224 Participants Needed

Taletrectinib for Non-Small Cell Lung Cancer

(TRUST-II Trial)

Recruiting at 80 trial locations
AC
LL
Overseen ByLian Li
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically those that are potent inhibitors or inducers of CYP3A4/5 or P-glycoprotein, and those that can prolong the QT interval, at least 14 days before starting the study treatment and while on treatment.

What makes the drug Taletrectinib unique for treating non-small cell lung cancer?

Taletrectinib is unique because it targets specific genetic mutations in non-small cell lung cancer, potentially offering a new option for patients who do not respond well to existing treatments like BRAF inhibitors, which are limited to certain mutations.12345

Research Team

LL

Lian Li

Principal Investigator

AnHeart Therapeutics Inc.

Eligibility Criteria

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.

Inclusion Criteria

Life expectancy ≥12 weeks
My cancer is confirmed to be advanced or has spread, through testing.
Compliance with study scheduled visits, treatment plans, and procedures
See 9 more

Exclusion Criteria

Presence of severe medical or mental diseases in which risk is increased by study participation
I haven't taken certain medications in the last 14 days.
I am taking medication that can affect my heart's rhythm.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive taletrectinib monotherapy in 21-day cycles, with some receiving combination therapy with carboplatin and pemetrexed for 4 cycles

Until disease progression
Regular visits for tumor response evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including long-term survival follow-up

Up to 4 years

Treatment Details

Interventions

  • Taletrectinib
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TaletrectinibExperimental Treatment1 Intervention
Single-arm trial whereby all consented, enrolled, eligible patients receive taletrectinib

Taletrectinib is already approved in China for the following indications:

🇨🇳
Approved in China as DOVBLERON for:
  • ROS1-positive non-small cell lung cancer (NSCLC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nuvation Bio Inc.

Lead Sponsor

Trials
12
Recruited
1,200+

AnHeart Therapeutics Inc.

Industry Sponsor

Trials
13
Recruited
1,900+

Findings from Research

In a phase 2 study with a minimum of 5-year follow-up, the combination of dabrafenib and trametinib showed a high overall response rate of 68.4% in pretreated patients and 63.9% in treatment-naive patients with BRAF V600E-mutant metastatic NSCLC, indicating strong efficacy.
The therapy demonstrated a manageable safety profile, with pyrexia being the most common side effect (56%), and provided substantial overall survival benefits, with median overall survival of 18.2 months for pretreated patients and 17.3 months for treatment-naive patients.
Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis.Planchard, D., Besse, B., Groen, HJM., et al.[2022]
In a review of 10 studies involving 18 patients with BRAF non-V600E mutant lung cancer, targeted therapies like trametinib showed a potential clinical benefit rate of 34%, indicating some efficacy in this patient group.
There is currently no standard treatment for BRAF non-V600E mutations, as responses to therapies like vermurafenib and dabrafenib vary significantly, highlighting the need for more extensive research to establish effective treatment protocols.
[Strategic Exploration of Targeted Therapy for BRAF Non-V600E Mutant Lung Cancer].Zhang, H., Gao, J., Guo, W., et al.[2022]
In a retrospective study of 35 patients with advanced BRAF-mutant lung adenocarcinoma treated with BRAF inhibitors, the overall response rate was 53%, and the disease control rate was 85%, indicating significant efficacy of these targeted therapies.
Patients with the V600E mutation had a median overall survival of 25.3 months with first-line therapy, compared to 11.8 months for those with other BRAF mutations, highlighting the importance of mutation type in treatment outcomes.
Targeted Therapy for Patients with BRAF-Mutant Lung Cancer: Results from the European EURAF Cohort.Gautschi, O., Milia, J., Cabarrou, B., et al.[2022]

References

Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. [2022]
[Strategic Exploration of Targeted Therapy for BRAF Non-V600E Mutant Lung Cancer]. [2022]
Targeted Therapy for Patients with BRAF-Mutant Lung Cancer: Results from the European EURAF Cohort. [2022]
SAFFRON-103: a phase 1b study of the safety and efficacy of sitravatinib combined with tislelizumab in patients with locally advanced or metastatic non-small cell lung cancer. [2023]
Lung Cancer Driven by BRAFG469V Mutation Is Targetable by EGFR Kinase Inhibitors. [2022]