Back to results

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

Primary Purpose

Advanced Non-small Cell Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

AK104

Docetaxel

About this trial

This is an interventional treatment trial for Advanced Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Jiangsu Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AK104 plus Docetaxel

Arm Description

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

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Secondary Outcome Measures

Number of patients with Adverse Events (AEs)

Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs

Disease control rate (DCR)

Duration of Response (DOR)

Time to response (TTR)

Progression free survival (PFS)

Overall survival (OS)

Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104

Antidrug antibodies (ADA) of AK104

Full Information

NCT ID

NCT05215067

First Posted

January 18, 2022

Last Updated

March 24, 2022

Sponsor

Akeso

1. Study Identification

Unique Protocol Identification Number

NCT05215067

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 9, 2022 (Actual)

Primary Completion Date

March 20, 2023 (Anticipated)

Study Completion Date

March 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akeso

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AK104 plus Docetaxel

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AK104

Intervention Description

IV infusion,Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

IV infusion,Specified dose on specified days

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Time Frame

Up to approximately 2 years

Secondary Outcome Measure Information:

Title

Number of patients with Adverse Events (AEs)

Description

Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs

Time Frame

Up to approximately 2 years

Title

Disease control rate (DCR)

Time Frame

Up to approximately 2 years

Title

Duration of Response (DOR)

Time Frame

Up to approximately 2 years

Title

Time to response (TTR)

Time Frame

Up to approximately 2 years

Title

Progression free survival (PFS)

Time Frame

Up to approximately 2 years

Title

Overall survival (OS)

Time Frame

Up to approximately 2 years

Title

Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104

Time Frame

Up to approximately 2 years

Title

Antidrug antibodies (ADA) of AK104

Time Frame

Up to approximately 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weifeng Song, MD

Phone

+86(0760)89873999

clinicaltrials@akesobio.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jifeng Feng, MD

Phone

025-83284707

fjif@vip.sina.com

Facility Information:

Facility Name

Jiangsu Cancer Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jifeng Feng, MD

Phone

025-83284707

fjif@vip.sina.com

First Name & Middle Initial & Last Name & Degree

Feng Jifeng, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs