Last-Resort drug access for rare lung cancer patients
NCT ID NCT06841874
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This program provides taletrectinib, a targeted cancer pill, to adults with advanced or metastatic ROS1-positive non-small cell lung cancer who cannot join a clinical trial or use approved treatments. Patients must have a ROS1 gene fusion and adequate organ function. The goal is to give access when no other options are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- taletrectinib (a targeted cancer drug taken as a capsule)
- What this could lead to
- If it works, this could offer a treatment option for people with a specific type of lung cancer who have run out of standard choices.
- What could go wrong
- This is an expanded access program, not a formal trial, so data on effectiveness and safety are limited. The drug may not work for everyone and could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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