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

Phase 2

Active, not recruiting

• Conditions: Advanced Non-small Cell Lung Cancer
• Interventions: Drug: AK104; Drug: Docetaxel

• Registration Number: NCT05215067
• Lead Sponsor: Akeso

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Study Start: 2022-03-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AK104 plus Docetaxel	AK104	AK104 RP2D + Docetaxel 75mg/m\^2 every 3 weeks until progressive disease or unacceptable toxicity.
AK104 plus Docetaxel	Docetaxel	AK104 RP2D + Docetaxel 75mg/m\^2 every 3 weeks until progressive disease or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Number of patients with Adverse Events (AEs)	Up to approximately 2 years	Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
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
Duration of Response (DOR)	Up to approximately 2 years
Progression free survival (PFS)	Up to approximately 2 years
Time to response (TTR)	Up to approximately 2 years
Antidrug antibodies (ADA) of AK104	Up to approximately 2 years
Disease control rate (DCR)	Up to approximately 2 years

Trial Locations

Locations (1)

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China