A phase II study of Osimertinib for untreated CNS metastasis, EGFR T790M-positive non-small cell lung cancer(LOGIK1603 / WJOG9116L)

Phase 2

• Conditions: EGFR-TKI treated T790M positive non-small cell lung cancer (NSCLC) with CNS metastasis (radiotherapy-naive)

• Registration Number: JPRN-UMIN000024218
• Lead Sponsor: Clinical Research Support Center Kyushu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-29
• Study Completion: 2022-01-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion 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 and heart failure 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. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified