Epidermal growth factor receptor activating mutation positive (EGFRm +) advanced non-small-cell lung cancer (NSCLC)
Conditions
Interventions
None listed
Sponsors
Public Health Research Foundation, Comprehensive Support Project for Oncology Research (CSPOR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients diagnosed with advanced or recurrent non-small cell lung cancer prior to enrollment in the study. * Use disease stages defined in the Union for International Cancer Control (UICC) TNM Classification of Lung Tumors (2017, 8th Edition). (2)Patients diagnosed with positive EGFR mutations of any type. In addition to Exon 19 deletion and Exon 21 L858R common mutations, rare EGFR mutations (uncommon mutation) are also eligible. (3)Patients who have been treated with primary EGFR TKI since September 1, 2018, those who had been treated, and those who will be treated in the future. 1. Patients using anticancer agents as local therapy, such as pleurodesis, are also eligible. 2. Patients using cytotoxic anticancer agents as prior therapy are also eligible. 3. Patients treated in combination with EGFR-TKIs and other anticancer drugs or angiogenesis inhibitors are eligible. 4. Patients using single-agent EGFR-TKI as the mainstay treatment are eligible, even if it's a rotation therapy of EGFR-TKI and other anticancer agents. 5. Patients enrolled in other clinical trials are also eligible. (1)Patients aged 20 years or older at the time of enrollment. (2)Patients who have given written consent to this study (however, patients who have died at the time of enrollment will not need consent).
Exclusion criteria
Exclusion criteria: (1) atients whose treatment date for EGFR TKIs was prior to September 1, 2018. Patients judged by the physician to be inappropriate for enrollment in the study. (2) Patients judged by the physician to be inappropriate for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (time from initiation of osimerutinib treatment to RECIST PD or death from any cause) Percentage of patients with the following progression patterns when osimertinib treatment results in RECIST PD. Patterns of progression are classified into nine categories (3x3) according to the following criteria for site of progression and patient status: A. Exacerbation pattern for the site of exacerbation (A1) brain metastases only (A2) oligometastasis (one non-brain organ, 1-3 lesions) (A3) Multiple organ exacerbations (other than A1 and A2) B. Exacerbation patterns according to symptoms at exacerbation and the patient's general condition (B1) Asymptomatic, no clinical progression defined by B3 (B2) Present symptoms, no clinical progression defined by B3 (B3) Reduced PS and/or threatened major organs (carcinomatous lymphangiosis, bone marrow metastases, carcinomatous meningitis, liver metastases with liver damage, etc.) | — |
Countries
Japan
Contacts
Public ContactAkira Yamao
Public Health Research Foundation Comprehensive Support Project for Oncology Research (CSPOR)
Outcome results
None listed