Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06847334

Not yet recruiting

A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

Interventional

Phase 3

Sponsor: Shanghai Henlius

Last Updated: March 25, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

This is a multicentre, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs. Keytruda®( US- and EU-sourced) in the first-line treatment of advanced non-squamous non-small cell lung cancer.

Show Detailed Description

Treatment Category

Other Drugs

Required Mutations

None

Trial Started

April 27, 2025

Last Updated by Sponsor

March 25, 2025

Estimated Completion

April 9, 2027

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Eligibility

Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC.

* Without any tumor activating EGFR mutation or ALK or ROS1 gene rearrangement.

* Have not received prior systemic treatment for their advanced/metastatic NSCLC.

* At least one measurable lesion as assessed by IRRC based on RECIST v1.1.

* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.

* Have adequate organ function.

Exclusion Criteria

* Subjects with NSCLC of other histopathological types, such as mixed adenosquamous carcinoma, and subjects with small cell lung cancer or neuroendocrine carcinoma.

* Subjects with other active malignancies within 5 years or at the same time prior to screening.

* Active central nervous system metastases.

* Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity.

* Known active or suspected autoimmune diseases.

* History of immunodeficiency, including HIV antibody positive, active hepatitis B; or hepatitis C virus infections.

* Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before screening.

* Pregnant or breastfeeding female.

* The investigator has a clear reason to believe that participation in this study would be detrimental to the subject.

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Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingDouble

Number to Enroll772

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Recombinant anti-programmed death receptor-1- humanized antibody injection developed by Shanghai Henlius Biotech, Inc.

Interventions:

HLX17
US-sourced Keytruda®
EU-sourced Keytruda®

Outcome Measures

Primary Outcome Measures

Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d)Up to Day 21

Area under the serum concentration-time curve within a dosing interval at steady state (AUCss)Up to 1 year

Best Objective Response Rate (BORR) assessed by Independent Radiology Review Committee (IRRC) based on RECIST v1.1up to week 24

Secondary Outcome Measures

Overall survival (OS)Up to 1 year

Adverse events (AEs)Up to Month 15

Serious adverse events (SAEs)Up to Month 15

Incidence of anti-drug antibodies (ADAs).Up to 1 year

Incidence of neutralizing antibodies (NAbs).Up to 1 year

Maximum serum drug concentration (Cmax) after the first doseUp to Day 21

Trough serum drug concentration (Ctrough) after the first doseUp to Day 21

Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) after the first doseUp to Day 21

Area under the serum concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) after the first doseUp to Day 21

Time to reach maximum serum drug concentration (Tmax) after the first doseUp to Day 21

Elimination half life (t1/2) after the first doseUp to Day 21

Volume of distribution during terminal phase (Vz) after the first doseUp to Day 21

Total clearance (CL) after the first doseUp to Day 21

Mean residence time (MRT) after the first doseUp to Day 21

Maximum serum drug concentration at steady-state (Cmax, ss)Up to 1 year

Trough serum drug concentration at steady-state (Ctrough, ss)Up to 1 year

Average serum drug concentration at steady-state (Cave, ss)Up to 1 year

Time to reach maximum serum drug concentration at steady-state (Tmax, ss)Up to 1 year

Elimination half life at steady-state (t1/2, ss)Up to 1 year

Volume of distribution at steady-state (Vss)Up to 1 year

Total clearance at steady-state (CLss)Up to 1 year

Accumulation ratio of AUC (Rac(AUC))Up to 1 year

Accumulation ratio of Cmax (Rac(Cmax))Up to 1 year

Objective response rate (ORR) assessed by IRRC (based on RECIST v1.1)Up to Week 24

Objective response rate (ORR) assessed by Investigator (based on RECIST v1.1)Up to Week 48

Duration of response (DOR) assessed by the investigator (based on RECIST v1.1)Up to Week 48

Time to response (TTR) assessed by the investigator (based on RECIST v1.1)Up to Week 48

Progression free survival (PFS) assessed by the investigator (based on RECIST v1.1)Up to Week 48

Progression free survival rate (PFSR) assessed by the investigator (based on RECIST v1.1)Up to Week 48