Clinical Trials/NCT05990127

NCT05990127

Not yet recruiting

Phase 3

A Randomized, Double-blind, Phase III Trial to Compare the Efficacy and Safety of AK104 Combined With Chemotherapy to Tislelizumab Combined With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer (NSCLC)

Akeso62 sites in 1 country642 target enrollmentNovember 14, 2023

ConditionsLocally Advanced or Metastatic NSCLC

InterventionsPaclitaxel AK104 carboplatin Pemetrexed Tislelizumab

DrugsAK104 Tislelizumab carboplatin Pemetrexed Paclitaxel

Overview

Phase: Phase 3
Intervention: Paclitaxel
Conditions: Locally Advanced or Metastatic NSCLC
Sponsor: Akeso
Enrollment: 642
Locations: 62
Primary Endpoint: Overall Survival(OS)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS < 1%.

Registry

clinicaltrials.gov

Start Date

November 14, 2023

End Date

November 28, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
•Aged ≥18 years when the subject signed the informed consent.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Life expectancy ≥ 3 months.
•Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition).
•No prior systemic therapy for advanced or metastatic NSCLC was received.
•PD-L1 TPS \< 1%.
•No EGFR sensitive mutations or ALK gene translocation alterations.

Exclusion Criteria

•Histologically confirmed small cell lung cancer (SCLC).
•NSCLC with driver gene mutations for approved targeted drug indications.
•Active central nervous system (CNS) metastases were present.
•Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose.
•Active malignant tumors within the past 5 years, except for tumors in this study and scured local tumors.
•Pregnant or lactating women.
•Clinically significant cardiovascular or cerebrovascular disease.
•Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to all investigational drugs or any of their components.
•Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.
•Known active pulmonary tuberculosis.

Arms & Interventions

Tislelizumab arm

Intervention: Paclitaxel

AK104 arm

Intervention: AK104

AK104 arm

Intervention: carboplatin

AK104 arm

Intervention: Pemetrexed

AK104 arm

Intervention: Paclitaxel

Tislelizumab arm

Intervention: Tislelizumab

Tislelizumab arm

Intervention: carboplatin

Tislelizumab arm

Intervention: Pemetrexed

Outcomes

Primary Outcomes

Overall Survival(OS)

Time Frame: Through Database Cutoff Date (Up to approximately 39 months)

OS is defined as the time from randomization to death due to any cause.

Progression-Free Survival(PFS) by investigator(INV)

Time Frame: Through Database Cutoff Date (Up to approximately 39 months)

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1

Secondary Outcomes

Antidrug antibodies (ADA) of AK104(Through Database Cutoff Date (Up to approximately 39 months))
Progression-Free Survival(PFS) by Blind independent center review(BIRC)(Through Database Cutoff Date (Up to approximately 39 months))
Objective response rate (ORR) was assessed by INV(Through Database Cutoff Date (Up to approximately 39 months))
Disease control rate (DCR) was assessed by INV(Through Database Cutoff Date (Up to approximately 39 months))
Time to response (TTR) was assessed by INV(Through Database Cutoff Date (Up to approximately 39 months))
Duration of response (DOR) was assessed by INV(Through Database Cutoff Date (Up to approximately 39 months))
Objective response rate (ORR) was assessed by BIRC(Through Database Cutoff Date (Up to approximately 39 months))
Disease control rate (DCR) was assessed BIRC(Through Database Cutoff Date (Up to approximately 39 months))
Time to response (TTR) was assessed by BIRC(Through Database Cutoff Date (Up to approximately 39 months))
Duration of response (DOR) was assessed by BIRC(Through Database Cutoff Date (Up to approximately 39 months))
The number of subjects experiencing adverse events (AEs)(Through Database Cutoff Date (Up to approximately 39 months))
Pharmacokinetic(Through Database Cutoff Date (Up to approximately 39 months))
Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Through Database Cutoff Date (Up to approximately 39 months))
Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 module (EORTC QLQ-LC29)(Through Database Cutoff Date (Up to approximately 39 months))