Actively Recruiting
A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
420
Participants Needed
2
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.
CONDITIONS
Official Title
A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years at the time of informed consent
- Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC not suitable for radical surgery or radiotherapy
- No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC
- Confirmed EGFR-sensitive mutations
- Tumor tissue samples obtained at or after diagnosis of locally advanced or metastatic tumor
- At least one target lesion measurable by RECIST v1.1
- ECOG performance status of 0 or 1 within 7 days before randomization
- Life expectancy of at least 12 weeks
- Adequate organ and bone marrow function
You will not qualify if you...
- Presence of small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or more than 10% squamous cell carcinoma components
- Prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC
- Prior targeted TROP2 therapy or drugs targeting topoisomerase I, including antibody-drug conjugates
- Known meningeal, brainstem, spinal cord metastases or compression, or active CNS metastases
- Other malignancies within 3 years before randomization
- Significant abnormalities on resting electrocardiogram
- Cardiovascular or cerebrovascular diseases or risk factors
- History or presence of interstitial lung disease, drug-induced ILD, non-infectious pneumonitis requiring steroids
- Severe lung injuries from lung diseases
- Unresolved toxicities from previous anti-tumor therapy above Grade 1
- Use of systemic corticosteroids above 10 mg/day prednisone equivalent or immunosuppressive agents within 2 weeks prior to randomization
- Known active pulmonary tuberculosis
- History of allogeneic organ or hematopoietic stem cell transplant
- Active hepatitis B or C infection
- Positive HIV test, AIDS history, or active syphilis infection
- Allergy to osimertinib, SKB264, or their components including polysorbate-20
- Vaccination with live vaccines within 30 days prior or planned during the study
- Pregnant or breastfeeding women
- Presence of local or systemic diseases caused by non-malignancies or secondary to tumors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xiaoping Jin PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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