Taletrectinib for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, taletrectinib, for individuals with non-small cell lung cancer (NSCLC). The goal is to determine if taletrectinib can prevent cancer recurrence after surgery. Participants must have had a specific lung tumor type (ROS1-fusion positive) surgically removed. The study seeks individuals who have fully recovered from surgery and have not undergone extensive other cancer treatments. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial requires that you avoid using certain medications known as strong cytochrome P450 (CYP)3A inducers or inhibitors for at least 14 days before joining. It's best to discuss your current medications with the trial team to see if any need to be adjusted.
Is there any evidence suggesting that taletrectinib is likely to be safe for humans?
Research has shown that taletrectinib is generally safe for people. Studies have found it effective, with most patients tolerating it well. Reports of serious side effects are few, and the treatment rarely causes brain-related issues, meaning severe problems are uncommon. However, individual experiences may vary with any treatment.12345
Why do researchers think this study treatment might be promising?
Taletrectinib is unique because it targets specific genetic mutations in lung cancer, known as ROS1 and NTRK fusions, which are not directly addressed by standard treatments like chemotherapy or immunotherapy. Most common treatments for lung cancer focus on broadly attacking cancer cells or boosting the body's immune response, but Taletrectinib works differently by directly inhibiting these genetic drivers of cancer growth. Researchers are excited about Taletrectinib because it promises a more personalized approach, potentially leading to better outcomes for patients with these specific mutations.
What evidence suggests that taletrectinib might be an effective treatment for non-small cell lung cancer?
Research has shown that taletrectinib, which participants in this trial may receive, works well for treating ROS1-positive non-small cell lung cancer (NSCLC). Studies found that 85% of patients who had not received prior treatment responded to the drug, while 61.7% of those with previous treatments also responded. The drug helps delay cancer progression. Taletrectinib is usually well-tolerated, meaning it does not cause serious side effects for most people. These findings suggest that taletrectinib could be a promising option to help prevent lung cancer recurrence after surgery.13456
Are You a Good Fit for This Trial?
This trial is for people with early-stage non-small cell lung cancer (NSCLC) that tests positive for ROS1-fusion. They must have had their lung tumor removed and are now looking to prevent the disease from returning. Specific stages eligible include IB, II, IIIA.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive taletrectinib or placebo to assess its efficacy in preventing disease recurrence after tumor resection
Follow-up
Participants are monitored for disease-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Taletrectinib
Trial Overview
The study is testing taletrectinib, a new drug, against a placebo (a sugar pill). Participants will be randomly assigned to receive either the study drug or placebo in order to determine if taletrectinib can better prevent cancer recurrence after surgery.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Active Arm
Placebo Arm
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nuvation Bio Inc.
Lead Sponsor
Citations
Taletrectinib in ROS1+ Non–Small Cell Lung Cancer: TRUST
Taletrectinib showed a high response rate with durable responses, robust IC activity, prolonged PFS, favorable safety, and low rates of neurologic adverse ...
2.
investors.nuvationbio.com
investors.nuvationbio.com/news/news-details/2025/Nuvation-Bio-Announces-New-Data-from-Pivotal-Clinical-Studies-of-IBTROZI-taletrectinib-in-Advanced-ROS1-Positive-Non-Small-Cell-Lung-Cancer-at-2025-World-Conference-on-Lung-Cancer/default.aspxNews Details
Nuvation Bio Announces New Data from Pivotal Clinical Studies of IBTROZI™ (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer ...
3.
targetedonc.com
targetedonc.com/view/taletrectinib-s-sustained-efficacy-in-advanced-ros1-positive-nsclcTaletrectinib's Sustained Efficacy in Advanced ROS1- ...
Taletrectinib demonstrates high efficacy in ROS1-positive NSCLC, with an 85% response rate in treatment-naïve patients and 61.7% in pretreated ...
4.
onclive.com
onclive.com/view/dr-liu-on-updated-efficacy-and-safety-data-with-taletrectinib-in-ros1-nsclcDr Liu on Updated Efficacy and Safety Data With ... - OncLive
Geoffrey Liu, MSc, MD, discusses updated efficacy and safety results with taletrectinib in ROS1-positive non–small cell lung cancer.
1373P Efficacy and safety of taletrectinib in patients (Pts) ...
In this ongoing global pivotal phase 2 study, taletrectinib demonstrated robust and consistent clinical activity with TRUST-I, including high response rates and ...
Taletrectinib in ROS1+ Non-Small Cell Lung Cancer: TRUST
Taletrectinib showed a high response rate with durable responses, robust IC activity, prolonged PFS, favorable safety, and low rates of neurologic adverse ...
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