TRUST-II Study
TRUST-II study is a global multicenter Phase 2 study to assess the efficacy and safety of the taletrectinib in participants with advanced or metastatic ROS1 positive NSCLC and other cancers.
The study has started and is actively recruiting participants since September 2021.
The study is ongoing in more than nine countries in Asia, Europe and North America including China, Japan, Korea, France, Italy, Poland, Spain, Canada, and United States.
Depending on the tumor type and previous treatment, participants will be enrolled into this study and be divided into 4 groups (cohorts).
Key eligibility criteria for TRUST-II
Key Inclusion Criteria
- Age ≥18 years (or ≥20 years as required by local regulations).
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC (cohorts 1-3) or other solid tumors (cohort 4).
- Evidence of ROS1 fusion in tumor tissue determined by a validated assay as performed in CLIA-certified or locally equivalent diagnostic laboratories.
- Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously treated and controlled, are allowed.
- The patient is either ROS1 TKI treatment naïve, or treated with prior ROS1 TKI(s)
- ECOG Performance Status: 0 or 1.
- Patients with adequate organ function (Bone Marrow, Hepatic, Renal)
Exclusion Criteria
- Treatment with other investigational agents or anticancer therapy within 2 weeks
- Previously treated with IO including immune checkpoint inhibitors within 12 weeks before enrollment.
- Major surgery within 4 weeks prior to enrollment.
- Radiation therapy with a limited field for palliation within 1 week before study treatment
- AEs due to prior therapy are unresolved to ≤ CTCAE Grade 1 except for AEs not constituting a safety risk to the patient in the judgment of investigators.
- Active and clinically significant bacterial, fungal, or viral infection including HBV, HCV, or SARS-CoV-2, known HIV and AIDS-related illness.
Study site list in the US
Please refer to the study sites indicated in the map.
California
RecruitingBeverly Hills Cancer Center
Beverly Hills, California, 90211
RecruitingMoores Cancer Center at UC San Diego
La Jolla, California, 92037
RecruitingKeck Medicine of University of Southern California
Los Angeles, California, 90089
RecruitingUCI Medical Center
Orange, California, 92868
RecruitingPMK Medical Group Inc
Oxnard, California, 93030
RecruitingAmerican Institute of Research
Whittier, California, 90601
Florida
RecruitingSCRI - Florida Cancer Specialists South
Fort Myers, Florida, 33901
RecruitingMemorial Healthcare System
Hollywood, Florida, 33021
RecruitingCancer Specialists of North Florida
Jacksonville, Florida, 92868
Louisiana
RecruitingSCRI - Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809
Minnesota
RecruitingMayo Clinic
Rochester, Minnesota, 55902
New Jersey
Active, not recruitingCenter for Cancer Research
Brick, New Jersey, 08724
Ohio
RecruitingCleveland Clinic Foundation
Cleveland, Ohio, 44195
Tennessee
RecruitingSCRI - Tennessee Oncology
Nashville, Tennessee, 37203
Texas
RecruitingRenovatio Clinical
Dallas, Texas, 75001
RecruitingTexas Oncology, P.A.
Dallas, Texas, 75246
RecruitingRenovatio Clinical - The Woodlands
Houston, Texas, 77056
Washington
RecruitingNorthwest Medical Specialties PLLC
Tacoma Washington, 98405
ROS1 Positive Non- Small Cell Lung Cancer
Lung cancer is a type of cancer that begins in the cells of lung. Lung cancer is the leading cause of cancer death worldwide.
There are two types of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). About 80% to 85% of lung cancers are NSCLC.
Most lung cancers do not cause any symptoms until they have spread, but some people with early lung cancer do have symptoms.
What is taletrectinib?
Taletrectinib belongs to the small molecule targeted therapy. Targeted therapy is a type of cancer treatment that targets proteins that control how cancer cells grow, divide, and spread. It is the foundation of precision medicine. Small molecules are small enough to enter cells easily, so they are used for targets that are inside cells.
Taletrectinib is an investigational potent, selective, brain penetrant, next-generation, ROS1 tyrosine kinase inhibitor (TKI). The results from both non-clinical and clinical studies showed that taletrectinib could stop the function of certain proteins that may help cancer grow in participants, with or without crizotinib prior treatment. And it has showed clinical effects in ROS1 positive NSCLC participants with brain metastasis.
