LOGIK1603/WJOG9116L (OCEAN study)

JRCT ID: jRCTs071180017

Registered date:13/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 27/12/2016
• Target sample size: 65
• Study type: Interventional
• Intervention(s): Osimertinib at the dose of 80mg/day is orally administered once daily and the administration is continued until progression disease (PD)

Outcome(s)

• Primary Outcome: Overall response rate (ORR) of metastatic brain tumor

Secondary Outcome

progression free survival (PFS),ORR, ORR of metastatic brain tumor (evaluated according to RECIST ver. 1.1), PFS of metastatic brain tumor, overall survival (OS), safety,
1st line treatment cohort:ORR of metastatic brain tumor ,progression free survival (PFS),overall survival (OS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically.
2) Patients with EGFR sensitive mutation (del19, L858R) detected in tumour tissue specimen or cytologic specimen.
3) Patients with treatment history of 1st generation and/or 2nd generation EGFR-TKI.
4) Patients with confirmation of EGFR T790M mutation positive after progression disease.
5) Patients with metastatic brain tumour (>= 5mm) with the major axis more than twice the slice width in MRI. However, patients required for urgent radiotherapy or surgical resection are ineligible.
6) Radiotherapy-naive for brain metastasis.
7) Patient is at least 20 years of age (at enrollment date).
8) Performance status (ECOG): 0-2
9) The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) meets the following all standard.
1.Neutrophil count >= 1,500/mm3
2.Haemoglobin >= 8.0g/dL
3.Platelet count >=100,000/mm3
4.AST, ALT <=100 IU/L
5.Total bilirubin <=1.5mg/dL
6.Creatinine<=1.5mg /dL
7.SpO2 >= 90%
10) Corrected QT interval (QTc) <= 470 msec.
11) Patients with life expectancy of at least 3 months.
12) Patients providing the written informed consent.

1st line treatment cohort
1) Patients with non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically.
2)Patients with stage IV or postoperative recurrence.
3) Patients with EGFR sensitive mutation (del19, L858R) detected in tumour tissue specimen or cytologic specimen.
4)Patients with no EGFR-TKI treatment.
5) Patients with metastatic brain tumour (>= 5mm) with the major axis more than twice the slice width in MRI. However, patients required for urgent radiotherapy or surgical resection are ineligible.
6) Radiotherapy-naive for brain metastasis.
7) Patient is at least 20 years of age (at enrollment date).
8) Performance status (ECOG): 0-2
9) The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) meets the following all standard.
1.Neutrophil count >= 1,500/mm3
2.Haemoglobin >= 9.0g /dL
3.Platelet count >=100,000/mm3
4.AST, ALT <=100 IU/L
5.Total bilirubin <=1.5mg /dL
6.Creatinine<=1.5 times ULN concurrent with creatinine clearance >=50mL/min
7.SpO2 >= 90%
10) Corrected QT interval (QTc) <= 470 msec.
11) Patients with life expectancy of at least 3 months.
12) Patients providing the written informed consent.

Exclude criteria

1) Symptomatic brain metastasis required for radiation therapy or surgical resection.
2) Patients with severe complication: such as myocardial infarction within 3 months, uncontrollable angina pectoris, heart failure, complete left bundle branch block, third degree heart block, second degree heart block, electrolyte abnormalities and long QT syndrome.
3) Patients with active double cancer (synchronous double cancer and asynchronous double cancer within 5 years of progression-free period. However, the lesions correspondent to carcinoma in situ and intramucosal carcinoma curable by topical treatment are excluded)
4) Treatment history of anti-PD-1 antibody, anti-PD-L1 antibody, anti- CD137 antibody or anti-CTLA-4 antibody.
5) Patients with pregnant or possibly pregnant.
6) Patients with nursing.
7) History of interstitial pulmonary disease, drug-induced interstitial pulmonary disease and irradiation pneumonitis required for steroidal treatment or any evidence of active interstitial lung disease.
8) Urgent radiotherapy because of symptom of superior vena cava syndrome.
9) Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom.
10) Any other patients who are regarded as unsuitable for this study by the investigators.
11) Patients with anamnesis of hypersensitivity to ingredients of the drug.

Related Information

• Primary Sponsor: Fukuda Minoru
• Source(s) of Monetary Support: AstraZeneca K.K.
• Secondary ID(s): UMIN000024218