TRUST-II: a global phase II study of taletrectinib in ROS1 -positive non-small-cell lung cancer and other solid tumors
Open accessAbstract
Crizotinib and entrectinib have been approved to treat ROS1 fusion-positive (ROS1+) non-small-cell lung cancer. However, unmet needs remain, including treatment of patients with resistance mutations, efficacy in brain metastasis and avoidance of neurological side effects. Taletrectinib was designed to: improve efficacy; overcome resistance to first-generation ROS1 inhibitors; and address brain metastasis while conferring fewer neurological adverse events. All of these features are demonstrated and supported by the interim data from the regional phase II TRUST-I clinical study. Here we describe the rationale and design of TRUST-II, a global phase II study of taletrectinib in patients with locally advanced/metastatic ROS1+ non-small-cell lung cancer and other ROS1+ solid tumors. The primary end point is confirmed objective response rate. Secondary end points include duration of response, progression-free survival, overall survival and safety. This trial is enrolling patients in North America, Europe and Asia.
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The integrated analysis is feasible because both studies had similar pivotal study designs, inclusion and exclusion criteria, primary and secondary end points, identical efficacy and safety assessment methods and schedules, and consistent statistical approaches.
“This integrated analysis is feasible because both studies had similar pivotal study designs, inclusion and exclusion criteria, and primary and secondary end points. In addition, the efficacy and safety assessment methods and their schedules were identical, and statistical approaches were consistent between these studies.19,20”
From Taletrectinib in <i>ROS1</i> + Non–Small Cell Lung Cancer: TRUST (2025) · cites this paper as [19]
Taletrectinib is an oral, CNS-active, next-generation ROS1 TKI with 11- to 20-fold selectivity over TrKB.
“Taletrectinib is an oral, CNS-active, next-generation ROS1 TKI with 11- to 20-fold selectivity over TrKB, which may translate into lower rates of, less severe, or limited spectrum of neurologic AEs.19,20”
From Taletrectinib in <i>ROS1</i> + Non–Small Cell Lung Cancer: TRUST (2025) · cites this paper as [19]
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Taletrectinib in <i>ROS1</i> + Non–Small Cell Lung Cancer: TRUST
Pérol, M., Li, W., Pennell, N. A., Liu, G., Ohe, Y., De Braud, F., Nagasaka, M., Felip, E., Xiong, A., Zhang, Y., et al. (2025) · Journal of Clinical Oncology · doi:10.1200/jco-25-00275 · Cited by 63 · see citing works
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Self-citationAdvances and future directions in <i>ROS1</i> fusion-positive lung cancer
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- Authors
- Nagasaka, M., Ohe, Y., Zhou, C., Choi, C.-M., Yang, N., Liu, G., Felip, E., Pérol, M., Besse, B., Nieva, J., Raez, L., Pennell, N. A., Dimou, A., Marinis, F. D., Ciardiello, F., Seto, T., Hu, Z., Pan, M., Wang, W., Li, S., & Ou, S.-H. I.
- Affiliations
- University of California, Irvine (US)
- National Cancer Center Hospital (JP)
- Tongji University (CN)
- Asan Medical Center (KR)
- Central South University (CN)
- University Health Network (CA)
- Vall d'Hebron Hospital Universitari (ES)
- Department of Medical Oncology,Léon Bérard Cancer Center, Lyon, France
- Université Paris-Saclay (FR)
- University of Southern California (US)
- Florida Atlantic University (US)
- Cleveland Clinic (US)
- Mayo Clinic (US)
- European Institute of Oncology (IT)
- University of Campania "Luigi Vanvitelli" (IT)
- Precision Medicine Asia (PREMIA) Co. Ltd, Tokyo, Japan
- AnHeart Therapeutics, NY, USA
- Corresponding author
- Nagasaka, Misako
- Ou, Sai-Hong I
- ORCID
- Venue
- Future Oncology
- Publisher
- Informa UK Limited
- Published
- 2023-01
- Volume
- 19
- Issue
- 2
- Pages
- 123-135
- ISSN
- 1479-6694 (ISSN-L)
- 1744-8301
- OpenAlex
- W4323294773
- Cited by
- 32
- References
- 10
- Citations by year
- 2026: 11 · 2025: 10 · 2024: 9 · 2023: 2
- FWCI
- 5.87
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Future Oncology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- Funders
- consulting or advisory role
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- taletrectinib, non-small cell lung cancer, solid tumors, ALK inhibitors, crizotinib resistance, brain metastases, neurological adverse events, objective response rate, progression-free survival, overall survival, drug safety
- MeSH terms
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Humans, Imidazoles, Lung Neoplasms, Protein-Tyrosine Kinases, Proto-Oncogene Proteins, Pyridazines, Clinical Trials, Phase II as Topic, Protein Kinase Inhibitors
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