Advanced Non-small Cell Lung CancerPhase 2NCT05420220
Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection) and Axitinib in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 6 sites in China.
Trial summary
This is an open-label, multi-center, Phase 2 study in subjects with treatment-naïve locally advanced (unresectable and unable to receive radical chemoradiotherapy) or metastatic PD-L1-positive non-small cell lung cancer (NSCLC) who have received systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection) and Axitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 6 sitesChina
- Study dates
- 26 Jul 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- I01. Subjects who are able to understand the Informed Consent Form (ICF) and sign the ICF;
- I02. Male or female subjects, aged 18 years or older; willing and able to complete all required study procedures;
- I03. Subjects with histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) and stage IV (defined by the Union for International Cancer Control and the American Joint Committee on Cancer Staging System, edition 8) non-small cell lung cancer that is unresectable and unable to receive radical chemoradiotherapy;
- I04. Subjects who are PD-L1+ (TPS ≥ 1%) confirmed by central laboratory;
- I05. Subjects who must have negative EGFR mutation and ALK translocation (testing is not mandatory for subjects with squamous cell carcinoma whose EGFR/ALK gene mutation status is unknown). Subjects with known driver genes for other approved targeted drug therapies are also not eligible.
- I06. Subjects who have not received systemic therapy for locally advanced/metastatic NSCLC. Subjects who have received prior neoadjuvant, adjuvant chemotherapy, or radical chemoradiotherapy are allowed if they develop progressive disease at least 6 months after completing the aforementioned treatment;
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- I07. Subjects with at least one measurable lesion per RECIST v1.1 at baseline;
- I08. Subjects with a ECOG score of 0 or 1;
- I09. Subjects with adequate organ function assessed within 7 days prior to first trial treatment as follows:
- Hematology (without transfusion or use of hematopoietic stimulators within 14 days prior to enrollment)
- ANC≥1.5 × 109/L;
- Hemoglobin ≥ 9 g/dL;
- Platelets ≥ 100 × 109/L;
- White blood cell count (WBC) ≥ 4.0 × 109/L and ≤ 15 × 109/L;
- Renal function
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault method, see Appendix 7 for details);
- Urine protein < 2+ by urinalysis. If urine protein is ≥ 2+, the subject is eligible only if 24-hour urine protein is < 1.0 g/24 hours;
- Hepatic function
- Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for subjects with Giltert's syndrome);
- ALT/AST ≤ 2.5 × ULN (≤ 5.0 × ULN for subjects with liver metastases);
- Coagulation
- INR or PT ≤ 1.5 × ULN
- aPTT≤1.5 × ULN;
- I10. Subjects with a left ventricular ejection fraction (LVEF) of ≥ 50% (by ECHO or MUGA assessment)
- I11. Subjects who have a life expectancy of ≥ 3 months;
- I12. Female subjects of childbearing potential who have a negative serum pregnancy test within 7 days prior to the first dose;
Who cannot join
- E01. Subjects with untreated metastases to central nervous system. Subjects with a previous diagnosis of metastases to central nervous system are eligible to enroll if they have completed treatment, have been clinically stable (assessed by imaging, preferably MRI with contrast-enhanced MRI or CT) for at least 2 weeks, and their neurological and other clinical symptoms have recovered to ≤ Grade 1 per NCI-CTC AE at least 2 weeks before the first dose, and steroids for brain metastases are discontinued 7 days prior to the first dose of trial treatment.
- E02. Subjects who have received prior immune checkpoint inhibitors, including but not limited to anti-PD-1, PD-L1, CTLA-4, LAG3 agent or other immune checkpoint inhibitors; Subjects who have received prior treatment with single/multi-target inhibitors or monoclonal antibodies to VEGF or VEGFR signaling pathways;
- E03. Subjects who have undergone major surgery for any reason within 4 weeks prior to the first dose of trial treatment;
- E04. Subjects who have a history of radiotherapy that meets the following criteria and fail to recover from toxicity/complications of radiotherapy to ≤ Grade 1 per NCI-CTCAE (except alopecia and fatigue)
- Thoracic radiotherapy: subjects who have received a chest radiation dose of > 30 Gy within 24 weeks before the first dose;
- Non-thoracic radiotherapy: subjects who have received a non-thoracic radiotherapy with a dose of > 30 Gy within 4 weeks before the first dose.
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- Subjects who have received palliative radiotherapy with a dose of ≤ 30 Gy within 2 weeks before the first dose; Palliative radiotherapy for symptom control is permitted and must be completed at least 2 weeks before the start of study drug.
- E05. Subjects who have participated in a study or received the treatment with other investigational drugs within 4 weeks or less than 5 times of half-life (not less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
- E06. Subjects who have received treatment with anti-tumor vaccines, anti-tumor traditional Chinese medicine or other anti-tumor drugs with immunostimulatory effects within 2 weeks prior to the first dose;
- E07. Subjects who require systemic corticosteroids (≥ 10 mg/day prednisone or equivalent dose of other corticosteroids) or immunosuppressive therapy for 7 consecutive days within 14 days prior to the first dose; except inhaled or topical corticosteroids, or physiologic replacement doses of corticosteroids for adrenal insufficiency; short-term (≤ 7 days) corticosteroids are allowed for prophylaxis (e.g., contrast media allergy) or for the treatment of non-autoimmune disorders (e.g., delayed-type hypersensitivity reactions due to contact allergens);
- E08. Subjects who have received vaccination within 28 days prior to the first dose of trial treatment, except for inactivated vaccines.
- E09. Subjects who have interstitial lung disease, or a history of pneumonia requiring oral or intravenous corticosteroids to assist in management;
- E10. Subjects with uncontrolled hypertension (blood pressure ≥ 150/95 mmHg at rest) after standard antihypertensive therapy.
- E11. Subjects who have a history of or current autoimmune diseases, including, but not limited to, Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis), autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis (refer to the following exceptions), autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome).
- E12. Subjects who have other malignancies within 5 years before the first dose, except cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate cancer (defined as stage ≤ T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL (as measured) at diagnosis of prostate cancer, the subjects had received curative treatment and no prostate-specific antigen (PSA) biochemical recurrence), and in-situ cervical/breast cancer;
- E13. Subjects with uncontrolled comorbidities, including but not limited to:
- Active HBV or HCV infection;
- Known HIV infection or known history of acquired immune deficiency syndrome (AIDS);
- Active tuberculosis infection;
- Active infection within 4 weeks prior to the first dose of trial treatment that requires the use of systemic antibiotics ≥ 7 days;
- Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated (monthly or more frequent) drainage
- Clinically significant (that is, active) cardiovascular disease:
- Uncontrolled ≥ Grade 3 active hemorrhage by medical intervention within 4 weeks prior to the first dose of trial treatment;
- Subjects who require long-term anticoagulant therapy with warfarin (prophylactic anticoagulation for maintenance of the venous access device is permitted); Subjects who require long-term antiplatelet therapy (e.g., aspirin or clopidogrel at loading dose; or aspirin at maintenance dose of ≥ 100 mg/day; or clopidogrel at maintenance dose of ≥ 75 mg/day).
- Serious, non-healing wound, ulcer, or bone fracture;
- E14. Subjects whose tumor has invaded important blood vessels or, as judged by the investigator, the tumor is highly likely to invade important blood vessels and cause major hemorrhage during treatment.
- E15. Subjects with impaired gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of Axitinib, including but not limited to:
- Inability to take oral medication
- Prior surgical procedures affecting absorption including total/partial gastric resection;
- Malabsorption syndromes, uncontrolled nausea, vomiting, diarrhea.
- E16. Subjects with current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors or CYP3A4/5 inducers within 14 days prior to the first dose of trial treatment (e.g., grapefruit juice or grapefruit/grapefruit-related citrus fruits [e.g., oranges, pomelos], ketoconazole, miconazole etc. ). The topical use of these medications (if applicable) such as 2% ketoconazole cream is allowed;
- E17. Subjects with current use or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers within 14 days prior to enrollment or thereafter (e.g., phenobarbital, rifampin);
- E18. Subjects with toxicity related to prior therapy (including any prior investigational therapy) that has not recovered to ≤ Grade 1 per CTCAE (NCI-CTCAE v5.0) or baseline, except for alopecia of any grade;
- E19. Subjects who have received prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- E20. Subjects who have known serious hypersensitivity to antibody drugs (≥ Grade 3 per NCI-CTCAE v5.0), any history of serious drug hypersensitivity (e.g., immune-mediated hepatotoxicity, immune-mediated thrombocytopenia or anemia); or known allergy to the study drug or any of its excipients
- E21. Pregnant or lactating women;
- E22. Subjects with other medical conditions that at the discretion of investigator affect the safety or efficacy assessment or treatment compliance of the trial. These include, but are not limited to, mental illness, alcoholism, drug addiction or drug abuse.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
The first affiliated hospital, Zhejiang university
Hangzhou, Zhejiang
The Second Hospital of Anhui Medical University
Hefei, Anhui
Linyi Cancer Hospital
Linyi, Shandong
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Yantai Yuhuangding Hospital
Yantai, Shandong
About this study
Official title: An Open-Label, Multi-Center, Phase 2 Clinical Study to Evaluate Efficacy, Safety, and Tolerability of KN046 in Combination With Axitinib in Subjects With Advanced Non-Small Cell Lung Cancer
This is an open-label, multi-center, Phase 2 study in subjects with treatment-naïve locally advanced (unresectable and unable to receive radical chemoradiotherapy) or metastatic PD-L1-positive non-small cell lung cancer (NSCLC) who have received systemic therapy.
Read the detailed description
Subjects should provide tumor sample slides at screening, and the central laboratory will confirm whether the PD-L1 expression meets the inclusion criteria. Eligible subjects will receive KN046 5 mg/kg Q3W IV in combination with Axitinib 5 mg bid po, until progressive disease as judged by the investigator per RECIST v1.1, clinical progression, unacceptable toxicity, 35 doses of KN046 treatment, initiation of new systemic anti-tumor therapy, death, loss to follow-up, voluntary withdrawal, or end of the study, whichever occurs first. Subjects who discontinue one of the two trial treatments (KN046 or Axitinib) for reasons other than progressive disease may continue monotherapy with the other trial treatment. From the date of the first dose, up to 35 doses of KN046 will be administered and Axitinib will be administered until progressive disease or intolerable toxicity. Treatment with KN046 may be modified by dose interruption. Treatment with Axitinib may be modified by dose interruption or dose reduction.
The screening period will last 28 days prior to the first dose. Subjects will undergo tumor assessments at screening, every 6 weeks (± 7 days) within 54 weeks after the first dose, and every 9 weeks (± 7 days) thereafter until progressive disease as judged by the investigator per RECIST v1.1, initiation of new systemic anti-tumor therapy, death, loss to follow-up, voluntary withdrawal, or end of the study, whichever occurs first. The investigator may decide whether to confirm the progressive disease at approximately 4 to 6 weeks (not earlier than 4 weeks and not later than 6 weeks) based on the clinical symptoms of the subject after the subject first develops radiographic progressive disease (PD) per RECIST v1.1. Prior to confirmation of the progressive disease, if the subject is clinically stable, the subject is allowed to continue to receive the study drug after discussion with the medical monitor and documentation until the investigator confirms that the subject is no longer benefiting from the study drug (up to 35 doses of KN046).
Subjects will have an end of treatment (EOT) visit within 7 days at the end of trial treatment regimen KN046/Axitinib (whichever occurs later), and a safety follow-up visit 30 days (± 7 days) after the last dose of KN046/Axitinib (whichever occurs later) or decision made to discontinue all trial treatments. A safety follow-up visit will be scheduled 90 days (± 14 days) after the last dose of KN046. For subjects who discontinue treatment with KN046 first and continue treatment with Axitinib, the safety follow-up visit 90 days after the last dose of KN046 is not required if 30 days after the last dose of Axitinib is later than 90 days after the last dose of KN046.
The information of survival status and subsequent anti-tumor therapy will be collected every 12 weeks (± 14 days) after the end of treatment. Survival follow-up will continue until the end of the study. The end of the study is defined as 1 year after the last dose of all subjects, or the completion of the last study-related telephone contact or visit of the last subject, withdrawal from the study or loss to follow-up (i.e., the investigator is unable to contact the subject), or death or premature withdrawal from the study of all subjects, or the sponsor assesses that the study has met the study expectations (e.g., completion of the primary endpoint assessments), whichever occurs first.
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection), Axitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection)Biological
5 mg/kg Q3W IV
AxitinibCombination product
5mg bid po
AxitinibCombination product
3mg bid po
| Study group | Role | What they receive |
|---|---|---|
| Cohort -A | Experimental | locally advanced (non-surgical and not eligible for curative radiochemotherapy) or metastatic PD-L1 positive NSCLC subjects who have not received systemic therapy Receives: Biological: KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection); Combination Product: Axitinib |
| Cohort -B | Experimental | NSCLC subjects who have progressed after first-line or second-line PD-1/L1 or other immune checkpoint inhibitors (if first-line therapy did not include PD-1/L1 or other immune checkpoint inhibitors) Receives: Biological: KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection); Combination Product: Axitinib |
| Cohort -C | Experimental | locally advanced (non-surgical and not eligible for curative radiochemotherapy) or metastatic PD-L1 high expression (PD-L1 TPS ≥50%) NSCLC subjects who have not received systemic therapy Receives: Biological: KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection); Combination Product: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
defined as the proportion of subjects with a confirmed best overall response (BOR) of CR or PR per RECIST v1.1 as assessed by the investigator.
Measured: Up to 2 years
Secondary outcomes (7)
Duration of response (DOR)
defined as the time from the first documentation of CR or PR to the first documentation of progressive disease or death due to any cause (whichever occurs first);
Measured: Up to 2 years
Disease control rate (DCR)
defined as the proportion of subjects with a best overall response of CR, PR or SD;
Measured: Up to 2 years
Clinical benefit rate (CBR),
defined as the proportion of subjects with a best overall response of CR, PR, or SD ≥ 24 weeks;
Measured: Up to 2 years
Time to response (TTR)
defined as the time from the first trial treatment to the first documentation of objective response (CR or PR);
Measured: Up to 2 years
Progression-free survival (PFS)
defined as the time from the first trial treatment to progressive disease or death due to any cause (whichever occurs first);
Measured: Up to 2 years
Overall survival (OS)
defined as the time from the first trial treatment to death due to any cause.
Measured: Up to 2 years
Incidence and severity (as graded by CTCAE v5.0) of treatment-emergent adverse events (TEAEs),
Incidence and severity (as graded by CTCAE v5.0) of treatment-emergent adverse events (TEAEs), abnormal laboratory values, and abnormal physical examinations.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start26 Jul 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Alphamab Biopharmaceuticals Co., LtdThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Doctor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420220
- Sponsor's protocol ID
- KN046-209
- Status last verified
- May 2026
- First submitted
- 12 Jun 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Phase 2 Clinical Study to Evaluate Efficacy, Safety, and Tolerability of KN046 in Combination With Axitinib in Subjects With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05420220
- Acronym / sponsor ID
- KN046-209
- Conditions
- Advanced Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 Jun 2022 (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 an open-label, multi-center, Phase 2 study in subjects with treatment-naïve locally advanced (unresectable and unable to receive radical chemoradiotherapy) or metastatic PD-L1-positive non-small cell lung cancer (NSCLC) who have received systemic therapy.
Detailed description
Subjects should provide tumor sample slides at screening, and the central laboratory will confirm whether the PD-L1 expression meets the inclusion criteria. Eligible subjects will receive KN046 5 mg/kg Q3W IV in combination with Axitinib 5 mg bid po, until progressive disease as judged by the investigator per RECIST v1.1, clinical progression, unacceptable toxicity, 35 doses of KN046 treatment, initiation of new systemic anti-tumor therapy, death, loss to follow-up, voluntary withdrawal, or end of the study, whichever occurs first. Subjects who discontinue one of the two trial treatments (KN046 or Axitinib) for reasons other than progressive disease may continue monotherapy with the other trial treatment. From the date of the first dose, up to 35 doses of KN046 will be administered and Axitinib will be administered until progressive disease or intolerable toxicity. Treatment with KN046 may be modified by dose interruption. Treatment with Axitinib may be modified by dose interruption or dose reduction.
The screening period will last 28 days prior to the first dose. Subjects will undergo tumor assessments at screening, every 6 weeks (± 7 days) within 54 weeks after the first dose, and every 9 weeks (± 7 days) thereafter until progressive disease as judged by the investigator per RECIST v1.1, initiation of new systemic anti-tumor therapy, death, loss to follow-up, voluntary withdrawal, or end of the study, whichever occurs first. The investigator may decide whether to confirm the progressive disease at approximately 4 to 6 weeks (not earlier than 4 weeks and not later than 6 weeks) based on the clinical symptoms of the subject after the subject first develops radiographic progressive disease (PD) per RECIST v1.1. Prior to confirmation of the progressive disease, if the subject is clinically stable, the subject is allowed to continue to receive the study drug after discussion with the medical monitor and documentation until the investigator confirms that the subject is no longer benefiting from the study drug (up to 35 doses of KN046).
Subjects will have an end of treatment (EOT) visit within 7 days at the end of trial treatment regimen KN046/Axitinib (whichever occurs later), and a safety follow-up visit 30 days (± 7 days) after the last dose of KN046/Axitinib (whichever occurs later) or decision made to discontinue all trial treatments. A safety follow-up visit will be scheduled 90 days (± 14 days) after the last dose of KN046. For subjects who discontinue treatment with KN046 first and continue treatment with Axitinib, the safety follow-up visit 90 days after the last dose of KN046 is not required if 30 days after the last dose of Axitinib is later than 90 days after the last dose of KN046.
The information of survival status and subsequent anti-tumor therapy will be collected every 12 weeks (± 14 days) after the end of treatment. Survival follow-up will continue until the end of the study. The end of the study is defined as 1 year after the last dose of all subjects, or the completion of the last study-related telephone contact or visit of the last subject, withdrawal from the study or loss to follow-up (i.e., the investigator is unable to contact the subject), or death or premature withdrawal from the study of all subjects, or the sponsor assesses that the study has met the study expectations (e.g., completion of the primary endpoint assessments), whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort -A | Experimental | Biological: KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection), Combination Product: Axitiniblocally advanced (non-surgical and not eligible for curative radiochemotherapy) or metastatic PD-L1 positive NSCLC subjects who have not received systemic therapy |
| Cohort -B | Experimental | Biological: KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection), Combination Product: AxitinibNSCLC subjects who have progressed after first-line or second-line PD-1/L1 or other immune checkpoint inhibitors (if first-line therapy did not include PD-1/L1 or other immune checkpoint inhibitors) |
| Cohort -C | Experimental | Biological: KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection), Combination Product: Axitiniblocally advanced (non-surgical and not eligible for curative radiochemotherapy) or metastatic PD-L1 high expression (PD-L1 TPS ≥50%) NSCLC subjects who have not received systemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- I01. Subjects who are able to understand the Informed Consent Form (ICF) and sign the ICF;
- I02. Male or female subjects, aged 18 years or older; willing and able to complete all required study procedures;
- I03. Subjects with histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) and stage IV (defined by the Union for International Cancer Control and the American Joint Committee on Cancer Staging System, edition 8) non-small cell lung cancer that is unresectable and unable to receive radical chemoradiotherapy;
- I04. Subjects who are PD-L1+ (TPS ≥ 1%) confirmed by central laboratory;
- I05. Subjects who must have negative EGFR mutation and ALK translocation (testing is not mandatory for subjects with squamous cell carcinoma whose EGFR/ALK gene mutation status is unknown). Subjects with known driver genes for other approved targeted drug therapies are also not eligible.
Key exclusion criteria (37 listed)
- E01. Subjects with untreated metastases to central nervous system. Subjects with a previous diagnosis of metastases to central nervous system are eligible to enroll if they have completed treatment, have been clinically stable (assessed by imaging, preferably MRI with contrast-enhanced MRI or CT) for at least 2 weeks, and their neurological and other clinical symptoms have recovered to ≤ Grade 1 per NCI-CTC AE at least 2 weeks before the first dose, and steroids for brain metastases are discontinued 7 days prior to the first dose of trial treatment.
- E02. Subjects who have received prior immune checkpoint inhibitors, including but not limited to anti-PD-1, PD-L1, CTLA-4, LAG3 agent or other immune checkpoint inhibitors; Subjects who have received prior treatment with single/multi-target inhibitors or monoclonal antibodies to VEGF or VEGFR signaling pathways;
- E03. Subjects who have undergone major surgery for any reason within 4 weeks prior to the first dose of trial treatment;
- E04. Subjects who have a history of radiotherapy that meets the following criteria and fail to recover from toxicity/complications of radiotherapy to ≤ Grade 1 per NCI-CTCAE (except alopecia and fatigue)
- E05. Subjects who have participated in a study or received the treatment with other investigational drugs within 4 weeks or less than 5 times of half-life (not less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
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 |
|---|---|---|
| KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection)5 mg/kg Q3W IV | Biological | Cohort -A, Cohort -B, Cohort -C |
| Axitinib5mg bid po | Combination product | Cohort -A, Cohort -B |
| Axitinib3mg bid po | Combination product | Cohort -C |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 2 years
defined as the proportion of subjects with a confirmed best overall response (BOR) of CR or PR per RECIST v1.1 as assessed by the investigator.
7 secondary outcomes
Duration of response (DOR)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Clinical benefit rate (CBR),
Time frame: Up to 2 years
Time to response (TTR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Incidence and severity (as graded by CTCAE v5.0) of treatment-emergent adverse events (TEAEs),
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Li Zhang, Doctor principal investigator
Sun Yat-Sen University Cancer Center
6 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 KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection) and Axitinib in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 6 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 26 inclusion and 37 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: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective response rate (ORR) (time frame: Up to 2 years). 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 28 May 2026.