Non Small Cell Lung CancerPhase 2NCT07253142
A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer
A Phase 2 study testing HLX43 dose 1 and HLX43 dose 2 in people with Non Small Cell Lung Cancer and Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 10 sites in China.
Trial summary
The study is to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Small Cell Lung Cancer
- What is being tested?
- HLX43 dose 1 and HLX43 dose 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesChina
- Study dates
- 5 Feb 2026to 19 Jun 2028
- 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. Voluntarily to participate in the trial, and be able to complete the study as required by the protocol;
- 2. Age ≥18 years and ≤75 years;
- 3. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC unsuitable for radical treatment without actionable gene alteration (AGA); or Histologically or cytologically confirmed SCLC unsuitable for radical treatment, with evidence of disease progression or recurrence;
- 4. Subjects must meet the following prior treatment requirements:
- Have received platinum-based chemotherapy combined with anti-PD-1/L1 monoclonal or bispecific antibodies as prior first-line treatment; have received no more than second-line treatment; or
- Have received platinum-based chemotherapy and anti-PD-1/L1 monoclonal or bispecific antibodies (in any sequence) as sequential treatment; have received no more than third-line treatment;
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- 5. Within 4 weeks prior to randomization, have at least one measurable lesion according to RECIST 1.1 efficacy evaluation criteria;
- 6. Subjects agree to provide archived tumor tissue samples (from the most recent surgery or biopsy, preferably within 2 years) that meet testing requirements or agree to undergo a biopsy to collect tumor tissue for PD-L1 expression testing;
- 7. Before the first administration of the investigational drug, there must be at least a 3-week interval or 5 half-lives of the drug (whichever is shorter) from prior major surgical procedures, device therapy, local radiotherapy (excluding palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biological therapy. There must be at least a 2-week interval from prior hormone therapy or small molecule targeted therapy, and at least a 1-week interval from traditional Chinese medicine with anti-tumor indications or minor surgical procedures. Adverse events caused by prior treatment must have recovered to CTCAE v5.0 ≤ grade 1 (excluding grade 2 peripheral neurotoxicity and alopecia);
- 8. ECOG performance status score of 0-1 within one week prior to randomization;
- 9. Expected survival time of more than 3 months;
- 10. Laboratory tests within one week prior to randomization confirm adequate organ function (within 14 days before the first administration, without receiving treatments such as transfusion, granulocyte colony-stimulating factor, thrombopoietin, or erythropoietin);
- 11. Male and female subjects with reproductive potential must agree to use at least one highly effective contraceptive method during the trial and for at least 6 months after the last administration of the investigational drug. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
Who cannot join
- 1. Mixed SCLC, mixed NSCLC, or sarcomatoid carcinoma components confirmed by tumor histology or cytology;
- 2. Imaging suggests tumor invasion of major blood vessels or important organs, or the presence of a risk of esophago-tracheal fistula or esophagopleural fistula;
- 3. Previously received any drug therapy targeting topoisomerase I, including chemotherapy or ADC drugs;
- 4. Received radical radiotherapy within 3 months prior to the first dose;
- 5. History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies treated with radical therapy (carcinoma in situ or stage I tumors), such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma;
- 6. History of adverse events leading to permanent discontinuation of immunotherapy, or a history of ≥ grade 2 immune-related pneumonitis or immune-related myocarditis;
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- 7. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- 8. Presence of spinal cord compression or clinically active central nervous system metastases (referring to untreated or symptomatic metastases, or metastases requiring corticosteroids or anticonvulsants to control related symptoms), or meningitis carcinomatosa. Subjects who have previously received treatment for brain metastases (e.g., whole-brain radiotherapy or stereotactic brain radiotherapy) may participate in the study, provided they have been clinically stable for at least 4 weeks with no imaging evidence of brain metastasis progression;
- 9. History or current presence of clinically severe lung impairment caused by pulmonary diseases, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pleural effusion, etc., within 3 months prior to the first dose) or any autoimmune, connective tissue, or inflammatory diseases potentially involving the lungs (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or subjects who have undergone pneumonectomy, which may interfere with the detection and management of suspected drug-related pulmonary toxicity; subjects with radiation pneumonitis within 6 months;
- 10. Subjects with poorly controlled cardiovascular or cerebrovascular clinical symptoms or diseases;
- 11. Presence of active systemic infectious diseases requiring intravenous antibiotic therapy within 2 weeks prior to randomization;
- 12. Use of moderate or strong CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization;
- 13. Patients who received systemic corticosteroids (prednisone >10mg/day or equivalent doses of similar drugs) or other immunosuppressive therapy within 2 weeks prior to randomization;
- 14. Presence of known active or suspected autoimmune diseases. However, patients with autoimmune-related hypothyroidism receiving thyroid hormone replacement therapy are allowed to participate in the study; patients with controlled type 1 diabetes receiving insulin therapy are allowed to participate in the study;
- 15. Received live or attenuated live vaccines within 4 weeks prior to randomization;
- 16. Known history of allergic reactions to macromolecular protein preparations/monoclonal antibodies, or allergies to components of the investigational drug formulation;
- 17. Active pulmonary tuberculosis;
- 18. History of immunodeficiency diseases, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- 19. Active HBV or HCV infection or HBV/HCV co-infection;
- 20. Pregnant or lactating women;
- 21. Subjects with a known history of psychiatric drug abuse, substance abuse, or alcoholism; patients who have ceased alcohol consumption may be enrolled;
- 22. The investigator considers the subject unsuitable for participation in this clinical study due to any clinical or laboratory abnormalities or other reasons.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Cangzhou People's Hospital
Cangzhou, Hebei
Jinsheng Shi, 0, sjsgsk@163.com
- Recruiting
Fujian Cancer Hospital
Fu'zhou, Fujian
Zhangzhou Huang, 0, 1609305255@qq.com
- Recruiting
Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Chuan Jin, 0, jinchuan595959@163.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Yanbin Zhao, 0, zhaoyb_gcp@126.com
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
Mingjun Zhang, 0, mjzhang2010@outlook.com
- Recruiting
The People's Hospital of Guangxi Zhuangzu Autonomous Region
Nanning, Guangxi, 530016
Yanrong Hao, 0, 282174944@qq.com
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Shun Lu, 0, shun_lu@hotmail.com
- Recruiting
Hubei Cancer Hospital
Wuha, Hubei
Sheng Hu, 0, ehusmn@163.com
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
Yinghua Ji, 0, 54234317@qq.com
- Recruiting
THE Affiliated Hospital of Xuzhou Medical University
Xuzhou
Bi Chen, 0, chenbi207@126.com
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 (Humanized Anti-PD-1 Monoclonal Antibody Injection) in Advanced Stage Lung Cancer
The study is to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced lung cancer.
Read the detailed description
This study is a randomized, open-label phase II clinical study to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 in combination with serplulimab in patients with advanced lung cancer who have received immunotherapy and platinum-contained chemotherapy, including actionable gene alteration (AGA) negative non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). 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).
- Conditions
- Non Small Cell Lung Cancer, Small Cell Lung Cancer
- Being tested
- HLX43 dose 1, HLX43 dose 2
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX43 dose 1Drug
Also called Serplulimab
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 Serplulimab
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.
| Study group | Role | What they receive |
|---|---|---|
| HLX43 dose 1 | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first). Receives: Drug: HLX43 dose 1 |
| HLX43 dose 2 | Experimental | Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) Receives: Drug: HLX43 dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 24 week
Secondary outcomes (5)
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by investigator per RECIST v1.1.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
ORR
ORR is the proportion of subjects with the best overall response being CR or PR (assessed by IRRC per RECIST v1.1)
Measured: Up to 24 weeks
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC per RECIST v1.1.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
OS
Overall Survival
Measured: From randomization to death from any cause (up to approximately 18 months)
Incidence and severity of adverse events (AEs)
Incidence and severity of AE 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 90 days after last dose, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start5 Feb 2026
- Primary completion18 Jun 2027 (estimated)
- Study completion19 Jun 2028 (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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253142
- Sponsor's protocol ID
- HLX43-NSCLC202
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2025
- Last updated
- 21 Jul 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 21 Jul 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 (Humanized Anti-PD-1 Monoclonal Antibody Injection) in Advanced Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT07253142
- Acronym / sponsor ID
- HLX43-NSCLC202
- Conditions
- Non Small Cell Lung Cancer, Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 18 Jun 2027 (estimated)
- Study completion
- 19 Jun 2028 (estimated)
- First posted
- 28 Nov 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 to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced lung cancer.
Detailed description
This study is a randomized, open-label phase II clinical study to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 in combination with serplulimab in patients with advanced lung cancer who have received immunotherapy and platinum-contained chemotherapy, including actionable gene alteration (AGA) negative non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). 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).
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 | Experimental | Drug: HLX43 dose 1Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first). |
| HLX43 dose 2 | Experimental | Drug: HLX43 dose 2Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Voluntarily to participate in the trial, and be able to complete the study as required by the protocol;
- 2. Age ≥18 years and ≤75 years;
- 3. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC unsuitable for radical treatment without actionable gene alteration (AGA); or Histologically or cytologically confirmed SCLC unsuitable for radical treatment, with evidence of disease progression or recurrence;
- 4. Subjects must meet the following prior treatment requirements:
- 5. Within 4 weeks prior to randomization, have at least one measurable lesion according to RECIST 1.1 efficacy evaluation criteria;
Key exclusion criteria (22 listed)
- 1. Mixed SCLC, mixed NSCLC, or sarcomatoid carcinoma components confirmed by tumor histology or cytology;
- 2. Imaging suggests tumor invasion of major blood vessels or important organs, or the presence of a risk of esophago-tracheal fistula or esophagopleural fistula;
- 3. Previously received any drug therapy targeting topoisomerase I, including chemotherapy or ADC drugs;
- 4. Received radical radiotherapy within 3 months prior to the first dose;
- 5. History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies treated with radical therapy (carcinoma in situ or stage I tumors), such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma;
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: SerplulimabHLX43 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 |
| HLX43 dose 2Also: SerplulimabHLX43 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 |
Primary outcome
ORR
Time frame: up to 24 week
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)
5 secondary outcomes
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
ORR
Time frame: Up to 24 weeks
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
OS
Time frame: From randomization to death from any cause (up to approximately 18 months)
Incidence and severity of adverse events (AEs)
Time frame: time from the date of the first dose of study drug until 90 days after last dose, assessed up to 18 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 21 Jul 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.
10 sites 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 and HLX43 dose 2 in people with Non Small Cell Lung Cancer and Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 10 sites 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 13 inclusion and 22 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 Yongqing Lin (18925185148, yongqing_lin@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 24 week). 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 21 Jul 2026.