Lung Cancer Clinical Trial
Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC
Summary
The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.
Full Description
This is a global Phase 2, multicenter, single-arm, open label study of taletrectinib in patients of NSCLC harboring with ROS1 fusion gene.
119 patients will be enrolled and divided into 4 cohorts, depending on past history of ROS1 TKI treatment.
Taletrectinib will be administered 600mg once daily in 21-day cycles. Patients will continue with the study treatment until progression of disease as determined by the investigator.
The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.
Eligibility Criteria
Inclusion Criteria:
Patient age ≥18 years (or ≥20 years as required by local regulations).
Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC or other solid tumors.
Evidence of ROS1 fusion in tumor tissue determined by molecular assays as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified or locally equivalent laboratories.
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 or equivalent. 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.
The patient is either ROS1 TKI treatment naïve, or treated with prior ROS1 TKI(s).
At least one extracranial measurable unirradiated lesion per RECIST 1.1 assessed by investigator.
Eastern Cooperative Oncology Group Performance Status: 0 or 1.
Patient with a life expectancy ≥12 weeks based on the judgement of investigators.
Patients with adequate organ function meeting the following criteria:
Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): ≤3 × upper limit of normal (ULN) (or ≤5 × ULN, in case of liver abnormalities due to liver metastases)
Serum total bilirubin: ≤1.5 × ULN
Absolute neutrophil count: ≥1,500/μL
Platelet count: ≥100,000/μL
Hemoglobin: ≥ 9.0 g/dL
Serum creatinine: ≤1.5 × ULN
Males and/or females who meet any of the following criteria:
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;
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 last dose of investigational drug. Usage of hormonotherapy for contraception should be recorded as well.
The patient is willing and capable to give written informed consent.
For all females of childbearing potential, a negative pregnancy test must be obtained within 7 days of initial administration.
Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Exclusion Criteria:
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.
Previously treated with immuno-oncology (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 of the first dose of study treatment.
Toxicities due to prior therapy are unresolved to ≤ CTCAE 5.0 Grade 1 except for AEs not constituting a safety risk to the patient based on the judgment of investigators.
Patients with spinal cord compression caused by tumor and/or cancerous meningitis.
History or evidence of interstitial fibrosis or interstitial lung disease or pneumonitis.
Any gastrointestinal disorders that may affect absorption of oral medications.
Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
Clinically significant cardiovascular diseases within 3 months prior to the first dose of investigational drug: myocardial infarction, severe/unstable angina, coronary/peripheral endovascular treatment, heart failure or cerebrovascular disorder including transient ischemic attack.
Ongoing cardiac dysrhythmias of ≥ 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.
Pregnancy or lactation.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 21 Locations for this study
Beverly Hills California, 90211, United States
La Jolla California, 92037, United States
Los Angeles California, 90089, United States
Orange California, 92868, United States
Oxnard California, 93030, United States
Whittier California, 90601, United States
Fort Myers Florida, 33901, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 92868, United States
Baton Rouge Louisiana, 70809, United States
Rochester Minnesota, 55902, United States
Brick New Jersey, 08724, United States
Cleveland Ohio, 44195, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75001, United States
Dallas Texas, 75246, United States
Houston Texas, 77056, United States
Toronto Ontario, , Canada
Montréal Quebec, , Canada
Changsha , , China
Wuhan , , China
Grenoble , , France
Lyon , , France
Nantes , , France
Paris , , France
Poitiers , , France
Reims , , France
Rennes , , France
Bari , , Italy
Catania , , Italy
Milano , , Italy
Milano , , Italy
Milano , , Italy
Milano , , Italy
Monserrato , , Italy
Napoli , , Italy
Roma , , Italy
Fukuoka , , Japan
Kashiwa , , Japan
Miyagi , , Japan
Nagoya , , Japan
Osaka , , Japan
Shizuoka , , Japan
Tokyo , , Japan
Tokyo , , Japan
Busan , 612-0, Korea, Republic of
Gyeongsang , 99900, Korea, Republic of
Hwasun , 540-7, Korea, Republic of
Seoul , 05742, Korea, Republic of
Seoul , 130-8, Korea, Republic of
Barcelona , , Spain
Barcelona , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Málaga , , Spain
Sevilla , , Spain
Valencia , , Spain
Valencia , , Spain
How clear is this clinincal trial information?