What is the mechanism of action of this treatment?

Tyrosine Kinase Inhibitors (TKIs) like Taletrectinib target specific genetic mutations such as ROS1 and NTRK gene fusions in Non-Small Cell Lung Cancer (NSCLC). These inhibitors block the activity of tyrosine kinases, enzymes that play a crucial role in cell division and survival. By inhibiting these enzymes, TKIs can stop the growth and spread of cancer cells. This targeted approach is significant for NSCLC patients as it offers more personalized and effective treatment options, often leading to better outcomes and fewer side effects compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for NSCLC, particularly Tyrosine Kinase Inhibitors (TKIs) like Taletrectinib, often have side effects including fatigue, nausea, increased liver function tests, and anemia. Specific TKIs such as gefitinib and erlotinib are associated with a significant risk of interstitial lung disease. Other adverse events can include tumor-related bleeding, especially in patients with squamous cell histology or centrally located tumors, and a higher incidence of treatment-related adverse events leading to discontinuation. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Several Tyrosine Kinase Inhibitors (TKIs) have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC) targeting specific genetic mutations. For ROS1-positive NSCLC, crizotinib and lorlatinib have been approved. For NTRK gene fusion-positive cancers, including NSCLC, larotrectinib and entrectinib have been approved. These targeted therapies have shown efficacy in treating advanced or metastatic NSCLC with specific genetic alterations, similar to the investigational drug Taletrectinib.

What other types of research exist?

Promising alternatives to Taletrectinib for NSCLC patients include Entrectinib and Larotrectinib for NTRK fusion-positive tumors, and Dabrafenib plus Trametinib for BRAF V600E mutations. For HER2 mutations, Pyrotinib and Poziotinib are potential options. These therapies have shown efficacy in clinical trials and are approved for use in specific genetic contexts.

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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

Must not have

Gastrointestinal disorders affecting absorption of oral medications

History or evidence of specific pulmonary conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing taletrectinib, a new drug, in patients with advanced lung cancer that have a specific genetic change. Taletrectinib is taken orally and aims to stop cancer growth by blocking this genetic change.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a stomach or intestine problem that affects how I absorb pills.

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I have a history of lung conditions.

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I have not had major surgery or a significant injury in the last 4 weeks.

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I have no lasting side effects from previous treatments.

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I do not have any serious infections right now.

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I have untreated spinal cord compression or cancer in the lining of my brain.

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I have not had radiotherapy in the last 14 days.

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I have heart rhythm problems or abnormal EKG results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR) by independent radiology review committee (IRC)

Secondary study objectives

Objective response rate (ORR) assessed by investigators

Pharmacokinetic (PK) profile of taletrectinib

Progression-free survival (PFS)

+1 more

Other study objectives

Intracranial objective response rate (IC-ORR)

Intracranial progression-free survival (IC-PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TaletrectinibExperimental Treatment1 Intervention

Single-arm trial whereby all consented, enrolled, eligible patients receive taletrectinib

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Tyrosine Kinase Inhibitors (TKIs) like Taletrectinib target specific genetic mutations such as ROS1 and NTRK gene fusions in Non-Small Cell Lung Cancer (NSCLC). These inhibitors block the activity of tyrosine kinases, enzymes that play a crucial role in cell division and survival. By inhibiting these enzymes, TKIs can stop the growth and spread of cancer cells. This targeted approach is significant for NSCLC patients as it offers more personalized and effective treatment options, often leading to better outcomes and fewer side effects compared to traditional chemotherapy.