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

🧪 Interventions in This Study

• X-396 (ensartinib) (DRUG)
• crizotinib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive by an FDA-approved assay performed centrally. Patients must be ALK positive by local test prior to submitting tissue to the central lab. Randomization will occur after ALK positive confirmation is received from the central lab. Patients may have received up to 1 prior chemotherapy regimen for metastatic disease, which may also include maintenance therapy. Note that patients that have received adjuvant or neoadjuvant chemotherapy and developed metastatic disease within 6 months from the end of that therapy would be considered to have received 1 prior regimen for metastatic disease.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2. (see Appendix A)
3. Life expectancy of at least 12 weeks.
4. Ability to swallow and retain oral medication.
5. Adequate organ system function, defined as follows:
6. Absolute neutrophil count (ANC) ≥1.5 x 109/L
7. Platelets ≥100 x 109/L
8. Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level
9. Total bilirubin ≤1.5 times the upper limit of normal (ULN)
10. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.
11. Creatinine \< 1.5 x ULN. If \>1.5 x ULN, patient may still be eligible if calculated creatinine clearance \>50 mL/min (0.83mL/s) as calculated by the Cockcroft-Gault method.
12. Brain metastases allowed if asymptomatic at study baseline. Patients with untreated brain metastases must not be on corticosteroids. If patients have neurological symptoms or signs due to CNS metastases, patients need to complete whole brain radiation or focal treatment at least 14 days before start of study treatment and be asymptomatic on stable or decreasing doses of corticosteroids at baseline.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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.

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💡 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.