Clinical Trials for ROS1+ Cancer
You can find clinical trials for ROS1+ cancer anywhere in the world by searching the clinicaltrials.gov website (or clinicaltrialsregister.eu for trials in Europe). All clinical trials conducted in the USA are required to be listed on this site, and most trials conducted by major drug companies in other countries are also listed. However, not every trial in every country is listed. Various clinical trial finder apps exist to make searching this database easier, but they are all searching the same database.
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There are a few dozen clinical trials for ROS1+ cancers running in the world today. Some trials are for novel ROS1 targeted therapies; others are for chemotherapy, radiation therapy, adjuvant TKIs, or combination therapies.
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Because the status and sites for each trial can change frequently, The ROS1ders doesn't have the staff to keep a complete list of trials updated online. However, we do communicate with pharmaceutical firms that have experimental or approved ROS1 TKIs and have current information on several of the experimental treatments listed below. This list was last updated on 19-February-2022.
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Some clinical trials might assist with travel planning and expense. If this your patient is interested in this, have them contact the trial site where they would like to participate. The ROS1ders do not have funding available for treatment, but we may be able to assist in connecting the patient to resources (contact us).
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TKI | Sponsor | Trial Phase | Clinical Trial | Sites | Treats Brain | Trial Features |
|---|---|---|---|---|---|---|
entrectinib | ASCO | 2 | Over 250 in 28 states within the USA | yes | Advanced ROS1+ solid tumors (not NSCLC); no previous ROS1 TKI; does not require fresh biopsy | |
taletrectinib
(DS-6051b,
AB-106) | Anheart Therapeutics | 2 | International
(opened fall 2021) | yes | Targets resistance mutations G2032R, L2026M, L1951R, and S1986F; Avoids TRKB-related CNS adverse events | |
zidesamtinib (NVL-520) | Nuvalent | 1 | International
(opened fall 2021) | yes | Avoids TRK-related CNS adverse events; targets resistance mutations G2032R, S1986Y/F, L2026M, D2033N | |
lorlatinib, binimetinib, TNO155 | Array BioPharma, Pfizer | 1 | Boston, MA, USA | yes | Requires disease progression or intolerance to at least 1 TKI, pretreatment biopsy, plus serial biopsies | |
lorlatinib | IFCT | 2 | France | yes | Progression after one line of crizotinib or entrectinib; requires fresh biopsy | |
TQ-B3101 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 2 | China | unknown | has no CNS metastases; no previous TKI or immunotherapy (0-2 regimens of chemotherapy allowed) | |
crizotinib and entrectinib | Hoffmann-La Roche | 3 | China, Italy, Netherlands, Spain | no, yes | Compares outcomes of the two drugs; no prior treatment with ROS1 TKI, chemotherapy or other systemic therapy | |
entrectinib | Hoffmann-La Roche | 2 | International | yes | ROS1+ locally advanced or metastatic solid tumor; requires archival or fresh tumor tissue for testing | |
repotrectinib and crizotinib | BMS | 3 | International (opened fall 2023) | yes/no | radomized comparison of repotrectinib and crizotinib in ROS1+ NSCLC |
ROS1 TKIs in Clinical Trials
Drug names are linked to the reference section that lists scientific presentations and journal articles about the drug.
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Talectrectinib An experimental TKI; most recent data is phase 2 trial interim data (Li W et al, Abstract 8572 at ASCO 2022)
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NVL-520 An experimental TKI; most recent data is preclinical (Pelish H, Abstract 1465 in AACR Annual Meeting, 2021. DOI: 10.1158/1538-7445.AM2021-1465)
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Lorlatinib Phase 2 trials are available in some countries. According to Pfizer representatives, this drug is not available via Compassionate Use to new ROS1+ cancer patients who are not already taking the drug. However, some ROS1ders outside of the USA report being able to access it.
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TQ-B3101 is a tyrosine kinase inhibitor being developed in China. Preliminary results of the single arm Phase II trial are similar to crizotinib.
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Binimetinib is a MEK1 and MEK2 tyrosine kinase inhibitor approved for use in combination therapy for BRAF V600E mutant melanoma .
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TNO155 is a pyrazine class of allosteric SHP2 inhibitor.
Several of the TKIs approved for non-small cell lung cancer are available for ROS1+ solid tumors via basket clinical trials or expanded access.
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Some drug trials for ROS1 might not be listed on clinicaltrials.org, or might not share information about the drug publicly. The ROS1ders won't have knowledge of those trials or drugs.
Medically reviewed by ROS1 Clinician-Researchers
Last updated 05-Feb-2024