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AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer

Primary Purpose

Advanced Squamous Non Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
AK112, Carboplatin, Paxlitaxel
Tislelizumab, Carboplatin, Paxlitaxel
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Squamous Non Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). ≥18 years old(at the time consent is obtained). Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Has a life expectancy of at least 3 months. Has a histologically or cytologically confirmed diagnosis of squamous NSCLC. Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC]). Has no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Has adequate organ function. Exclusion Criteria: Histological diagnosis of non-squamous NSCLC. Has EGFR-sensitive mutations or ALK gene translocations. Known ROS1 rearrangement, MET exon 14 skipping mutation, or RET gene fusion positivite. 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 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). History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. 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

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: AK112 in Combination With Paclitaxel Plus Carboplatin

Active Comparator: Tislelizumab in Combination With Paclitaxel Plus Carboplatin

Arm Description

AK112 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Carboplatin will be administered at AUC5, Q3W, intravenously (IV) for 4 cycles. Paclitaxel will be administered at 175 mg/m2, Q3W, intravenously (IV) for 4 cycles.

Tislelizumab will be administered at a dose of 200 mg intravenously (IV) every three weeks (Q3W). Carboplatin will be administered at AUC5, Q3W, intravenously (IV) for 4 cycles. Paclitaxel will be administered at 175 mg/m2, Q3W, intravenously (IV) for 4 cycles.

Outcomes

Primary Outcome Measures

PFS assessed by IRRC per RECIST v1.1
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).

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.
ORR assessed by IRRC per RECIST v1.1
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
DoR assessed by IRRC per RECIST v1.1
Duration of response (DoR) assessed according to RECIST v1.1
DCR assessed by IRRC per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
TTR assessed by IRRC per RECIST v1.1
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
PFS assessed by investigator per RECIST v1.1
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
ORR assessed by the investigator per RECIST v1.1
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
DoR assessed by the investigator per RECIST v1.1
Duration of response (DoR) assessed according to RECIST v1.1.
DCR assessed by the investigator per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
TTR assessed by the investigator per RECIST v1.1
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
AE
An AE 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.
ADA
Number of subjects with detectable anti-drug antibodies (ADA).
Cmax and Cmin
AK112 serum drug concentrations in subjects at different time points after AK112 administration
PD-L1 expression
The correlationship between PD-L1 expression and efficacy.

Full Information

First Posted
April 21, 2023
Last Updated
August 22, 2023
Sponsor
Akeso
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1. Study Identification

Unique Protocol Identification Number
NCT05840016
Brief Title
AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
Official Title
A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Combined With Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2023 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
December 20, 2025 (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

5. Study Description

Brief Summary
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or stage IV squamous non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 combined with chemotherapy versus Tislelizumab combined with chemotherapy in patients with advanced squamous NSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Squamous Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
396 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: AK112 in Combination With Paclitaxel Plus Carboplatin
Arm Type
Experimental
Arm Description
AK112 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Carboplatin will be administered at AUC5, Q3W, intravenously (IV) for 4 cycles. Paclitaxel will be administered at 175 mg/m2, Q3W, intravenously (IV) for 4 cycles.
Arm Title
Active Comparator: Tislelizumab in Combination With Paclitaxel Plus Carboplatin
Arm Type
Active Comparator
Arm Description
Tislelizumab will be administered at a dose of 200 mg intravenously (IV) every three weeks (Q3W). Carboplatin will be administered at AUC5, Q3W, intravenously (IV) for 4 cycles. Paclitaxel will be administered at 175 mg/m2, Q3W, intravenously (IV) for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
AK112, Carboplatin, Paxlitaxel
Intervention Description
IV infusion,Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Tislelizumab, Carboplatin, Paxlitaxel
Intervention Description
IV infusion,Specified dose on specified days
Primary Outcome Measure Information:
Title
PFS assessed by IRRC per RECIST v1.1
Description
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).
Time Frame
Up to approximately 2 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 approximately 2 years
Title
ORR assessed by IRRC 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 approximately 2 years
Title
DoR assessed by IRRC per RECIST v1.1
Description
Duration of response (DoR) assessed according to RECIST v1.1
Time Frame
Up to approximately 2 years
Title
DCR assessed by IRRC per RECIST v1.1
Description
Disease control rate (DCR) assessed according to RECIST v1.1.
Time Frame
Up to approximately 2 years
Title
TTR assessed by IRRC 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 approximately 2 years
Title
PFS assessed by investigator per RECIST v1.1
Description
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
Time Frame
Up to approximately 2 years
Title
ORR assessed by the investigator 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 approximately 2 years
Title
DoR assessed by the investigator per RECIST v1.1
Description
Duration of response (DoR) assessed according to RECIST v1.1.
Time Frame
Up to approximately 2 years
Title
DCR assessed by the investigator per RECIST v1.1
Description
Disease control rate (DCR) assessed according to RECIST v1.1.
Time Frame
Up to approximately 2 years
Title
TTR assessed by the investigator 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 approximately 2 years
Title
AE
Description
An AE 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 approximately 2 years
Title
ADA
Description
Number of subjects with detectable anti-drug antibodies (ADA).
Time Frame
Up to approximately 2 years
Title
Cmax and Cmin
Description
AK112 serum drug concentrations in subjects at different time points after AK112 administration
Time Frame
Up to approximately 2 years
Title
PD-L1 expression
Description
The correlationship between PD-L1 expression and efficacy.
Time Frame
Up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). ≥18 years old(at the time consent is obtained). Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Has a life expectancy of at least 3 months. Has a histologically or cytologically confirmed diagnosis of squamous NSCLC. Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer [AJCC]). Has no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Has adequate organ function. Exclusion Criteria: Histological diagnosis of non-squamous NSCLC. Has EGFR-sensitive mutations or ALK gene translocations. Known ROS1 rearrangement, MET exon 14 skipping mutation, or RET gene fusion positivite. 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 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). History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. 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
First Name & Middle Initial & Last Name or Official Title & Degree
Shun Lu, MD
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shun Lu, MD

12. IPD Sharing Statement

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AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer

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