Actively Recruiting
Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer
Led by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Updated on 2024-05-01
54
Participants Needed
6
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign the Informed Consent Form
- Male or female aged 18 years or older, willing and able to complete all study procedures
- Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-small cell lung cancer that is unresectable and not suitable for radical chemoradiotherapy
- PD-L1 positive (TPS 2 1%) confirmed by central laboratory
- Negative for EGFR mutation and ALK translocation (not mandatory for squamous cell carcinoma with unknown gene status); no known driver genes for approved targeted therapies
- No prior systemic therapy for locally advanced/metastatic NSCLC; prior neoadjuvant, adjuvant chemotherapy, or radical chemoradiotherapy allowed if progression occurred at least 6 months after treatment completion
- At least one measurable lesion per RECIST v1.1 at baseline
- ECOG performance status score of 0 or 1
- Adequate organ function within 7 days before first trial treatment including hematology, renal, hepatic, and coagulation parameters as specified
- Left ventricular ejection fraction 2 50% by ECHO or MUGA
- Life expectancy of 3 months or more
- Female subjects of childbearing potential with a negative serum pregnancy test within 7 days prior to first dose
You will not qualify if you...
- Untreated metastases to the central nervous system; previously treated brain metastases must be stable with symptoms 2 Grade 1 and off steroids for 7 days before first dose
- Prior treatment with immune checkpoint inhibitors or VEGF/VEGFR pathway inhibitors
- Major surgery within 4 weeks before first dose
- Recent radiotherapy with unresolved toxicity above Grade 1, with specific timing and dose restrictions
- Participation in other investigational drug studies within 4 weeks or less than 5 half-lives prior to first dose
- Use of anti-tumor vaccines or immunostimulatory drugs within 2 weeks before first dose
- Use of systemic corticosteroids (>=10 mg/day prednisone) or immunosuppressants within 14 days prior to first dose, with exceptions
- Vaccination within 28 days prior to first dose except inactivated vaccines
- Interstitial lung disease or history of pneumonia requiring corticosteroids
- Uncontrolled hypertension (>=150/95 mmHg) despite treatment
- History or current autoimmune diseases as specified
- Other malignancies within 5 years except certain cured or low-risk cancers
- Uncontrolled comorbidities including active infections, significant cardiovascular disease, bleeding disorders, or serious wounds
- Tumors invading important blood vessels with high risk of major hemorrhage
- Impaired gastrointestinal function affecting Axitinib absorption
- Current or planned use of strong CYP3A4/5 inhibitors or inducers within 14 days prior to first dose
- Unresolved toxicity from prior therapies greater than Grade 1 except alopecia
- Prior allogeneic stem cell or solid organ transplantation
- Known serious hypersensitivity to antibody drugs or study drug components
- Pregnant or lactating women
- Other medical conditions affecting safety or study compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
3
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
4
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Actively Recruiting
5
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
6
The first affiliated hospital, Zhejiang university
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
L
Li Zhang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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