--- a +++ b/clusters/9knumclustersv2/clust_140.txt @@ -0,0 +1,41 @@ +History of interstitial lung disease or pneumonitis requiring supplemental oxygen or treatment with oral or intravenously administered corticosteroids +Has active pneumonitis requiring treatment with steroids or active interstitial lung disease +Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis. Patients with a history of prior radiation pneumonitis are not excluded. +History of or active pneumonitis or interstitial lung disease:\r\n* For history of pneumonitis to be an exclusion, patient had to have required supplemental oxygen or corticosteroid treatment; radiographic changes alone are not an exclusion +Has interstitial lung disease that has required oral or intravenous glucocorticoids to assist with management. +History of interstitial pneumonitis +Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. +Current or history of interstitial pneumonitis, +Patients with active interstitial lung disease and non-infectious pneumonitis or a history of active interstitial lung disease or pneumonitis requiring treatment with steroids or that may interfere with the detection or management of suspected drug-related pulmonary toxicity. Patients with lung cancer with a remote history of pneumonitis following chemo-radiation treatment that has resolved are allowed.\r\n* Note: Patients with chronic obstructive pulmonary disease (COPD) whose disease is controlled (per investigator judgment) at trial entry are not excluded. +Subjects with active interstitial pneumonitis. +Patients with a known history of severe interstitial lung disease or severe pneumonitis or active pneumonitis/pneumonia or pulmonary pathology that is not well controlled in the opinion of the treating physician and/or principal investigator (PI). +History of pneumonitis or drug-related inflammatory lung disease +History or the presence of pulmonary interstitial disease, or drug-related pneumonitis +Patients with a known history of severe interstitial lung disease or severe pneumonitis or active pneumonitis/pneumonia or pulmonary pathology that is not well controlled in the opinion of the treating physician and/or principal investigator (PI) +Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management; lymphangitic spread of the NSCLC is not exclusionary +Patients with history of interstitial lung disease or active, non-infectious pneumonitis are not eligible\r\n* NOTE: history of radiation pneumonitis in the radiation field (fibrosis) is permitted +Has known history of/active pneumonitis requiring treatment with steroids or history of/active interstitial lung disease +CERITINIB EXCLUSION CRITERIA: Known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis +REGORAFENIB EXCLUSION CRITERIA: Known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis +ENTRECTINIB EXCLUSION CRITERIA: Known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis +Patients with a known history of severe interstitial lung disease or severe pneumonitis or active pneumonitis that is uncontrolled in the opinion of the treating physician +Currently have or have a history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis that required steroid treatment. +Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at screening period +History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last years +Has interstitial lung disease or a history of pneumonitis that required oral of IV glucocorticoids to assist with management. +Have a history or the presence at baseline of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis. +Interstitial lung disease (subjects with existing pneumonitis as a result of radiation are not excluded, however, subjects cannot be oxygen dependent). +Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids +Patients with a known history of severe interstitial lung disease or severe pneumonitis or active pneumonitis that is uncontrolled in the opinion of the treating physician +Interstitial lung disease or pneumonitis that has required oral or IV steroids +Patients with active interstitial pneumonitis +Has a history of interstitial lung disease, idiopathic pulmonary fibrosis, pneumoconiosis, non-infections pneumonitis, radiation-induced or drug-induced pneumonitis +Participant has history of interstitial lung disease (ILD) OR a history of pneumonitis that has required oral or IV steroids. Participants whose pneumonitis was solely as a result of radiation therapy for their NSCLC would not be excluded from the study unless they received oral/IV steroids to manage the pneumonitis. +Have a history or the presence of pulmonary interstitial disease or drug-related pneumonitis. +History of interstitial pneumonitis +History of interstitial pneumonitis +Patients with interstitial pneumonitis +Has a history of, active pneumonitis requiring treatment with steroids or history of/active interstitial lung disease +Known interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment +Interstitial lung disease (subjects with existing pneumonitis as a result of radiation are not excluded, however, subjects must not be oxygen dependent). +History of (current and past) idiopathic pulmonary fibrosis, pneumonitis (for past pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia. Note: post-radiation changes in the lung related to prior radiotherapy and/or asymptomatic radiation-induced pneumonitis not requiring treatment may be permitted if agreed by the investigator and Medical Monitor.