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

Advanced Squamous Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840016
• Other study ID #: AK112-306
• Status: Recruiting
• Phase: Phase 3
• Start date: August 17, 2023
• Est. completion date: December 20, 2025

Study information

• Verified date: August 2023
• Source: Akeso
• Contact: Weifeng Song, MD
• Phone: +86(0760)89873999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: December 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• AK112, Carboplatin, Paxlitaxel
IV infusion,Specified dose on specified days
• Tislelizumab, Carboplatin, Paxlitaxel
IV infusion,Specified dose on specified days

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to approximately 2 years
Secondary	OS	Overall Survival (OS) is defined as the time from the start of treatment with AK112 until death due to any cause.	Up to approximately 2 years
Secondary	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.	Up to approximately 2 years
Secondary	DoR assessed by IRRC per RECIST v1.1	Duration of response (DoR) assessed according to RECIST v1.1	Up to approximately 2 years
Secondary	DCR assessed by IRRC per RECIST v1.1	Disease control rate (DCR) assessed according to RECIST v1.1.	Up to approximately 2 years
Secondary	TTR assessed by IRRC per RECIST v1.1	Time to response (TTR) is defined as the time to response base on RECIST v1.1.	Up to approximately 2 years
Secondary	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).	Up to approximately 2 years
Secondary	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.	Up to approximately 2 years
Secondary	DoR assessed by the investigator per RECIST v1.1	Duration of response (DoR) assessed according to RECIST v1.1.	Up to approximately 2 years
Secondary	DCR assessed by the investigator per RECIST v1.1	Disease control rate (DCR) assessed according to RECIST v1.1.	Up to approximately 2 years
Secondary	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.	Up to approximately 2 years
Secondary	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.	Up to approximately 2 years
Secondary	ADA	Number of subjects with detectable anti-drug antibodies (ADA).	Up to approximately 2 years
Secondary	Cmax and Cmin	AK112 serum drug concentrations in subjects at different time points after AK112 administration	Up to approximately 2 years
Secondary	PD-L1 expression	The correlationship between PD-L1 expression and efficacy.	Up to approximately 2 years