An Evaluation of tumor response to osimertinib by early FDG-PET finding in patients with T790M positive EGFR mutated non-small cell lung cancer

Not Applicable

• Conditions: T790M (detected by cobas EGFR Mutation Test v2) from the relapsed tumor after EGFR-TKI therapy.

• Registration Number: JPRN-UMIN000027550
• Lead Sponsor: Department of Comprehensive Cancer Therapy, Shinshu University School of Medicine, 3-1-1, Asahi Matsumoto, 390-8621, Japan,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-03
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1.past history of hypersensitivity to drugs; 2.Double cancers, 3.Severe complications (for example, heart failure, renal failure, liver failure, severe diabetes mellitus, etc.); 4.Active infection including hepatitis B, hepatitis C and HIV. 5.Interstitial lung disease detectable on chest radiography or past history of interstitial lung disease during prior EGFR-TKIs therapy; 6.Pleural, pericardial, or peritoneal effusion requiring drainage; 7.Active brain metastasis; 8.Pregnancy or female with planning pregnancy. Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry 9.Any of the following cardiac criteria: -Mean resting corrected QT interval: >470 msec, -Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) -Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. 10. Treatment history of immune-check point inhibitors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to evaluate the correlation between the SUVmax reduction rate and tumor size reduction rate.

Secondary Outcome Measures

Name	Time	Method
to evaluate the correlation between the SUVmax reduction rate and progression-free survival (PFS) in targeted lesions.