Non-small cell lung cancer
Conditions
Interventions
Take gumarontinib 300mg once daily continuously until contrary to the discontinuation criteria.
Sponsors
Naoki Katsuhiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.A histologically or cytologically confirmed diagnosis of Non small cell lung cancer has been obtained. 2.The patient has intracranial metastases with a longest diameter of >=5mm on brain MRI. Patients with symptomatic brain metastases were eligible. CT is acceptable if MRI is unsuitable. Patients with untreated lesions were eligible after surgical resection or radiotherapy (local treatment) for brain metastases. Patients treated with whole brain irradiation is not eligible: However, if new or enlarging brain lesions are present, these cases might be eligible, contact the study office before enrollment. 3.The patient has stage IV disease with brain metastases or postoperative recurrence of brain metastases. 4.The patient was diagnosed as MET exon14 skipping mutation positive. 5.The patient received has no prior systemic therapy for lung cancer, except for neoadjuvant or adjuvant therapy. 6.The patient is >=18 years old on the date of informed consent. 7.Performance status (PS) is 0-2 according to ECOG criteria. 8.No severe dysfunction of major organs (bone marrow, heart, lungs, liver, kidneys, etc.) is present. 9.The patient is able to take oral medication. 10.The patient is expected to survive for at least 3 months. 11.If any of the following prior treatments or procedures were performed before enrollment, the required washout period: 1. History of neoadjuvant or adjuvant drug therapy, with >=180 days since the last dose. 2. Palliative radiotherapy for non CNS metastatic lesions, with >=7 days since the last irradiation. However, radiotherapy exceeding 30Gy to thoracic lesions within 168 days (24 weeks) before enrollment is excluded. 3. Stereotactic radiotherapy for intracranial metastases, with >=7 days since the last irradiation (patients may be enrolled if untreated lesions remain). 4. Drainage procedures: If drainage of pleural effusion, pericardial effusion, or ascites was performed for >=24 hours, >=7 days must have passed since cessation of drainage, and no Grade>=3 fluid accumulation has occurred after cessation. No washout period is required if drainage lasted =7 days since the procedure. 6. Blood transfusion or administration of hematopoietic growth factors, with >=7 days since the last administration. 7. Surgical treatment under general anesthesia, with >=7 days since the procedure. 12.Written informed consent for participation in this study has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1.Has intracranial metastases requiring urgent radiation therapy or surgical resection. 2.Has hypersensitivity to any drug used in this study. 3.Has interstitial lung disease . 4.Has developed symptomatic congestive heart failure, unstable angina, myocardial infarction, or symptomatic cerebrovascular disease within 3 months prior to enrollment. 5.Has uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg persisting for more than 4 weeks). 6.Has uncontrolled diabetes mellitus (persistent hyperglycemia exceeding 250 mg/dL despite appropriate treatment). 7.Has infectious diseases requiring systemic therapy 8.Has active hepatitis B or hepatitis C (patients who are HBs antigen positive may be eligible if hepatitis is not active). Note: Patients without prior testing (HBs antigen, HBs antibody, HBc antibody, HCV antibody) are considered to be ineligible. 9.Has active double cancer (defined as synchronous double cancer or metachronous double cancer with a disease free interval of 2 years or less, requiring treatment). Lesions judged to be cured by local therapy, such as carcinoma in situ or mucosal level cancer, are not considered active double cancer. 10.Is taking drugs that are substrates of MATE1 or MATE2-K (metformin, pilsicainide, procainamide), because the study drug inhibits MATE1 and MATE2-K. However, patients may be enrolled if these medications can be switched to alternatives at Enrollment so that they are not used concurrently with the protocol treatment. 11.Pregnant or breastfeeding women, and women who are unwilling to use contraception throughout the study treatment period. 12.Men who are unwilling to use contraception throughout the study treatment period. 13.Has psychiatric disorders or psychiatric symptoms that interfere with daily life and are judged to make participation in the study difficult. 14.Any other patient deemed inappropriate for participation in this study by the principal investigator or sub investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate of intracranial metastases (assessed by the central imaging review committee using the RANO-BM criteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival of intracranial metastases(RANO-BM criteria) Systemic objective response rate(RECIST) Systemic progression-free survival(RECIST) Overall survival Safety | — |
Countries
Japan, non
Contacts
Public ContactYoshiro Nakahara
Kitasato University Hospital
Outcome results
None listed