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.