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

• Status: Not yet recruiting
• Trial end date: 2025-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akeso
• Treatments: Carboplatin

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.