A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors (TRUST-II)

  • STATUS
    Recruiting
  • End date
    Jun 21, 2027
  • participants needed
    119
  • sponsor
    AnHeart Therapeutics Inc.
Updated on 21 October 2022
ROS1
proto-oncogene tyrosine-protein kinase ros
Accepts healthy volunteers

Summary

The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.

Description

This is a global Phase 2, multicenter, single-arm, open label study of taletrectinib in patients of NSCLC harboring with ROS1 fusion gene.

119 patients will be enrolled and divided into 4 cohorts, depending on past history of ROS1 TKI treatment.

Taletrectinib will be administered 600mg once daily in 21-day cycles. Patients will continue with the study treatment until progression of disease as determined by the investigator.

The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.

Details
Condition Non Small Cell Lung Cancer
Treatment Taletrectinib
Clinical Study IdentifierNCT04919811
SponsorAnHeart Therapeutics Inc.
Last Modified on21 October 2022

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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