TRIDENT-1 is enrolling participants in a Phase 2 multi-center study evaluating an investigational drug repotrectinib for the treatment of individuals with ROS1+ advanced non-small cell lung cancer (NSCLC) as well as individuals with NTRK+ advanced solid tumors.
WHAT DOES IT MEAN TO BE ROS1+ or NTRK+?
All cancers begin when one or more genes change/rearrange and the cell starts to divide and grow out of control. Identifying these abnormal genes is important, because drugs can be developed to target and stop them.
A ROS1 rearrangement is an abnormality in a gene that can occur in cancer cells such as in lung cancer cells. NTRK+ gene abnormalities can occur in various solid tumor cancers.
TRIDENT-1 is a clinical study that is evaluating whether repotrectinib is effective in ROS1+ advanced non-small cell lung cancer and TRK+ (i.e. NTRK1-3) advanced solid tumors.
About the Investigational Drug
Tyrosine Kinase Inhibitors (TKIs) like the investigational drug repotrectinib are targeted therapies that attack cancer cells.
Cancer cells often develop mutations (changes in the genetic material of a cell) that prevent entry for TKIs to hit their target. Repotrectinib was designed to inhibit (block) rearranged forms of ROS1 and TRK and was also designed to be small enough to potentially bypass the barriers caused by two common types of mutations: 1) solvent front and 2) gatekeeper. The TRIDENT-1 study is evaluating repotrectinib in individuals with non-small cell lung cancer who have tested positive for ROS1, and in individuals with advanced solid tumor cancers that have tested positive for TRK.
Repotrectinib comes in pill form and is taken by mouth.
What Does Taking Part in the TRIDENT-1 Clinical Study Involve?
SCREENING:
In order to participate you will need to be evaluated to determine if you are eligible to participate. It may take up to 28-days to evaluate whether you are eligible for the study.
DOSING PERIOD:
If you are eligible to participate, you will take the investigational drug daily for 28 days in each cycle (28-day cycles* = approximately one month)
*There is no maximum duration for this study. You can continue with your cycles of study treatment until any of the following occur: your disease worsens, you decide to no longer participate in the study, the study doctor decides you should no longer participate in the study, the study sponsor decides to stop the study.
FOLLOW UP PERIOD:
Once you stop taking the investigational drug, we would like to perform a follow-up visit to see how you are doing. The follow-up visit will occur 28 days after your last dose of investigational drug, and then a check-in via phone every 3 months.
HOW COULD I PARTICIPATE IN THE STUDY?
You may be eligible to participate if you are at least 12 years old and have locally advanced or metastatic solid tumors.
Clinical Study eligibility requirements will apply, and only a qualified healthcare professional can determine if you or a loved one are eligible to participate in the study.
STUDY SITE LOCATIONS
Find a participating U.S. site location near you and take the following questionnaire that may help to determine if you are eligible.
Clinical Study eligibility requirements will apply, and only a qualified healthcare professional can determine if you or a loved one are eligible to participate in the study.
How Can I Learn More About TRIDENT-1?
If you are located in Hungary and interested in learning more about the TRIDENT-1 clinical study, please complete the following questionnaire and a study representative will contact you within 2-3 business days. You can also contact us directly at (xxx) xxx-xxxx (M-F from X am to X pm).
This study was approved in Hungary by the National Institute of Pharmacy and Food Health on the basis of the expert opinion of the Clinical Pharmacology Ethics Committee of the Health Science Council.
* Indicates Required Field
Frequently Asked Questions
What is a clinical study?
A clinical trial is a research study aimed at evaluating whether a study preparation is safe and effective in humans. Participants will receive special test treatments and the researchers will closely monitor the results to determine if the product can be approved for wider use. Regulatory authorities apply strict rules to conduct clinical trials and require the investigational product to be safe and effective before it can be widely used.
What is an investigational drug?
An investigational drug is a drug that has not been approved by regulatory authorities but can be administered to people in a clinical study for research purposes.
What type of clinical study is TRIDENT-1?
TRIDENT-1 is a phase 1/2 clinical study evaluating an investigational drug repotrectinib for the treatment of participants with ROS1+ advanced non-small cell lung cancer (NSCLC) as well as participants with NTRK+ advanced solid tumors. There is no cost to participants to be in the study and there is no maximum duration for this study. You can continue with your cycles of study treatment until any of the following occur: your disease worsens, you decide to no longer participate in the study, the study doctor decides you should no longer participate in the study, the study sponsor decides to stop the study.
How can I learn more about the investigational medication and this study?
More information on this clinical study can be found on clinicaltrials.gov (Protocol number TPX-0005-01) or Turning Point Therapeutics Website.
Study Site Locations
Current U.S. study locations are listed below, and more may be added as they open. If you are interested in participating in the TRIDENT-1 study, complete the form to speak with a study representative who can also provide available study locations.
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