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Tyrosine Kinase Inhibitor

Taletrectinib for Non-Small Cell Lung Cancer (TRUST-II Trial)

Phase 2
Recruiting
Research Sponsored by AnHeart Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC or other solid tumors
Patients with stable CNS involvement, including leptomeningeal carcinomatosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

TRUST-II Trial Summary

This trial is studying taletrectinib to see how well it works in treating patients with non-small cell lung cancer.

Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) that tests positive for ROS1 fusion can join this trial. They should have at least one measurable tumor, be able to follow the study plan and COVID-19 rules, and not be pregnant or breastfeeding. People who've had certain recent treatments or have serious health issues like heart disease, untreated brain metastases, active infections, or a history of significant lung problems are excluded.Check my eligibility
What is being tested?
The trial is testing Taletrectinib's safety and effectiveness as a solo treatment for NSCLC. It includes patients who may or may not have used similar drugs before. The focus is on those whose cancer has spread beyond the original site and involves assessing how well they respond to this medication.See study design
What are the potential side effects?
Taletrectinib could cause side effects such as liver issues, fatigue, nausea, constipation, coughing and difficulty breathing due to potential lung problems (like pneumonitis), changes in heartbeat rhythm or speed (cardiac dysrhythmias), and possible interactions with other medications.

TRUST-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed to be advanced or has spread, through testing.
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My brain or spinal cord cancer is not getting worse.
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I am fully active or can carry out light work.
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My cancer has a ROS1 fusion.
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My liver, blood, and kidney functions are within normal ranges.
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I am at least 18 years old, or 20 if required by local laws.

TRUST-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR) by independent radiology review committee (IRC)
Secondary outcome measures
Objective response rate (ORR) assessed by investigators
Pharmacokinetic (PK) profile of taletrectinib
Progression-free survival (PFS)
+1 more
Other outcome measures
Intracranial objective response rate (IC-ORR)
Intracranial progression-free survival (IC-PFS)

TRUST-II Trial Design

1Treatment groups
Experimental Treatment
Group I: TaletrectinibExperimental Treatment1 Intervention
Single-arm trial whereby all consented, enrolled, eligible patients receive taletrectinib

Find a Location

Who is running the clinical trial?

AnHeart Therapeutics Inc.Lead Sponsor
10 Previous Clinical Trials
584 Total Patients Enrolled
Lian LiStudy DirectorAnHeart Therapeutics Inc.
Study DirectorStudy DirectorAnHeart Therapeutics Inc.
1,203 Previous Clinical Trials
489,355 Total Patients Enrolled

Media Library

Non-Small Cell Lung Cancer Research Study Groups: Taletrectinib
Non-Small Cell Lung Cancer Clinical Trial 2023: Taletrectinib Highlights & Side Effects. Trial Name: NCT04919811 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for new participants in this trial?

"Absolutely. Evidence from clinicaltrials.gov confirms that this research, which was first published on September 1st 2021, is still recruiting subjects. A total of 119 participants are needed across 25 distinct medical sites."

Answered by AI

What is the scope of enrolment for this research project?

"AnHeart Therapeutics Inc. need to enlist 119 participants that meet their study's criteria, and are running the trial from multiple sites such as Keck Medicine of University of Southern California in LA and Moores Cancer Center at UC San Diego in La Jolla, Minnesota."

Answered by AI

What deleterious effects have been observed when taking Taletrectinib?

"We at Power assign a safety rating of 2 to taletrectinib, as there is some evidence backing its safe use but none that speaks to efficacy."

Answered by AI

How many healthcare settings are participating in this trial?

"This trial has 25 active clinical sites including Keck Medicine of University of Southern California in Los Angeles, Moores Cancer Center at UC San Diego in La Jolla and Mayo Clinic in Rochester. Additionally, there are 22 other operating centres."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
American Institute of Research
What portion of applicants met pre-screening criteria?
Met criteria
~70 spots leftby Jun 2025