Expanded Access Program of Taletrectinib in Patients With Advanced or Metastatic ROS1-Positive NSCLC (Tale EAP)

December 17, 2025 updated by: Nuvation Bio Inc.
This Expanded Access Program will provide access of taletrectinib therapy to patients with locally advanced or metastatic ROS1-positive NSCLC who are not an appropriate candidate for an approved therapy, for any ongoing taletrectinib clinical trial and who, in the opinion of their oncologist, may benefit from treatment.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

This Expanded Access Program will provide access of taletrectinib therapy to patients with locally advanced or metastatic c-ros-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC). These patients are not an appropriate candidate for an approved therapy, including crizotinib, entrectinib, or repotrectinib, for participating in ongoing Nuvation Bio clinical trial AB-106-G208 and who, in the opinion of their oncologist, may benefit from treatment.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvation Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Estimated)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-106-EAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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