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

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05215067
• Other study ID #: AK104-215
• Status: Recruiting
• Phase: Phase 2
• Start date: March 9, 2022
• Est. completion date: March 20, 2024

Study information

• Verified date: March 2022
• Source: Akeso
• Contact: Weifeng Song, MD
• Phone: +86(0760)89873999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 20, 2024
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• AK104
IV infusion,Specified dose on specified days
• Docetaxel
IV infusion,Specified dose on specified days

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)		Up to approximately 2 years
Secondary	Number of patients with Adverse Events (AEs)	Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs	Up to approximately 2 years
Secondary	Disease control rate (DCR)		Up to approximately 2 years
Secondary	Duration of Response (DOR)		Up to approximately 2 years
Secondary	Time to response (TTR)		Up to approximately 2 years
Secondary	Progression free survival (PFS)		Up to approximately 2 years
Secondary	Overall survival (OS)		Up to approximately 2 years
Secondary	Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104		Up to approximately 2 years
Secondary	Antidrug antibodies (ADA) of AK104		Up to approximately 2 years