A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer
NCT ID: NCT05215067
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
44 participants
INTERVENTIONAL
2022-03-09
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AK104 plus Docetaxel
AK104 RP2D + Docetaxel 75mg/m\^2 every 3 weeks until progressive disease or unacceptable toxicity.
AK104
IV infusion,Specified dose on specified days
Docetaxel
IV infusion,Specified dose on specified days
Interventions
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AK104
IV infusion,Specified dose on specified days
Docetaxel
IV infusion,Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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AK104-215
Identifier Type: -
Identifier Source: org_study_id
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