A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender; Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ; 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; 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; Subjects are able to provide tumor blocks or slides before the first dose of study intervention; Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1; Life expectancy at least 3 months for the subject; Adequate organ function; Subjects must have recovered from all toxicities led by prior treatment; Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects; 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 Subjects with mixed SCLC histopathological features; Subjects with a known history of prior malignancy; Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases; Subjects with ≥ Grade 2 peripheral neuropathy; Subjects who had arteriovenous thromboembolic events; Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease; Subjects who suffer from cardiovascular diseases of clinical significance; Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids; Subjects with uncontrolled systemic disease as judged by the Investigator; Subjects with active autoimmune disease that required systemic treatment in the past 2 years; Subjects with active hepatitis B or hepatitis C; Subjects with known history of Human Immunodeficiency Virus (HIV) Subjects with known active tuberculosis; Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study; Subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention; Subjects with other circumstances that, in the opinion of the Investigator, are not appropriate for participation in this study.
Sites / Locations
- Beijing Cancer Hospital
- Fujian Cancer Hospital
- Sun Yat-sen University, Cancer CenterRecruiting
- Harbin Medical University Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- Hunan Cancer Hospital
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- Jilin Cancer Hospital
- The First Hospital of Chinese Medical University
- Shanghai Chest Hospital
- Shanghai East Hospital
- West China Hospital Si Chuan University
- Sichuan Cancer Hospital
- The First Affiliated Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1 EGFR wild-type and ALK fusion genes negative (PD-L1 TPS ≥ 1 %)
Cohort 2 EGFR wild-type and ALK fusion genes negative (PD-L1 TPS ≥ 1 %)
Cohort 3 EGFR wild-type and ALK fusion genes negative
Cohort 4 EGFR wild-type and ALK fusion genes negative
Cohort 5 EGFR sensitizing mutation
Cohort 6 EGFR sensitizing mutation
Cohort 7 EGFR 19del or L858R Mutation
Cohort 8 EGFR 19del or L858R Mutation
SKB264 (Dose Level 1) + Pembrolizumab
SKB264 (Dose Level 2) + Pembrolizumab
SKB264 (Dose Level 3) + Pembrolizumab + Carboplatin
SKB264 (Dose Level 1) + Pembrolizumab + Carboplatin
SKB264 (Dose Level 3) + Carboplatin
SKB264 (Dose Level 1) + Carboplatin
SKB264 (Dose Level 1) + Osimertinib
SKB264 (Dose Level 2) + Osimertinib