Actively Recruiting
A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-02-05
432
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.
CONDITIONS
Official Title
A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed non-squamous NSCLC that is locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) and not suitable for surgery or radical radiochemotherapy
- Negative for EGFR-sensitive mutations and ALK fusion gene, and no known ROS1, NTRK, or BRAF V600E mutations approved for targeted therapy
- No prior systemic anti-cancer treatment for locally advanced or metastatic NSCLC
- Tumor PD-L1 tumor proportion score less than 1%
- At least one measurable tumor lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 without worsening within 7 days before randomization
- Estimated life expectancy of at least 12 weeks
- Adequate organ and bone marrow function
You will not qualify if you...
- Tumors containing more than 10% of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell carcinoma
- Previous treatment with immune checkpoint inhibitors, checkpoint agonists, or immune cell therapies targeting tumor immune mechanisms
- Active second cancer other than NSCLC
- Symptomatic or uncontrolled cardiovascular disease or serious blood clots
- History or current noninfectious pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic treatment within 2 weeks before randomization
- Active hepatitis B or C infection
- HIV positive, AIDS history, or active syphilis infection
- Major surgery within 4 weeks before randomization or planned during the study
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Oriental Hospital
Shanghai, China
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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