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Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1% for Non-Small Cell Lung Cancer

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

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until death due to any cause, up to approximately 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until death due to any cause, up to approximately 36 months for reporting.

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)

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort 7-1 1L NSCLC with EGFR mutationExperimental Treatment2 Interventions
SKB264 (Dose Level 2) + Osimertinib
Group II: Cohort 7 1L NSCLC with EGFR mutationExperimental Treatment2 Interventions
SKB264 (Dose Level 1) + Osimertinib
Group III: Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapyExperimental Treatment2 Interventions
SKB264 (Dose Level 1'') + Carboplatin
Group IV: Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapyExperimental Treatment2 Interventions
SKB264 (Dose Level 1') + Carboplatin
Group V: Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression levelExperimental Treatment3 Interventions
SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin
Group VI: Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression levelExperimental Treatment3 Interventions
SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin
Group VII: 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
~6120
Pembrolizumab
2017
Completed Phase 2
~2070
Osimertinib
2017
Completed Phase 4
~1100

Find a Location

Who is running the clinical trial?

Klus Pharma Inc.Lead Sponsor
3 Previous Clinical Trials
1,533 Total Patients Enrolled
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry Sponsor
10 Previous Clinical Trials
1,952 Total Patients Enrolled
~126 spots leftby Dec 2025
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