Non-Small Cell Lung CancerPhase 1NCT07899086
A Phase I Study of HS-20093 Injection in Combination Therapy in Non-Small Cell Lung Cancer
A Phase 1 study testing HS-20093, Ivonescimab and Chemotherapy in people with Non-Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company.
Trial summary
This is a multicenter, open-label, Phase 1 clinical study to evaluate the efficacy and safety of HS-20093 combination therapy in subjects with advanced or metastatic non-small cell lung cancer without actionable genomic alterations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- HS-20093, Ivonescimab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2026to 30 Jun 2030
- Phase
- Phase 1
- 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
- Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
- Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
- Previously untreated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) without actionable driver mutations
- Presence of at least one measurable target lesion.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
- Minimum life expectancy >12 weeks.
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- Adequate organ function.
- Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
- Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.
Who cannot join
- Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.
- Presence of any of the following abnormal cardiac findings:
- 1) Evidence of currently clinically significant important arrhythmia or ECG abnormality; 2) Presence of risk factors causing QT interval prolongation or arrhythmic events.
- 3. Untreated or uncontrolled brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
- 4. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 5. Severe or poorly controlled hypertension and/or diabetes mellitus. 6. Has experienced ≥ grade 2 bleeding events 7. Persistent adverse reactions caused by prior treatment. 8. History of other primary malignancies. 9. Severe infection. 10. History of severe arterial or venous thromboembolic events. 11. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
- 12. Participants with active or history of autoimmune disease with potential for recurrence.
- 13. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- 14. Pregnant or breastfeeding, or planning to breastfeed during the study.
About this study
Official title: A Phase I Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer
This is a multicenter, open-label, Phase 1 clinical study to evaluate the efficacy and safety of HS-20093 combination therapy in subjects with advanced or metastatic non-small cell lung cancer without actionable genomic alterations.
Read the detailed description
This is a multicenter, open-label, Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HS-20093 combination therapy in subjects with advanced non-small cell lung cancer (NSCLC). The study is divided into Phase 1a (safety run-in) and Phase 1b (cohort expansion).
In Phase 1a, the safety and tolerability of HS-20093 in combination with ivonescimab (± chemotherapy) will be evaluated in subjects with advanced NSCLC. After the preliminary evaluation of the safety results of Phase 1a by the Safety Review Committee (SRC), the study will proceed to Phase 1b, with randomized enrollment, to explore different treatment strategies of the combination regimens.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- HS-20093, Ivonescimab, Chemotherapy
- 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-20093Drug
Participants will receive intravenous infusions of HS-20093 and ivonescimab. HS-20093 will be administered at the pre-specified dose level(s) Q3W , until disease progression or other treatment discontinuation criteria are met.
IvonescimabDrug
Participants will receive intravenous infusions of HS-20093 and ivonescimab. Ivonescimab will be administered at at 20 mg/kg Q3W, until disease progression or other treatment discontinuation criteria are met.
ChemotherapyDrug
Participants will receive intravenous infusions of pemetrexed or nab-paclitaxel, all administered every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met. Pemetrexed at 500 mg/m², or nab-paclitaxel at 100 mg/m²per Q3W cycle.
| Study group | Role | What they receive |
|---|---|---|
| HS-20093 + ivonescimab | Experimental | Participants will receive intravenous infusions of HS-20093 and ivonescimab. HS-20093 will be administered at the pre-specified dose level(s) Q3W and ivonescimab at 20 mg/kg Q3W, until disease progression or other treatment discontinuation criteria are met. Receives: Drug: HS-20093; Drug: Ivonescimab |
| HS-20093 + ivonescimab + chemotherapy | Experimental | Participants will receive intravenous infusions of HS-20093, ivonescimab, and pemetrexed or nab-paclitaxel, all administered every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met. HS-20093 will be given at the pre-specified dose level(s), ivonescimab at 20 mg/kg, pemetrexed at 500 mg/m², or nab-paclitaxel at 100 mg/m²per Q3W cycle. Receives: Drug: HS-20093; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Dose-Limiting Toxicity (DLT)
Evaluate the number of patients with dose-limited toxicities (DLTs)
Measured: Through out the DLT period, approximately 21 days
Phase 1b: Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at phase 1b
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on RECIST version 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
Measured: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months.
Secondary outcomes (8)
Incidence and severity of adverse events (AEs)
AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, electrocardiogram, etc.
Measured: From the first dose through 90 days post end of treatment.
Duration of response (DoR) determined by investigators according to RECIST 1.1
DoR was defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
Measured: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months.
Disease control rate (DCR) determined by investigators according to RECIST 1.1.
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose].
Measured: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months.
Progression-free survival (PFS) determined by investigators according to RECIST 1.1
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from first dose or random assignment (if any) to PD or death from any cause.
Measured: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months.
Overall survival (OS)
OS was defined as the time from the first dose or random assignment (if any) to death from any cause.
Measured: From the first dose or random assignment up to death or withdrawal from study, whichever came first, assessed up to 48 months.
Observed maximum plasma concentration (Cmax) of HS-20093
Cmax will be obtained following administration of the first dose of HS-20093 during the first cycle.
Measured: Till study completion, approximately 48 months.
Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose
Tmax will be obtained following administration of the first dose of HS-20093 during the first cycle
Measured: Till study completion, approximately 48 months.
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093
Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
Measured: Till study completion, approximately 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start10 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899086
- Sponsor's protocol ID
- HS-20093-114
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07899086
- Acronym / sponsor ID
- HS-20093-114
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 27 Oct 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 multicenter, open-label, Phase 1 clinical study to evaluate the efficacy and safety of HS-20093 combination therapy in subjects with advanced or metastatic non-small cell lung cancer without actionable genomic alterations.
Detailed description
This is a multicenter, open-label, Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HS-20093 combination therapy in subjects with advanced non-small cell lung cancer (NSCLC). The study is divided into Phase 1a (safety run-in) and Phase 1b (cohort expansion).
In Phase 1a, the safety and tolerability of HS-20093 in combination with ivonescimab (± chemotherapy) will be evaluated in subjects with advanced NSCLC. After the preliminary evaluation of the safety results of Phase 1a by the Safety Review Committee (SRC), the study will proceed to Phase 1b, with randomized enrollment, to explore different treatment strategies of the combination regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20093 + ivonescimab | Experimental | Drug: HS-20093, Drug: IvonescimabParticipants will receive intravenous infusions of HS-20093 and ivonescimab. HS-20093 will be administered at the pre-specified dose level(s) Q3W and ivonescimab at 20 mg/kg Q3W, until disease progression or other treatment discontinuation criteria are met. |
| HS-20093 + ivonescimab + chemotherapy | Experimental | Drug: HS-20093, Drug: ChemotherapyParticipants will receive intravenous infusions of HS-20093, ivonescimab, and pemetrexed or nab-paclitaxel, all administered every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met. HS-20093 will be given at the pre-specified dose level(s), ivonescimab at 20 mg/kg, pemetrexed at 500 mg/m², or nab-paclitaxel at 100 mg/m²per Q3W cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
- Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
- Previously untreated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) without actionable driver mutations
- Presence of at least one measurable target lesion.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
Key exclusion criteria (8 listed)
- Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.
- Presence of any of the following abnormal cardiac findings:
- 1) Evidence of currently clinically significant important arrhythmia or ECG abnormality; 2) Presence of risk factors causing QT interval prolongation or arrhythmic events.
- 3. Untreated or uncontrolled brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
- 4. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 5. Severe or poorly controlled hypertension and/or diabetes mellitus. 6. Has experienced ≥ grade 2 bleeding events 7. Persistent adverse reactions caused by prior treatment. 8. History of other primary malignancies. 9. Severe infection. 10. History of severe arterial or venous thromboembolic events. 11. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
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-20093Participants will receive intravenous infusions of HS-20093 and ivonescimab. HS-20093 will be administered at the pre-specified dose level(s) Q3W , until disease progression or other treatment discontinuation criteria are met. | Drug | HS-20093 + ivonescimab, HS-20093 + ivonescimab + chemotherapy |
| IvonescimabParticipants will receive intravenous infusions of HS-20093 and ivonescimab. Ivonescimab will be administered at at 20 mg/kg Q3W, until disease progression or other treatment discontinuation criteria are met. | Drug | HS-20093 + ivonescimab |
| ChemotherapyParticipants will receive intravenous infusions of pemetrexed or nab-paclitaxel, all administered every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met. Pemetrexed at 500 mg/m², or nab-paclitaxel at 100 mg/m²per Q3W cycle. | Drug | HS-20093 + ivonescimab + chemotherapy |
Primary outcome
Phase 1a: Dose-Limiting Toxicity (DLT)
Time frame: Through out the DLT period, approximately 21 days
Evaluate the number of patients with dose-limited toxicities (DLTs)
Phase 1b: Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at phase 1b
Time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months.
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on RECIST version 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
8 secondary outcomes
Incidence and severity of adverse events (AEs)
Time frame: From the first dose through 90 days post end of treatment.
Duration of response (DoR) determined by investigators according to RECIST 1.1
Time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months.
Disease control rate (DCR) determined by investigators according to RECIST 1.1.
Time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months.
Progression-free survival (PFS) determined by investigators according to RECIST 1.1
Time frame: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months.
Overall survival (OS)
Time frame: From the first dose or random assignment up to death or withdrawal from study, whichever came first, assessed up to 48 months.
Observed maximum plasma concentration (Cmax) of HS-20093
Time frame: Till study completion, approximately 48 months.
Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose
Time frame: Till study completion, approximately 48 months.
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093
Time frame: Till study completion, approximately 48 months.
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 1 study testing HS-20093, Ivonescimab and Chemotherapy in people with Non-Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company.
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 9 inclusion and 8 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 27 Oct 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Phase 1a: Dose-Limiting Toxicity (DLT) (time frame: Through out the DLT period, approximately 21 days). The study lists 2 primary outcomes in all. 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 27 Oct 2026.