Comparing CT-P51 and Keytruda for treating metastatic lung cancer
A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P51 and Keytruda in Combination With Platinum-Pemetrexed Chemotherapy in Patients With Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer
This study is testing whether a new treatment called CT-P51 works better than Keytruda for people with untreated metastatic lung cancer when used with chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 606 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Celltrion Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tbilisi) |
| Trial ID | NCT06939595 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial aims to evaluate the efficacy and safety of CT-P51 compared to the EU-approved Keytruda when used alongside platinum pemetrexed chemotherapy in patients with previously untreated metastatic non-squamous non-small cell lung cancer (nsNSCLC). The study will enroll participants who have not received any prior systemic anti-cancer therapy and have measurable lesions. The trial will assess how well these two treatments perform in managing the disease and their safety profiles.
Who should consider this trial
Good fit: Ideal candidates are patients with Stage IV non-squamous NSCLC who have not undergone any prior systemic therapy.
Not a fit: Patients with predominantly squamous cell histology NSCLC or those with hypersensitivity to study drugs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with metastatic lung cancer.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stage IV, non squamous NSCLC * Have not received any prior systemic anti-cancer therapy for metastatic NSCLC * Have at least 1 measurable lesion per RECIST version 1.1 Exclusion Criteria: * Have predominantly squamous cell histology NSCLC. * Hypersensitivity or contraindication to any component of the study drug, pemetrexed and cisplatin or carboplatin
Where this trial is running
Tbilisi
- ltd "Institute of Clinical Oncology" — Tbilisi, Georgia (Recruiting)
Study contacts
- Study coordinator: Jaeyoung Jang
- Email: jaeyoung.jang@celltrion.com
- Phone: +82 32 850 5769
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.