A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally… (NCT06448312) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
China406 participantsStarted 2024-06-07
Plain-language summary
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage IV) NSCLC that is not amenable to radical surgery and/or radical radiotherapy regardless of concurrent chemotherapy.
✓. No prior systemic anti-cancer therapy for locally advanced or metastatic disease.
✓. Participants whose tumours are PD-L1 TPS ≥ 1%.
✓. At least one measurable lesion per RECIST v1.1.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization.
✓. A life expectancy of at least 12 weeks.
✓. Adequate organ and bone marrow function.
Exclusion criteria
✕. Active second malignancy.
✕. Uncontrolled or clinical significant cardiovascular disease.
✕. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
✕. Active infection requiring systemic therapy within 2 weeks of randomization.
✕. Active hepatitis B or hepatitis C virus infection.
✕. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
What they're measuring
1
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Timeframe: Randomization up to approximately 22months