Expanded Access to Ensartinib for Patients with ALK+ Non-Small Cell Lung Cancer

Inclusion Criteria

• Adults over 18 with advanced ALK-positive NSCLC confirmed by an FDA-approved test.
• Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must provide informed consent to participate.
• Not eligible for or unable to access other ongoing ensartinib clinical trials.
• Able to swallow and retain oral medication.
• Agree to use two forms of effective birth control during treatment and for 90 days after the last dose.
• Have adequate organ function.
• Patients with treated brain metastases can join if they have no symptoms and do not need increasing doses of steroids. Patients with untreated brain lesions may also join if they have no symptoms and do not need steroids or seizure medications.

Exclusion Criteria

• Currently receiving cancer treatment.
• Have used an investigational or targeted drug recently, with specific timeframes for different drugs.
• Had major surgery or immunotherapy recently, with specific timeframes for different treatments.
• Allergic to ensartinib or similar drugs, or to tartrazine, a dye in the medication.
• Taking certain medications that interact with ensartinib.
• Have active digestive issues that affect how the body processes the drug.
• Have significant heart disease.
• Have a weakened immune system, serious infection, or certain viral infections like hepatitis C or HIV.
• Have psychological or other conditions that prevent following the study protocol.
• Have lung diseases like interstitial lung disease or pneumonitis.
• Pregnant or breastfeeding women.
• Any other condition or medication that poses a risk or makes participation inappropriate.