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NCT02767804 · ClinicalTrials.gov registry record · Phase 3
eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Xcovery Holdings.
- Active
- Registry status
- Phase 3
- Development phase
- 290
- Enrollment target
- 20
- Study locations
NCT02767804: Active Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Xcovery Holdings.
NCT02767804 is a Phase 3 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Xcovery Holdings. The registered enrollment target is 290 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02767804, a Phase 3 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Xcovery Holdings.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 290 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.
Primary Outcome
as assessed by independent radiology review based on RECIST v. 1.1 criteria
Conditions Studied
Interventions
- DRUG X-396 (ensartinib)
- DRUG crizotinib
Study Locations (20)
Other
- Sanatorio Parque S.A. - Rosario
- Chris O Brien Lifehouse - Camperdown
- Catholic University of Louvain (UCL) - Site Mont Godinne - Yvoir
- Hospital Haroldo Juaçaba - Instituto do Cancêr do Ceará - Fortaleza
- Fundacao do ABC Faculdade de Medicina do ABC - São Paulo
Beijing Municipality
- Beijing Chao Yang Hospital - Beijing
- Peking Union Medical College Hospital - Beijing
- Peking University Cancer Hospital - Beijing
- Beijing Chest Hospital,Capital Medical University - Beijing
New South Wales
- Border Medical Oncology Research Unit - Albury
- Chris O'Brien Lifehouse - Camperdown
São Paulo
- Instituto do Câncer do Estado de São Paulo - São Paulo
- Hospital de Câncer de Barretos - Fundação Pio XII - São Paulo
Florida
- Moffitt Cancer Center - Tampa
Georgia
- University Cancer & Blood Center - Athens
Missouri
- Washington University School of Medicine - St Louis
Oregon
- Providence Portland Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2016-06 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What the registry record for NCT02767804 still lists
NCT02767804 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which X-396 (ensartinib) is the first listed.
NCT02767804 names 20 study sites across 11 states, led by Other, Beijing Municipality, New South Wales.
Frequently Asked Questions
What is clinical trial NCT02767804 about?
NCT02767804 is a clinical study titled "eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients". The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.
What is the current status of trial NCT02767804?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 290 participants. The study started on 2016-06. Estimated completion is 2025-12-31.
What conditions does trial NCT02767804 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT02767804?
The interventions under investigation include: X-396 (ensartinib) (DRUG), crizotinib (DRUG).
Who is sponsoring clinical trial NCT02767804?
This trial is sponsored by Xcovery Holdings, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02767804 being conducted?
This trial has 20 study locations across Florida, Georgia, Missouri, Oregon, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02767804's enrollment target sits among peer trials
290 129th of 454 higher than 326 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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