A Phase 2 Study of Osimertinib for Advanced NSCLC with Malignant Pleural Effusion Harboring EGFR T790M mutatio

Not Applicable

• Conditions: non-small cell lung cancer

• Registration Number: JPRN-UMIN000026669
• Lead Sponsor: The Japan-Multinational Trial Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with a history of severe allergy or hypersensitivity to the ingredients of the drugs used 2) Cases with pleurodesis 3) Case of treatment history of Osimeltinib and other third generation EGFR-TKI 4) Patients treated with immune checkpoint inhibitors 5) Cases with major surgery within 4 weeks 6) Patients who are concomitantly taking drugs with strong inducing action on cytochrome P450 (CYP) 3A4 or supplements of Chinese traditional herbs (or patients who can not be discontinued at least 1 week before the first dose) 7) Cases with complications of malignancy and / or other active malignant tumors requiring treatment within one year prior to the first dose 8) Cases with serious complications 9) Examples of symptomatic brain metastasis and spinal cord pressure exclusion (cases that can be controlled by treatment can be registered) 10) Cases with obvious interstitial pneumonia or pulmonary fibrosis in chest CT or cases with a history of interstitial pneumonia 11) Patients with a history of gastrointestinal resection such as refractory nausea and vomiting, chronic gastrointestinal disorder, inability to swallow or absorption possibly significantly affecting absorption of osimertinib 12) Case in which QTc value is 470 msec or more in electrocardiogram examination at screening 13) Case with corneal ulcer 14) Cases with difficult ingestion 15) Pregnant women or lactating women 16) Other cases, cases in which doctor in charge judged inappropriate as the subject of this study (examples where dementia patients or psychiatric patients are difficult to perform the test)

Study & Design

• Study Type: Interventional
• Study Design: Not specified