Non-Small Cell Lung Cancer
Conditions
Brief 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).
Detailed description
This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus pembrolizumab as firstline treatment for PD-L1 positive patients with locally advanced or metastatic non-small cell lung cancer.
Interventions
DRUGSKB264
IV Infusion
DRUGPembrolizumab
IV Infusion
Sponsors
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. 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. 2. No prior systemic anti-cancer therapy for locally advanced or metastatic disease. 3. Participants whose tumours are PD-L1 TPS ≥ 1%. 4. At least one measurable lesion per RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization. 6. A life expectancy of at least 12 weeks. 7. Adequate organ and bone marrow function.
Exclusion criteria
Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) | Randomization up to approximately 22months | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Randomization up to approximately 40 months | OS is defined as the time from randomization until the date of death due to any cause. |
| Progression-Free Survival (PFS) assessed by Investigator | Randomization up to approximately 22months | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first. |
| Objective Response Rate (ORR) | Randomization up to approximately 22months | ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1 |
| Disease control rate (DCR) | Randomization up to approximately 22months | DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/ investigator per RECIST 1.1 |
| Duration of Response (DoR) | Randomization up to approximately 22months | DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first. |
| Time to Response (TTR) | Randomization up to approximately 22months | TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1. |
| Health-Related Quality of Life Assessment | Randomization up to approximately 22months | Compare the health-related quality of life (HRQoL) of SKB264 in combination with pembrolizumab and pembrolizumab monotherapy by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) and Quality of Life Questionnaire - Lung Cancer Module 13 (EORTC QLQ-LC13) |
| AEs and SAEs | All AEs should be observed and recorded from the first dose until 30 days after the last dose. SAEs were observed and recorded until 90 days after the last dose of pembrolizumab or 30 days after the last dose of SKB264,whichever occurred later. | Incidence and severity of AEs and SAEs (per CTCAE v5.0), and clinically significant abnormal laboratory results |
| PK | Randomization up to approximately 22months | PK parameters of SKB264-ADC, SKB264-TAB and free KL610023, such as maximum concentration (Cmax), minimum concentration (Cmin ), etc. |
| Immunogenicity | Randomization up to approximately 22months | Immunogenicity test results of SKB264 |
| Biomarkers | Tumor tissue samples should be provided for TROP2 testing after subjects are eligible for screening. | Correlation between the expression level of TROP2 in tumor tissues and the efficacy. |
Countries
China
Outcome results
None listed