Expanded Access Program of Taletrectinib in Patients with Advanced or Metastatic ROS1-Positive NSCLC

Inclusion Criteria

• Age ≥ 18 years.
• Histologically or cytologically confirmed diagnosis of locally advanced (including inoperable Stage IIIA or IIIB NSCLC) or metastatic NSCLC.
• Evidence of ROS1 gene fusion.
• Adequate bone marrow and organ function
• Ineligible for participation in ongoing Nuvation Bio clinical trial AB-106-G208. Exception may be granted by the Sponsor/Supplier if they have a restriction or hardships that prevent them from participating in a clinical trial.
• Failed approved therapy or are not an appropriate candidate for an approved therapy including crizotinib, entrectinib, or repotrectinib.

Exclusion Criteria

• Prior systemic anticancer therapy washout of 5 half-lives or 2 weeks, whichever is sooner.
• Patients who develop acute medical conditions which require immediate treatment or stabilization (e.g., new diagnosis of pulmonary embolism that requires anti-coagulation; acute and symptomatic spinal cord compression that requires immediate spinal radiotherapy). Note: patients may enroll after starting treatment for these acute conditions and the patients are considered stabilized.
• History or evidence of interstitial fibrosis, interstitial lung disease or drug-induced pneumonitis that did not resolve prior to screening.
• Active and untreated hepatitis B or C. Exception is chronic stable hepatitis B and C with stable liver function at screening.
• Ongoing cardiac dysrhythmias of Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 2, uncontrolled atrial fibrillation of any grade, or QT interval corrected for heart rate by Fridericia's formula >470 milliseconds, or symptomatic bradycardia <45 beats per minute; patient has family or medical history of long QT syndrome.