Clinical trial · Interventional
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
A Multicentre, Randomized, Double-Blind, Parallel-Controlled Integrated Phase I/III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Profile of HLX17 Vs. Keytruda® (US-sourced Keytruda® and EU-sourced Keytruda®) in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Squamous Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EU-sourced Keytruda® | Drug | — | UNRESOLVED |
| HLX17 | Drug | — | UNRESOLVED |
| US-sourced Keytruda® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- HLX17 group
- description
- Recombinant anti-programmed death receptor-1- humanized antibody injection developed by Shanghai Henlius Biotech, Inc.
- interventionNames
- Drug: HLX17
- type
- ACTIVE_COMPARATOR
- label
- US-sourced Keytruda® group
- description
- US-sourced Keytruda
- interventionNames
- Drug: US-sourced Keytruda®
- type
- ACTIVE_COMPARATOR
- label
- EU-sourced Keytruda® group
- description
- EU-sourced Keytruda
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available