Safety and Efficacy Study of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
About this trial
This is an interventional treatment trial for ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
Eligibility Criteria
Inclusion Criteria:
1.18 years and older. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;Life expectancy ≥ 3 months.
3.Understood and Signed an informed consent form. 4.Histologically or cytologically confirmed locally advanced or metastatic NSCLC .
5.Subjects in the screening period should provide a written report of ROS1 positive, or tumor histological specimens obtained at the time of diagnosis/post before enrollment are sent to the central laboratory to confirm ROS1 positive.
6. Had received no more than two chemotherapy regimens. 7.At least 1 measurable tumor lesion other than brain lesions within 28 days before first dose based on RECIST 1.1.
8.The main organs function are normally, the following criteria are met:
- routine blood tests(no blood transfusion and blood products within 14 days):hemoglobin(Hb)≥90g/L;absolute neutrophil count(ANC)≥1.5×109/L; platelets(PLT)≥100×109/L.
- Blood biochemical examination: alanine transaminase(ALT)and aspartate aminotransferase(AST)≤2.5×upper limit of normal (ULN)(when the liver is invaded, ALT, and AST ≤5× upper limit of normal (ULN) ); total bilirubin (TBIL)≤1.5×upper limit of normal (ULN);Serum creatinine ≤ 1.5 × upper limit of normal (ULN); or creatinine clearance calculated ≥ 50ml / min (calculated according to Cockcroft-Gault formula);
left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography ≥ 50%.
9.Women must meet one of the following conditions:has undergone surgical sterilization;have been menopausal at least 1 year;have fertility, the following conditions must be met;Serum pregnancy test results were negative; throughout the study period to 6 months after the last dose, agreed to adopt an approved method of contraception (for example: oral contraception, injection contraception or implanted, barrier-effect Contraceptive methods, spermicides and condoms, or intrauterine devices).Men must meet one of the following conditions:has surgical sterilization;an approved method of contraception must be used throughout the study period and 6 months after the last dose.
Exclusion Criteria:
- Has any known endothelial growth factor receptor (EGFR) positive mutation.
- Prior therapy with crizotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or any other ROS1 inhibitor.
- Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.
- Has diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of cured carcinoma in situ of the cervix、 non-melanoma skin cancers and superficial bladder tumors.
- Has a history of hypertensive crisis, hypertensive encephalopathy; or uncontrolled hypertension.
- Has clinically significant, uncontrolled cardio-cerebral vascular disease.
- Has major surgery and anti-tumor treatment before two weeks of treatment and participated in other drug clinical trials within four weeks.
- Has known central nervous system metastasis and/or spinal cord compression, cancerous meningitis, and pia mater disease.
- Has in screening period confirmed HCV positive, HIV positive, active syphilis positive, or HBsAg positive, HBV DNA titers >500 copies/ml and stable time <14 days after symptomatic treatment,or has a history of stem cells and organ transplantation.
- Has history of psychotropic substance abuse that unable to abstain from or mental disorder.
- According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Sites / Locations
- Anhui chest hospitalRecruiting
- Chinese PLA General Hospital
- Tumor hospital, Chinese academy of medical sciences
- Beijing Cancer HospitalRecruiting
- Fujian Tumor Hospital
- Affiliated tumor hospital of sun yat-sen universityRecruiting
- The first affiliated hospital of guangdong pharmaceutical universityRecruiting
- The first affiliated hospital of guangzhou medical collegeRecruiting
- Affiliated tumor hospital of Harbin medical universityRecruiting
- Henan Provincial People's Hospital
- Henan Tumor Hospital
- Hunan provincial tumor hospitalRecruiting
- Xiangya Hospital of Centre-south UniversityRecruiting
- Second hospital of jilin university
- The second affiliated hospital of dalian medical universityRecruiting
- Qilu Hospital of Shandong University
- Linyi tumor hospital
- Qingdao University Medical College Hospital
- Shanghai Jiaotong University Affiliated Chest HospitalRecruiting
- The first affiliated hospital of xi 'an jiaotong universityRecruiting
- Tianjin tumor hospital
- Sir Run Run Shaw Hospital School of Medical,Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Experimental
TQ-B3101
TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.