A phase II study of osimertinib in patients with poor performance status and non-small-cell lung cancer

Phase 2

• Conditions: EGFR mutation T790M-positive non-small-cell lung cancer; non-small-cell lung cancer, EGFR T790M mutation-positive

• Registration Number: JPRN-jRCT1041180081
• Lead Sponsor: Murakami Haruyasu

Brief Summary

Osimertinib therapy demonstrated favorable efficacy and safety outcomes in patients with EGFR T790M mutation-positive advanced non-small cell lung cancer that have a poor PS.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-12
• Study Completion: 2019-06-30
• Results First Posted: 2020-05-18
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1)ECOG PS 2, 3, or 4
2)Pathologically confirmation of non squamous non-small-cell lung cancer
3)Advanced non-small-cell lung cancer
4)History of using first-generation or second-generation EGFR-TKI
5)EGFR mutation with T790M in exon 20
6)Aged 20 or more
7)Written informed consent

Exclusion Criteria

1)History of using third-generation EGFR-TKI
2)Uncontrolled symptomatic brain metastasis
3)Interstitial pneumonia or pulmonary fibrosis on imaging
4)QTc > 500 msec
5)Gastrointestinal disorder
6)Uncontrollable pleural effusion , ascites or pericardial effusion
7)Receiving the radiation therapy for chest
8)Severe complication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival

Secondary Outcome Measures

Name	Time	Method
Safety, Response rate, Improvement rate of performance status, Overall survival