A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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

Official Title
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A Phase II Trial of AK104 in Combination With Docetaxel in Subjects With Advanced Non-Small Cell Lung Cancer and Progressive Disease After Platinum Doublet Chemotherapy and Treatment With One Prior Anti-PD-1/PD-L1 Monoclonal Antibody (mAb)

Conditions
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Advanced Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: AK104
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK104 plus Docetaxel<br>AK104 RP2D + Docetaxel 75mg/m^2 every 3 weeks until progressive disease or unacceptable toxicity. | Drug: AK104<br>* IV infusion,Specified dose on specified days<br>Drug: Docetaxel<br>* IV infusion,Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Adverse Events (AEs) | Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs | Up to approximately 2 years | 
| 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 |