST v1.1 by BICR and Investigator

Time frame
Randomization to disease progression or death. (Estimated as approximately 1 year)
4

Duration of Response (DOR)

DOR per RECIST v1.1 by BICR and Investigator

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: