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AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer

Primary Purpose

Advanced Non-small-cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
AK112
AK104
caboplatin
paclitaxel
pemetrexed
Docetaxel
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

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: Has a histologically or cytologically confirmed diagnosis of NSCLC. Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC 8th]). 18-75 years old (at the time consent is obtained). Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue. Has a life expectancy of at least 3 months. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team. Has no EGFR-sensitive mutations or ALK gene translocations. Has adequate organ function. Has recovered from the effects of any prior radiotherapy or surgery. All female and male subjects of reproductive potential must agree to use an effective method of contraception, during and for 120 days after the last dose of study treatment. Exclusion Criteria: Has any histologically small cell carcinoma component. Is currently participating in a study of an investigational agent or using an investigational device. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment. Has undergone major surgery within 30 days of Study Day 1. Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Has known active central nervous system (CNS) metastases. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Has an active infection requiring systemic therapy. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Has a history of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. Has received a live virus vaccine within 30 days of the planned first dose of study therapy. Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting
  • Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

AK112, AK104 dose 1 plus caboplatin and paclitaxel

AK112, AK104 dose 1 plus caboplatin and pemetrexed

AK112, AK104 dose 2 plus caboplatin and paclitaxel

AK112, AK104 dose 2 plus caboplatin and pemetrexed

AK112 plus AK104

AK112, AK104 plus docetaxel

Arm Description

Outcomes

Primary Outcome Measures

Safety reflected by AE
Safety will be reflected by AE, which is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
ORR per RECIST v1.1
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

Secondary Outcome Measures

OS
Overall Survival (OS) is defined as the time from the start of treatment with AK112 until death due to any cause.
DoR per RECIST v1.1
Duration of response (DoR) assessed according to RECIST v1.1.
DCR per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
TTR per RECIST v1.1
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
PFS per RECIST v1.1
Progression-free survival (PFS) is defined as the time from the date of Initial administration till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
AK112 serum concentration
The serum concentration of AK112 of individual subjects at different time points.
AK104 serum concentration
The serum concentration of AK104 of individual subjects at different time points.
ADA
Number of subjects with detectable anti-drug antibodies (ADA).
PD-L1 expression
The correlationship between PD-L1 expression and effecacy.
ctDNA
The correlationship between ctDNA detection and effecacy.

Full Information

First Posted
May 17, 2023
Last Updated
September 17, 2023
Sponsor
Akeso
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1. Study Identification

Unique Protocol Identification Number
NCT05904379
Brief Title
AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
Official Title
A Phase Ib/II Clinical Trial of AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
January 31, 2027 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is a Phase Ib/II study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and AK104 with or without chemothorapy in subjects with advanced NSCLC.

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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AK112, AK104 dose 1 plus caboplatin and paclitaxel
Arm Type
Experimental
Arm Title
AK112, AK104 dose 1 plus caboplatin and pemetrexed
Arm Type
Experimental
Arm Title
AK112, AK104 dose 2 plus caboplatin and paclitaxel
Arm Type
Experimental
Arm Title
AK112, AK104 dose 2 plus caboplatin and pemetrexed
Arm Type
Experimental
Arm Title
AK112 plus AK104
Arm Type
Experimental
Arm Title
AK112, AK104 plus docetaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AK112
Intervention Description
Subjects receive AK112 intravenously.
Intervention Type
Drug
Intervention Name(s)
AK104
Intervention Description
Subjects receive AK104 intravenously.
Intervention Type
Drug
Intervention Name(s)
caboplatin
Intervention Description
Subjects receive caboplatin intravenously.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
Subjects receive paclitaxel intravenously.
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Description
Subjects receive pemetrexed intravenously.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Subjects receive docetaxel intravenously.
Primary Outcome Measure Information:
Title
Safety reflected by AE
Description
Safety will be reflected by AE, which is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time Frame
Up to 2 approximately years
Title
ORR per RECIST v1.1
Description
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Time Frame
Up to 2 approximately years
Secondary Outcome Measure Information:
Title
OS
Description
Overall Survival (OS) is defined as the time from the start of treatment with AK112 until death due to any cause.
Time Frame
Up to 2 approximately years
Title
DoR per RECIST v1.1
Description
Duration of response (DoR) assessed according to RECIST v1.1.
Time Frame
Up to 2 approximately years
Title
DCR per RECIST v1.1
Description
Disease control rate (DCR) assessed according to RECIST v1.1.
Time Frame
Up to 2 approximately years
Title
TTR per RECIST v1.1
Description
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
Time Frame
Up to 2 approximately years
Title
PFS per RECIST v1.1
Description
Progression-free survival (PFS) is defined as the time from the date of Initial administration till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
Time Frame
Up to 2 approximately years
Title
AK112 serum concentration
Description
The serum concentration of AK112 of individual subjects at different time points.
Time Frame
Up to 2 approximately years
Title
AK104 serum concentration
Description
The serum concentration of AK104 of individual subjects at different time points.
Time Frame
Up to 2 approximately years
Title
ADA
Description
Number of subjects with detectable anti-drug antibodies (ADA).
Time Frame
Up to 2 approximately years
Title
PD-L1 expression
Description
The correlationship between PD-L1 expression and effecacy.
Time Frame
Up to 2 approximately years
Title
ctDNA
Description
The correlationship between ctDNA detection and effecacy.
Time Frame
Up to 2 approximately years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a histologically or cytologically confirmed diagnosis of NSCLC. Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC 8th]). 18-75 years old (at the time consent is obtained). Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue. Has a life expectancy of at least 3 months. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team. Has no EGFR-sensitive mutations or ALK gene translocations. Has adequate organ function. Has recovered from the effects of any prior radiotherapy or surgery. All female and male subjects of reproductive potential must agree to use an effective method of contraception, during and for 120 days after the last dose of study treatment. Exclusion Criteria: Has any histologically small cell carcinoma component. Is currently participating in a study of an investigational agent or using an investigational device. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment. Has undergone major surgery within 30 days of Study Day 1. Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Has known active central nervous system (CNS) metastases. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Has an active infection requiring systemic therapy. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Has a history of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. Has received a live virus vaccine within 30 days of the planned first dose of study therapy. Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weifeng Song, MD
Phone
+86(0760)89873999
Email
clinicaltrials@akesobio.com
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Fan, MD
Phone
+86-0571-88122222
Email
fanyun@zjcc.org.cn
First Name & Middle Initial & Last Name & Degree
Yun Fan, MD
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, MD
Phone
+86-021-65115006
Email
caicunzhoudr@163.com
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, MD

12. IPD Sharing Statement

Learn more about this trial

AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer

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