Clinical trial NCT05840016: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Advanced Squamous Non Small Cell Lung Cancer
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 and ≤75 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 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.

Primary outcomes:
measure: PFS assessed by IRRC per RECIST v1.1
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: OS
timeFrame: Up to approximately 2 years
measure: ORR assessed by IRRC per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: DoR assessed by IRRC per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: DCR assessed by IRRC per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: TTR assessed by IRRC per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: PFS assessed by investigator per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: ORR assessed by the investigator per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: DoR assessed by the investigator per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: DCR assessed by the investigator per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: TTR assessed by the investigator per RECIST v1.1
timeFrame: Up to approximately 2 years
measure: AE
timeFrame: Up to approximately 2 years
measure: ADA
timeFrame: Up to approximately 2 years
measure: Cmax and Cmin
timeFrame: Up to approximately 2 years
measure: PD-L1 expression
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: