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

NCT06847334 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HLX17-NSCLC301
• Study Type: interventional
• Target: 772
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Keywords

Keytruda biosimilar

Outcome Measures

Primary Outcomes (3)

• 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 v1.1

  up to week 24

Secondary Outcomes (30)

• Maximum serum drug concentration (Cmax) after the first dose

  Up to Day 21

• Trough serum drug concentration (Ctrough) after the first dose

  Up to Day 21

• Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) after the first dose

  Up 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 dose

  Up to Day 21

• Time to reach maximum serum drug concentration (Tmax) after the first dose

  Up to Day 21

Study Arms (3)

HLX17 group

EXPERIMENTAL

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

Drug: HLX17

US-sourced Keytruda® group

ACTIVE COMPARATOR

US-sourced Keytruda

Drug: US-sourced Keytruda®

EU-sourced Keytruda® group

ACTIVE COMPARATOR

EU-sourced Keytruda

Drug: EU-sourced Keytruda®

Interventions

HLX17 DRUG

HLX17 will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.

HLX17 group

US-sourced Keytruda® DRUG

US-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed. After 24 weeks, all subjects in the US-Keytruda® group will receive HLX17 in combination with Pemetrexed until loss of clinical benefit or up to 1 year.

US-sourced Keytruda® group

EU-sourced Keytruda® DRUG

EU-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.

EU-sourced Keytruda® group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Design

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

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 26, 2025
• Study Start: April 27, 2025
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): January 24, 2028
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share