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

NCT05840016 | Active Not Recruiting Phase 3

• 1 other identifier: AK112-306
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• PFS assessed by IRRC per RECIST v1.1

  Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).

  Up to approximately 2 years

Secondary Outcomes (14)

• OS

  Up to approximately 2 years

• ORR assessed by IRRC per RECIST v1.1

  Up to approximately 2 years

• DoR assessed by IRRC per RECIST v1.1

  Up to approximately 2 years

• DCR assessed by IRRC per RECIST v1.1

  Up to approximately 2 years

• TTR assessed by IRRC per RECIST v1.1

  Up to approximately 2 years

Study Arms (2)

Experimental: AK112 in Combination With Paclitaxel Plus Carboplatin

EXPERIMENTAL

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.

Drug: AK112, Carboplatin, Paxlitaxel

Active Comparator: Tislelizumab in Combination With Paclitaxel Plus Carboplatin

ACTIVE COMPARATOR

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.

Drug: Tislelizumab, Carboplatin, Paxlitaxel

Interventions

AK112, Carboplatin, Paxlitaxel DRUG

IV infusion,Specified dose on specified days

Experimental: AK112 in Combination With Paclitaxel Plus Carboplatin

Tislelizumab, Carboplatin, Paxlitaxel DRUG

IV infusion,Specified dose on specified days

Active Comparator: Tislelizumab in Combination With Paclitaxel Plus Carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Interventions

Carboplatin; tislelizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: August 17, 2023
• Primary Completion: February 28, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

CN (1)