🏛️ Verified NIH Record • Updated 2025-10-08

eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients (NCT02767804)

Phase 3 Randomized Study Comparing X-396 (Ensartinib) to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Xcovery Holdings, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Moffitt Cancer Center — Tampa, Florida

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (72 Sites)

Showing the first 25 of 72 sites.

  • Moffitt Cancer Center — Tampa, Florida
  • University Cancer & Blood Center — Athens, Georgia
  • Washington University School of Medicine — St Louis, Missouri
  • Providence Portland Medical Center — Portland, Oregon
  • Sanatorio Parque S.A. — Rosario,
  • Border Medical Oncology Research Unit — Albury, New South Wales
  • Chris O'Brien Lifehouse — Camperdown, New South Wales
  • Chris O Brien Lifehouse — Camperdown,
  • Catholic University of Louvain (UCL) - Site Mont Godinne — Yvoir,
  • Instituto do Câncer do Estado de São Paulo — São Paulo, São Paulo
  • Hospital de Câncer de Barretos - Fundação Pio XII — São Paulo, São Paulo
  • Hospital Haroldo Juaçaba - Instituto do Cancêr do Ceará — Fortaleza,
  • Fundacao do ABC Faculdade de Medicina do ABC — São Paulo,
  • Infirmière recherche Clinique, IUCPQ — Québec, Quebec
  • Anhui Provincial Hospital — Hefei, Anhui
  • Beijing Chao Yang Hospital — Beijing, Beijing Municipality
  • Peking Union Medical College Hospital — Beijing, Beijing Municipality
  • Peking University Cancer Hospital — Beijing, Beijing Municipality
  • Beijing Chest Hospital,Capital Medical University — Beijing, Beijing Municipality
  • Fujian Provincial Cancer Hospital — Fuzhou, Fujian
  • Guangdong General Hospital — Guangzhou, Guangdong
  • Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei
  • Hunan Cancer Hospital — Changsha, Hu'nan
  • Union Hospital of Tongji Medical College of Huazhong Science and Techology University — Wuhan, Hubei
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology — Wuhan, Hubei

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗