Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT06847334

Ne recrute pas encore

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

Interventionnel

Phase 3

Sponsor: Shanghai Henlius

Dernière synchronisation : 25 mars 2025
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

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.

Afficher la description détaillée

Catégorie de traitement

Autres médicaments

Mutations requises

Aucun

Essai commencé

27 avril 2025

Dernière mise à jour par le sponsor

25 mars 2025

Achèvement estimé

9 avril 2027

Contact de l'étude

Éligibilité

Critères d'inclusion

* 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.

Critères d'exclusion

* 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.

Pensez-vous que cet essai apparaît incorrectement ?

Détails de la conception

AllocationRandomized

Modèle d'interventionParallel Assignment

MasquageDouble

Nombre à inscrire772

Bras et interventions

Bras

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®

Mesures des résultats

Mesures des résultats primaires

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

Mesures des résultats secondaires

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

Overall survival rate (OSR)Up to 1 year

Mettre l'essai en favori

Partager l'essai

Télécharger l'essai

Pensez-vous que cet essai apparaît incorrectement ?

Signaler l'essai

Télécharger l'essai

Sites d'essai

Aucune donnée

No matching sites found.

Loading Maps...