At a glance
ClinicalIndex Comparison Record- ✓Histologically and cytologically confirmed NSCLC
- ✓Locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene
- ✓Cohort 2: No prior systemic therapy
- ✓Cohort 1: No or at most one prior line of systemic chemotherapy for advanced/metastatic NSCLC
- ✕Small cell lung carcinoma (SCLC) components
- ✕History of other malignancies
- ✕Metastases to brainstem, meninges, spinal cord, or spinal cord compression
- ✕Active CNS metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ⅱ Clinical Study of Combination Therapy of SKB264 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating SKB264, KL-A167, and 2 other interventions for Non-small Cell Lung Cancer. Currently recruiting, targeting 110 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
SKB264 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (5mg/kg)
KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg Q3W)
Carboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle（AUC 5)
Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (75mg/m²)