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

NCT ID: NCT05840016

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2026-12-31

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.

Conditions

Advanced Squamous Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: AK112 in Combination With Paclitaxel Plus Carboplatin

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.

Group Type: EXPERIMENTAL

AK112, Carboplatin, Paxlitaxel

Intervention Type: DRUG

IV infusion,Specified dose on specified days

Active Comparator: Tislelizumab in Combination With Paclitaxel Plus Carboplatin

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.

Group Type: ACTIVE_COMPARATOR

Tislelizumab, Carboplatin, Paxlitaxel

Intervention Type: DRUG

IV infusion,Specified dose on specified days

Interventions

AK112, Carboplatin, Paxlitaxel

IV infusion,Specified dose on specified days

Intervention Type: DRUG

Tislelizumab, Carboplatin, Paxlitaxel

IV infusion,Specified dose on specified days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Chest Hospital

Shanghai, , China

Countries

China

Other Identifiers

AK112-306

Identifier Type: -

Identifier Source: org_study_id