Non-small Cell Lung Cancer
Conditions
Brief 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.
Detailed description
This is a multicenter, open-label study of SKB264 as combination therapy or monotherapy in subjects with NSCLC. Approximately 498 subjects will be enrolled in this study including around 88 subjects for the safety run-in period and 410 subjects for the expansion period.
Interventions
DRUGSKB264
intravenous (IV) infusion (Q2W or Q3W)
DRUGPembrolizumab
intravenous (IV) infusion (400mg, Q6W)
DRUGCarboplatin
intravenous (IV) infusion (AUC5, Q3W)
DRUGOsimertinib
80mg, QD
Sponsors
Klus Pharma Inc.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender; 2. Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ; 3. Subjects for NSCLC should be confirmed to be EGFR (Epidermal growth factor receptor) wild-type and ALK (Anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor EGFR mutation; 4. Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, no prior systemic treatment; subjects with EGFR mutation, no prior systemic treatment or failed prior EGFR-TKI (Tyrosine kinase inhibitor) treatment; 5. Subjects are able to provide tumor blocks or slides before the first dose of study intervention; 6. Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; 7. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1; 8. Life expectancy at least 3 months for the subject; 9. Adequate organ function; 10. Subjects must have recovered from all toxicities led by prior treatment; 11. Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects; 12. Subjects should voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.
Exclusion criteria
1. Subjects with mixed SCLC histopathological features; 2. Subjects with a known history of prior malignancy; 3. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases; 4. Subjects with ≥ Grade 2 peripheral neuropathy; 5. Subjects who had arteriovenous thromboembolic events, tumor invasion/encasement of vital organs/vessels, risk of esophageal-tracheal/pleural fistula, or current superior vena cava syndrome; 6. Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease; 7. Subjects who suffer from cardiovascular diseases of clinical significance; 8. Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids; 9. Subjects with uncontrolled systemic disease as judged by the Investigator; 10. Subjects with active autoimmune disease that required systemic treatment in the past 2 years; 11. Subjects with active hepatitis B or hepatitis C; 12. Subjects with known history of Human Immunodeficiency Virus (HIV) 13. Subjects with known active tuberculosis; 14. Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study; 16. Subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention; 17. Subjects with other circumstances that, in the opinion of the Investigator, are not appropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months | Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs |
| ORR | The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months | Objective response rate (ORR) per RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months | For subjects with a confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until radiographic disease progression or death due to any cause, whichever occurs first |
| Progression-free survival (PFS) | From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months | The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first |
| Overall survival (OS) | From baseline until death due to any cause, up to approximately 36 months | the time period from the start of study intervention to death due to any cause. |
Countries
China, Georgia, Romania, South Korea, Spain, Turkey (Türkiye)
Outcome results
None listed