non-squamous non-small cell lung cancer harboring EGFR active mutation
Conditions
Interventions
Sponsors
North East Japan Study Group (NEJSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, histologically or cytologically confirmed non-squamous non-small cell lung cancer 2, Stage IIIB, IIIC, IVA and IVB without indication of curative therapy or postoperative recurrent condition (UICC 8th) 3, EGFR active mutation i.e. exon 19 deletion or exon 21 L858R point mutation (a patient with complex mutations is excluded except for the combination of exon 19 deletion and exon 21 L858R point mutation) 4, One or more mesurable lesion(s) 5, chemotherapy-naive patient (Any preoperative or postoperative chemotherapy given at least 6 months before enrollment in the present study is eligible) 6, Aged 20 or older at the time of informed consent 7, Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 8, Adequate oral intake 9, Adequate organ function 10, All of the following criteria are met based on the latest data obtained within 14 days before enrollment: 1) Neutrophil count >= 1,500/mm^3 2) Hemoglobin >= 9.0 g/dL 3) Platelet count >= 10*10^4/mm^3 4) Total bilirubin <= 1.5 mg/dL (<= 2.0 mg/dl in case liver metastases is present) 5) AST(GOT) <= 2.5 X ULN and ALT(GPT) <= 2.5 X ULN (<= 5.0 X ULN if liver metastases is present) 6) Creatinine <= 1.5 X ULN 7) SpO2 >= 95% in room air or PaO2 is 80 torr or more. 8) Urinary protein is 1+ or less. 11, At the time of registration, the following period should elapse since the end of the following prior treatment: Palliative radiation therapy: 2 weeks or more. Surgical therapy (including examination or exploratory thoracotomy): 4 weeks or more. Thoracic / cardiac drainage therapy: 2 weeks or more. 12, Estimated life expectancy should be more than 90 days from the date of registration. 13, Have given written consent to participate in the study after receiving detailed explanation of the study.
Exclusion criteria
Exclusion criteria: 1, Evident pulmonary fibrosis or interstitial lung disease on chest X-ray 2, History of radiotherapy for primary lesion (Eligible if primary lesion is out of radiation field) 3, Presence or past history of hemoptysis (>= 2.5 ml) 4, Predisposing factor of airway bleeding i.e. disorder of coagulation, tumor invasion to major vessels, evident cavitary lesions, and tumor invasion of bronchus mucosa 5, Symptomatic central nervous system metastases 6, Active infectious disease (excluding viral hepatitis) 7, Severe complication (congestive heart failure, chronic renal failure, chronic liver failure, bleeding peptic ulcer, paralysis of intestine, ileus, uncontrollable diabetes mellitus, and so on) 8, Ascites or pleural effusion requiring drainage 9, Active double cancer 10, Elective surgery after enrollment of the study 11, Pregnant or lactating females, females of child-bearing potential, and males desiring partner's pregnancy 12, Severe mental disorder 13, Severe drug hypersensitivity 14, Active hepatic disease 15, Any other condition unsuitable for enrolling the study judged by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) Disease Control Rate (DCR) Overall Survival (OS) Safety profiles | — |
Countries
Japan
Contacts
Public ContactHiroshige Yoshioka
Kansai Medical University Hospital Department of Thoracic Oncology
Outcome results
None listed