Lung NeoplasmsTale EAPNCT06841874
Expanded Access Program of Taletrectinib in Patients With Advanced or Metastatic ROS1-Positive NSCLC
A study testing Taletrectinib in people with Lung Neoplasms and Respiratory Tract Neoplasms, run by Nuvation Bio Inc..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms
- What is being tested?
- Taletrectinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases
- Being tested
- Taletrectinib
- Keywords
- Non-Small Cell Lung Cancer (NSCLC), ROS1-Positive Non-Small Cell Lung Cancer
- Medical subject headings
- Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaletrectinibDrug
Also called AB-106
Oral capsule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Nuvation Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841874
- Sponsor's protocol ID
- AB-106-EAP
- Acronym
- Tale EAP
- Status last verified
- Dec 2025
- First submitted
- 11 Feb 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program of Taletrectinib in Patients With Advanced or Metastatic ROS1-Positive NSCLC
- ClinicalTrials.gov ID
- NCT06841874
- Acronym / sponsor ID
- Tale EAP / AB-106-EAP
- Conditions
- Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases
- Keywords
- Non-Small Cell Lung Cancer (NSCLC), ROS1-Positive Non-Small Cell Lung Cancer
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Nuvation Bio Inc.Industry (pharma, biotech, devices)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaletrectinibAlso: AB-106Oral capsule | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Taletrectinib in people with Lung Neoplasms and Respiratory Tract Neoplasms, run by Nuvation Bio Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.