Status:
ACTIVE_NOT_RECRUITING
A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Akeso
Conditions:
Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 dise...
Eligibility Criteria
Inclusion
- 18 to 75 years old.
- Have a life expectancy of at least 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.
- Has radiographic progression after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody (mAb) administered.
- No known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.
- Has at least 1 measurable lesion per RECIST 1.1 assessed by investigator.
- Has adequate organ function.
Exclusion
- Undergone major surgery within 30 days prior to the first dose of study treatment.
- Active central nervous system (CNS) metastases.
- History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
- Active Hepatitis B or Hepatitis C.
- Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
- Has received treatment with docetaxel.
- History of severe bleeding tendency or coagulation disorder.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05215067
Start Date
March 9 2022
End Date
June 30 2026
Last Update
March 12 2025
Active Locations (1)
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1
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009