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

Akeso

Status and phase: Active, not recruiting; Phase 3

Conditions: Advanced Squamous Non Small Cell Lung Cancer

Treatments: Drug: AK112, Carboplatin, Paxlitaxel; Drug: Tislelizumab, Carboplatin, Paxlitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05840016

AK112-306

Details and patient eligibility

About

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.

Enrollment: 532 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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532 participants in 2 patient groups

Experimental: AK112 in Combination With Paclitaxel Plus Carboplatin

Experimental group

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.

Treatment:

Drug: AK112, Carboplatin, Paxlitaxel

Active Comparator: Tislelizumab in Combination With Paclitaxel Plus Carboplatin

Active Comparator group

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.

Treatment:

Drug: Tislelizumab, Carboplatin, Paxlitaxel