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A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Wuhan, China
Phase 2
Recruiting
Research Sponsored by Klus Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until death due to any cause, up to approximately 36 months
Awards & highlights
No Placebo-Only Group
Summary
The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.
See full description
Eligible Conditions
- Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline until death due to any cause, up to approximately 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until death due to any cause, up to approximately 36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ORR
Safety and tolerability
Secondary study objectives
Duration of response (DOR)
Overall survival (OS)
Progression-free survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Cohort 9 2/3L NSCLC EGFR/ALK negativeExperimental Treatment1 Intervention
SKB264 (Dose Level 1)
Group II: Cohort 7-1 1L NSCLC with EGFR mutationExperimental Treatment2 Interventions
SKB264 (Dose Level 2) + Osimertinib
Group III: Cohort 7 1L NSCLC with EGFR mutationExperimental Treatment2 Interventions
SKB264 (Dose Level 1) + Osimertinib
Group IV: Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapyExperimental Treatment2 Interventions
SKB264 (Dose Level 1'') + Carboplatin
Group V: Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapyExperimental Treatment2 Interventions
SKB264 (Dose Level 1') + Carboplatin
Group VI: Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression levelExperimental Treatment3 Interventions
SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin
Group VII: Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression levelExperimental Treatment3 Interventions
SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin
Group VIII: Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%Experimental Treatment2 Interventions
SKB264 (Dose Level 1) + Pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6450
Pembrolizumab
2017
Completed Phase 3
~2630
Osimertinib
2017
Completed Phase 2
~1210
Find a Location
Who is running the clinical trial?
Klus Pharma Inc.Lead Sponsor
3 Previous Clinical Trials
1,589 Total Patients Enrolled
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry Sponsor
13 Previous Clinical Trials
2,538 Total Patients Enrolled