Advanced Non-small Cell Lung Cancer
Conditions
Brief summary
Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody
Interventions
DRUGAK104
IV infusion,Specified dose on specified days
DRUGDocetaxel
IV infusion,Specified dose on specified days
Sponsors
Akeso
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 75 years old. 2. Have a life expectancy of at least 3 months. 3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC. 5. Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered. 6. No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations. 7. Has at least 1 measurable lesion per RECIST 1.1 assessed by investigator. 8. Has adequate organ function.
Exclusion criteria
1. Undergone major surgery within 30 days prior to the first dose of study treatment. 2. Active central nervous system (CNS) metastases. 3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs). 4. Active Hepatitis B or Hepatitis C. 5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity. 6. Has received treatment with docetaxel. 7. History of severe bleeding tendency or coagulation disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | Up to approximately 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Adverse Events (AEs) | Up to approximately 2 years | Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs |
| Disease control rate (DCR) | Up to approximately 2 years | — |
| Duration of Response (DOR) | Up to approximately 2 years | — |
| Time to response (TTR) | Up to approximately 2 years | — |
| Progression free survival (PFS) | Up to approximately 2 years | — |
| Overall survival (OS) | Up to approximately 2 years | — |
| Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104 | Up to approximately 2 years | — |
| Antidrug antibodies (ADA) of AK104 | Up to approximately 2 years | — |
Countries
China
Outcome results
None listed