Non Small Cell Lung CancerPhase 2NCT07269782
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC
A Phase 2 study testing HLX43 DOSE 1, HLX43 DOSE 2 and Serplulimab in people with Non Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- HLX43 DOSE 1, HLX43 DOSE 2 and Serplulimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 30 Nov 2026
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
- 2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- 3. Histologically or cytologically confirmed NSCLC;
- 4. Diagnosed with stage II-IIIB NSCLC (according to the Union for International Cancer Control and the American Joint Committee on Cancer (AJCC) TNM staging system for lung cancer (8th edition)), without actionable genomic alterations (AGAs); subjects with non-squamous NSCLC must have previous test results confirming negative EGFR and ALK gene alterations, and if no previous EGFR and ALK test results are available, the subjects are required to undergo relevant tests at the study site; for subjects with squamous NSCLC, if the previous EGFR and/or ALK gene status is unknown, corresponding tests are not required before enrollment in this study;
- 5. Agree to undergo surgery if eligible after neoadjuvant therapy; prior to study enrollment, the subject should be assessed by the primary thoracic surgeon, who holds the main responsibility for the surgery, to confirm eligibility for R0 resection with curative intent as required by the study; the subject must have good cardiac function and be confirmed as eligible for surgical resection with curative intent;
- 6. At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to randomization;
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- 7. Subjects who agree to provide archived tumor tissue specimens that meet the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissue for PD-L1 expression testing; Note: Formalin-fixed paraffin-embedded (FFPE) tumor samples (paraffin blocks or unstained sections, which must meet the quality control criteria for testing) from the most recent surgery or biopsy at or after the diagnosis of malignant tumor and pathological reports of such specimens should be provided by subjects.
- 8. The following conditions must be met in terms of the time of the first administration of the investigational product: at least 3 weeks from the previous major surgery or medical device treatment; at least 1 week from the previous minor surgery; recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v5.0);
- 9. ECOG PS score of 0-1 within one week prior to randomization;
- 10. Life expectancy > 3 months;
- 11. Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) within 14 days prior to the first dose)；
- 12. Male and female subjects with childbearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female subjects of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.
Who cannot join
- 1. Histologically or cytologically confirmed tumor containing components of small cell lung cancer or neuroendocrine carcinoma;
- 2. Any prior systemic or local anti-tumor therapy for non-small cell lung cancer, including chemotherapy, radiotherapy, or immunotherapy;
- 3. History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;
- 4. History of adverse events leading to permanent discontinuation of immunotherapy, or history of ≥ Grade 2 immune-related pneumonitis or immune-related myocarditis;
- 5. Subjects with current or prior history of clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to the first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, interstitial pneumonitis, pneumoconiosis, drug-related pneumonitis, and pleural effusion), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within 6 months;
- 6. Patients with any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) < 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc interval ≥ 470 ms) (QTc interval is calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg after active treatment);
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- 7. Patients with active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to randomization;
- 8. Patients who have previously received other antibodies/drugs against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.;
- 9. Patients who have used moderate or potent CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization;
- 10. Patients who have received systemic corticosteroids (prednisone > 10 mg/d or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids for contrast agents, etc.;
- 11. Patients with known active or suspected autoimmune diseases. Patients with autoimmune-related hypothyroidism and receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled;
- 12. Patients who have received a live vaccine or live attenuated vaccine within 4 weeks prior to randomization;
- 13. Patients who are known to have anaphylaxis to macromolecular protein preparations/monoclonal antibodies or are allergic to any component in the formulation of the investigational product;
- 14. Patients with active tuberculosis;
- 15. Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or history of organ transplantation;
- 16. Patients with active HBV or HCV infection or HBV/HCV co-infection; Note: Patients who test positive for HBsAg or HBcAb during the screening period must undergo further HBV-DNA testing, and may be enrolled only if the test result indicates < 500 IU/mL, < 2500 copies/mL, or < ULN. Patients with detectable HBV-DNA must agree to receive treatment with anti-HBV nucleos(t)ide analogs during the study.
- Patients who test positive for HCV antibody must undergo further HCV-RNA testing, and may be enrolled only if the test result indicates < ULN.
- Patients with HBV/HCV co-infection (positive test for HBsAg or HBcAb and positive test for HCV antibody) should be excluded.
- 17. Pregnant or lactating women;
- 18. Patients who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Chang Chen, Dr, 021-65115006, chenthoracic@163.com
Chang Chen, Dr
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)
Read the detailed description
This study is a randomized, open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)，In this study, eligible subjects will be randomized at 1:1 ratio, and the patients will be administered with HLX43 at one of the two dose levels plus Serplulimab at a fixed dosage via intravenous infusion every 3 weeks (Q3W) for 3 or 4 cycle.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- HLX43 DOSE 1, HLX43 DOSE 2, Serplulimab
- 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.
HLX43 DOSE 1Drug
Also called Anti-PD-L1 ADC
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 DOSE 2Drug
Also called Anti-PD-L1 ADC
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
SerplulimabDrug
Also called HLX10
Serplulimab Injection, Recombinant humanized anti PD 1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| HLX43 DOSE 1 + Serplulimab | Experimental | Patients will receive the treatment once every 3 weeks (Q3W), for 3 or 4 cycles. Receives: Drug: HLX43 DOSE 1; Drug: Serplulimab |
| HLX43 DOSE 2 + Serplulimab | Experimental | Patients will receive the treatment once every 3 weeks (Q3W), for 3 or 4 cycles. Receives: Drug: HLX43 DOSE 2; Drug: Serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR
The percentage of residual viable tumor cells ≤ 10% in the resected primary lesion after neoadjuvant therapy, regardless of the presence of residual viable tumor cells in the lymph nodes.
Measured: At time of surgery
Secondary outcomes (3)
PCR
The absence of residual viable tumor cells in both the resected primary lesion and lymph nodes after neoadjuvant therapy.
Measured: At time of surgery
ORR
Objective response rate (ORR) is the proportion of subjects with the best overall response being CR or PR (assessed by investigator per RECIST v1.1)
Measured: up to 12 week
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0
Measured: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start20 Jan 2026
- Primary completion10 Jul 2026 (estimated)
- Study completion30 Nov 2026 (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 Shanghai Henlius BiotechThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang Chen, Dr, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269782
- Sponsor's protocol ID
- HLX43-NSCLC203
- Status last verified
- Jun 2026
- First submitted
- 26 Nov 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC
- ClinicalTrials.gov ID
- NCT07269782
- Acronym / sponsor ID
- HLX43-NSCLC203
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Dec 2025 (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.
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)
Detailed description
This study is a randomized, open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)，In this study, eligible subjects will be randomized at 1:1 ratio, and the patients will be administered with HLX43 at one of the two dose levels plus Serplulimab at a fixed dosage via intravenous infusion every 3 weeks (Q3W) for 3 or 4 cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX43 DOSE 1 + Serplulimab | Experimental | Drug: HLX43 DOSE 1, Drug: SerplulimabPatients will receive the treatment once every 3 weeks (Q3W), for 3 or 4 cycles. |
| HLX43 DOSE 2 + Serplulimab | Experimental | Drug: HLX43 DOSE 2, Drug: SerplulimabPatients will receive the treatment once every 3 weeks (Q3W), for 3 or 4 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
- 2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- 3. Histologically or cytologically confirmed NSCLC;
- 4. Diagnosed with stage II-IIIB NSCLC (according to the Union for International Cancer Control and the American Joint Committee on Cancer (AJCC) TNM staging system for lung cancer (8th edition)), without actionable genomic alterations (AGAs); subjects with non-squamous NSCLC must have previous test results confirming negative EGFR and ALK gene alterations, and if no previous EGFR and ALK test results are available, the subjects are required to undergo relevant tests at the study site; for subjects with squamous NSCLC, if the previous EGFR and/or ALK gene status is unknown, corresponding tests are not required before enrollment in this study;
- 5. Agree to undergo surgery if eligible after neoadjuvant therapy; prior to study enrollment, the subject should be assessed by the primary thoracic surgeon, who holds the main responsibility for the surgery, to confirm eligibility for R0 resection with curative intent as required by the study; the subject must have good cardiac function and be confirmed as eligible for surgical resection with curative intent;
Key exclusion criteria (20 listed)
- 1. Histologically or cytologically confirmed tumor containing components of small cell lung cancer or neuroendocrine carcinoma;
- 2. Any prior systemic or local anti-tumor therapy for non-small cell lung cancer, including chemotherapy, radiotherapy, or immunotherapy;
- 3. History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;
- 4. History of adverse events leading to permanent discontinuation of immunotherapy, or history of ≥ Grade 2 immune-related pneumonitis or immune-related myocarditis;
- 5. Subjects with current or prior history of clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to the first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, interstitial pneumonitis, pneumoconiosis, drug-related pneumonitis, and pleural effusion), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within 6 months;
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 |
|---|---|---|
| HLX43 DOSE 1Also: Anti-PD-L1 ADCHLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | HLX43 DOSE 1 + Serplulimab |
| HLX43 DOSE 2Also: Anti-PD-L1 ADCHLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. | Drug | HLX43 DOSE 2 + Serplulimab |
| SerplulimabAlso: HLX10Serplulimab Injection, Recombinant humanized anti PD 1 monoclonal antibody | Drug | HLX43 DOSE 1 + Serplulimab, HLX43 DOSE 2 + Serplulimab |
Primary outcome
MPR
Time frame: At time of surgery
The percentage of residual viable tumor cells ≤ 10% in the resected primary lesion after neoadjuvant therapy, regardless of the presence of residual viable tumor cells in the lymph nodes.
3 secondary outcomes
PCR
Time frame: At time of surgery
ORR
Time frame: up to 12 week
Incidence and severity of adverse events (AEs)
Time frame: time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 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 4 Jun 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.
Chang Chen, Dr principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX43 DOSE 1, HLX43 DOSE 2 and Serplulimab in people with Non Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 1 site in China.
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 12 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Chang Chen, Dr (021-65115006, chenthoracic@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR (time frame: At time of surgery). 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 4 Jun 2026.