ROS1 positive advanced or metastatic non-small cell lung cancer (NSCLC) and Other Solid Tumors
Conditions
Interventions
taletrectinib 600 mg orally administered once daily every day. Dose reduction by 1st level, or if needed by 2nd level, will be allowed depending on the type and severity of toxicity encountered.
Sponsors
ONO Chihiro Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient age 18 years and over (or 20 years and over as required by local regulations). 2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC (cohorts 1-3) or other solid tumors (cohort 4). 3. Evidence of ROS1 fusion in tumor tissue determined by molecular assays as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified or locally equivalent laboratories. Sufficient tumor tissue is required for performing confirmatory ROS1 fusion testing at the designated central laboratories. 4. Patients in cohort 1 must have an archival tumor tissue specimen available and collected prior to enrollment. If archival tumor tissue is unavailable, then a mandatory fresh biopsy must be performed. For patients in cohort 2, a mandatory fresh biopsy is required before enrollment even if archival tumor tissue is available. For cohorts 3-4, either an archival tumor tissue or a fresh tumor sample must be available before enrollment. 5. Patients with central nervous system (CNS) involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed; the use of seizure prophylaxis is allowed as long as patients are taking non enzyme-inducing anti-epileptic drugs (non-EIAEDs). If corticosteroid treatment is required, it should be on stable or decreasing dose of 10 mg prednisone equivalent or less. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment at least 14 days before enrollment and be clinically stable. 6. The patient is either ROS1 TKI treatment naive, or treated with prior ROS1 TKI(s): Cohort 1: Systemic chemotherapy naive or pretreated with one prior line of chemotherapy, but never treated with any ROS1 TKI Cohort 2: Pretreated with one prior ROS1 TKI which is locally marketed, AND pretreated with =2 prior ROS1 TKIs, AND pretreated with =1,500 per microliter d) Platelet count: >=100,000 per microliter e) Hemoglobin: >=9.0 g per deciliter f) Serum creatinine: <=1.5 x ULN. 11. Males and/or females who meet any of the following criteria: a) For males (irrespective of surgical sterilization [vasectomy]): agree to use effective contraception methods during the study intervention period and for at least 90 days after the last dose of investigational drug or agree with complete abstinence; b) For females be post-menopausal for at least one year prior to screening or be documented surgically sterilized. Women of childbearing potential (WOCBP) must agree to use two concurrent effective methods of contraception or agree with complete abstinence from sexual intercourse since the informed consent until 90 days after the
Exclusion criteria
Exclusion criteria: 1. Investigational agent or anticancer therapy within 2 weeks (or 5 half-lives of the compound, whichever is longer) prior to study enrollment. In addition, no concurrent anticancer therapy is permitted. 2. Previously treated with immuno-oncology (IO) including immune checkpoint inhibitors within 12 weeks before enrollment. 3. Major surgery within 4 weeks prior to enrollment. 4. Radiation therapy with a limited field for palliation within 1 week of the first dose of study treatment. 5. Toxicities due to prior therapy are unresolved to CTCAE 5.0 Grade 2, uncontrolled atrial fibrillation of any grade, or QT interval corrected for heart rate (QTc) interval >470 milliseconds (female) or QTc interval >450 milliseconds (male), or symptomatic bradycardia <45 beats per minute. 12. Pregnancy or lactation. 13. Use of food or drugs that are known potent cytochrome P450 3A4/5 (CYP3A4/5) inhibitors or inducers or P-glycoprotein inhibitors or inducers within 14 days prior to the first dose of study treatment. 14. Patients with other severe medical or mental diseases in whom the risk is increased by the participation to the study or treatment with investigational drug in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of taletrectinib by the objective response rate (ORR) | — |
Countries
Canada, France, Italy, Japan, korea, Spain, United States
Contacts
Public ContactMegumi Yamamoto
CMIC Co., Ltd.
Outcome results
None listed