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

Launched by AKESO · Apr 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AK112, which is being tested in combination with chemotherapy for patients with advanced squamous non-small cell lung cancer (NSCLC). The aim is to see how well this new treatment works and how safe it is compared to another treatment called Tislelizumab, also combined with chemotherapy. The trial is open to adults aged 18 and older who have been diagnosed with stage IIIB/C or stage IV squamous NSCLC and have a good performance status, meaning they can carry out daily activities without much difficulty.

Eligible participants will need to provide written consent and meet certain health criteria, such as having a life expectancy of at least three months and no prior treatment for their lung cancer. Those who join the study can expect regular visits for treatment and monitoring of their health throughout the trial. It’s important to know that participants with certain health conditions or previous treatments may not be able to join. If you or a loved one is considering participating, discussing this trial with a healthcare provider can help determine if it's a suitable option.

Gender

ALL

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.