EGFR mutation-positive non-squamous non-small cell lung cancer
Conditions
Interventions
Sponsors
Ryo Toyozawa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed non-squamous NSCLC 2) Cases of postoperative recurrence or progressive disease (stage IIIB, IIIC or IV) 3) Confirmed EGFR mutation positivity (exon 19 deletion or exon 21 L858R mutation) at the time of receiving 1st line treatment 4) Treated with osimertinib in the 1st line and confirmed to have progressive disease at the time of study enrollment 5) Capability to provide two tubes of whole blood (EDTA-2Na collection tube, in 2 tubes, 8 mL/tube) and tumor tissue (formalin-fixed paraffin-embedded, in 10 slices, 4-5 maicrom thickness each) collected at the time of progressive disease 6) progressive disease within 8 weeks of the study enrollment 7) Measurable disease by RECIST ver. 1.1 8) Age: >20 years 9) ECOG PS: 0 or 1 10) Adequate functions of major organs (e.g. bone marrow, heart, lung, liver, kideney) 11) Life expectancy >90 days at the time of study enrollment 12) Willingness to sign informed consent form
Exclusion criteria
Exclusion criteria: 1)Complications in lungs such as ILD, COPD, phenmoconiosis, or drug-induced pneumonia that is clinically symptomatic or assessed by chest CT 2)Uncontrollable pleural effusion, ascites, and pericardial effusion 3)Symptomatic brain metastases or cancer-related meningitis. Patients who undergo local treatment of brain metastases and have stable symptoms are permitted to participate in the study 4)History of radiation treatment (including lung) 4 weeks prior to the study enrollment 5)Major surgery within 4 weeks of the study enrollment 6)Having multiple active cancers 7)Active infections that require the treatment with antibiotics, antifungal drugs, and antiviral drugs 8)Serious complications (e.g. GI bleeding, heart disease, glaucoma, diabetes mellitus) 9)History of severe allergy 10)Current continuous treatment with steroids 11)Mental illness judged to be clinical inadequate for enrolling in the study 12)Females who are pregnant, lactating, or have possibility to be pregnant. Females and males who are unwilling to take contraceptives 13)Inappropriate for the study judged by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Genetic alterations analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, progression-free survival, time-to-treatment-failure, overall survival, safety | — |
Contacts
Public ContactRyo Toyozawa
National Hospital Organization Kyushu Cancer Center
Outcome results
None listed