NCT06847334Not yet recruitingPhase 3
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 · Last updated 26 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 772 (estimated)
- First submitted
- 20 Feb 2025
- Start date
- 27 Apr 2025
- Primary completion date
- 9 Apr 2027
- Lead sponsor
- Shanghai Henlius Biotech
- Diseases
- Lung cancer
- NCT number
- NCT06847334
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 772
- From 27 Apr 2025 to the primary completion date, 9 Apr 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with other active malignancies within 5 years or at the same time prior to screening.
- Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before screening.
Other illness
- Subjects with NSCLC of other histopathological types, such as mixed adenosquamous carcinoma, and subjects with small cell lung cancer or neuroendocrine carcinoma.
- 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.
Other
- Active central nervous system metastases.
- Pregnant or breastfeeding female.
- The investigator has a clear reason to believe that participation in this study would be detrimental to the subject.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.