Actively Recruiting
SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-12
110
Participants Needed
2
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.
CONDITIONS
Official Title
SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 75 years at consent
- Confirmed diagnosis of non-small cell lung cancer by histology or cytology
- Cohort 1: Locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, with no or at most one prior systemic chemotherapy for advanced/metastatic NSCLC
- Cohort 2: Locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, with no prior systemic therapy
- Cohort 3: Locally advanced/metastatic NSCLC with EGFR activating mutation and negative ALK fusion gene, with prior failure of EGFR-TKI treatment
- Ability to provide fresh or archival tumor tissue for biomarker testing
- At least one measurable lesion according to RECIST v1.1; patients with only skin or bone lesions are excluded
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with expected survival of at least 12 weeks
- Adequate organ and bone marrow function
- Effective contraception use during treatment and for 6 months after last dose for women of childbearing age and men with partners of childbearing age
- Voluntary agreement to participate, signed informed consent, and compliance with study visits and procedures
You will not qualify if you...
- Presence of small cell lung carcinoma components
- History of other malignancies
- Metastases to brainstem, meninges, spinal cord, or spinal cord compression
- Active central nervous system metastases
- Tumor surrounding important blood vessels or risk of fatal major hemorrhage
- Serious or uncontrolled cardiac disease requiring treatment
- Noninfectious interstitial lung disease or history of pneumonia requiring steroid therapy
- Serious lung function impairment from lung disease
- Uncontrolled systemic diseases such as hypertension or diabetes
- Clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Active hepatitis B or C infection, HIV/AIDS, or positive syphilis antibody test
- Active tuberculosis
- Known hypersensitivity to study drugs or severe allergic reactions to monoclonal antibodies
- History of allogeneic organ or hematopoietic stem cell transplantation
- Pregnant or lactating women
- Rapid clinical deterioration before first dose
- Any condition deemed unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
X
XiaoPin Jin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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