Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer

Not Applicable

• Conditions: advanced EGFR mutation-positive non-squamous non-small cell lung cancer

• Registration Number: JPRN-UMIN000015414
• Lead Sponsor: Department of Thoracic Oncology Osaka Medical Center for Cardiovascular diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-11
• Study Completion: 2016-10-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1.EGFR mutation Exon20 T790M positive 2.Symptomatic brain metastasis and a spinal metastases requiring surgical treatment or irradiation 3.Less than 5 years of disease-free interval with other malignancy 4.Pleural effusion, ascites or pericardial fluid in need of treatment 5.SVC syndrome 6.Spinal cord compression with symptoms 7.Cerebrovascular disorder with aymptoms 8.Unhealed fracture 9.Severe infection 10.Planned surgery during the study period 11.Obvious interstitial lung disease 12.Severe gastrointestinal disorder 13.Symptomatic corneal disease 14.Severe cardiac disease 15.Clinically significant drug allergy 16.Prior EGFR-TKI therapy 17.During pregnabcy or lactating woman 18.Uncontrolled psychiatric disease 19.Other

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival, Response rate, Adverse events, QO