Carcinoma, Non-Small-Cell LungPhase 3NCT07822542
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
A Phase 3 study testing HS-10370, Adebrelimab and Cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- HS-10370, Adebrelimab and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official 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.
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
- Being tested
- HS-10370, Adebrelimab, Cisplatin, Carboplatin, Pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10370Drug
Administered orally.
AdebrelimabDrug
Administered intravenously
CisplatinDrug
Administered intravenously
CarboplatinDrug
Administered intravenously
PemetrexedDrug
Administered intravenously
TislelizumabDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Arm A: HS-10370 plus Adebrelimab plus chemotherapy | Experimental | Not described Receives: Drug: HS-10370; Drug: Adebrelimab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed |
| Arm B: Tislelizumab plus chemotherapy | Active comparator | Not described Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Tislelizumab |
| Arm C: HS-10370 plus chemotherapy | Other | Not described Receives: Drug: HS-10370; Drug: Cisplatin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Secondary outcomes (5)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Measured: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Overall Survival (OS)
OS
Measured: Randomization to date of death from any cause. (Estimated as up to 3 years)
Overall Response Rate (ORR)
ORR per RECIST v1.1 by BICR and Investigator
Measured: Randomization to disease progression or death. (Estimated as approximately 1 year)
Duration of Response (DOR)
DOR per RECIST v1.1 by BICR and Investigator
Measured: Randomization to disease progression or death. (Estimated as approximately 1 year)
Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)
Number of Participants with a TEAE
Measured: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822542
- Sponsor's protocol ID
- HS-10370-301
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07822542
- Acronym / sponsor ID
- HS-10370-301
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10370Administered orally. | Drug | Arm A: HS-10370 plus Adebrelimab plus chemotherapy, Arm C: HS-10370 plus chemotherapy |
| AdebrelimabAdministered intravenously | Drug | Arm A: HS-10370 plus Adebrelimab plus chemotherapy |
| CisplatinAdministered intravenously | Drug | Arm A: HS-10370 plus Adebrelimab plus chemotherapy, Arm B: Tislelizumab plus chemotherapy, Arm C: HS-10370 plus chemotherapy |
| CarboplatinAdministered intravenously | Drug | Arm A: HS-10370 plus Adebrelimab plus chemotherapy, Arm B: Tislelizumab plus chemotherapy, Arm C: HS-10370 plus chemotherapy |
| PemetrexedAdministered intravenously | Drug | Arm A: HS-10370 plus Adebrelimab plus chemotherapy, Arm B: Tislelizumab plus chemotherapy |
| TislelizumabAdministered intravenously | Drug | Arm B: Tislelizumab plus chemotherapy |
Primary outcome
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)
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 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)
Overall Response Rate (ORR)
Time frame: 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-10370, Adebrelimab and Cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.