The continuation of gefitinib treatment beyond progression in non-small cell lung cancer patients with EGFR mutation: A phase II single arm prospective study

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0003384
• Lead Sponsor: Samsung Medical Center

Brief Summary

In patients with EGFR-mutant NSCLC who experience progression, it is beneficial to maintain gefitinib treatment with local treatment such as radiotherapy until symptomatic progression. However, in patients with pleural metastasis or effusion, continuation of gefitinib beyond progression should be carefully determined. .

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-04-27
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

?Histologically confirmed stage IIIB/IV or recurrent NSCLC with activating EGFR mutation in exon 18 through exon 21 except T790M
?Patients who achieved complete/partial response more than 4 months or stable disease more than 6 months with first-line or second line gefitinib, Patients who experience disease progression by RECIST 1.1 criteria
?Age = 18years
?ECOG performance status of 0 to 2
?Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin =1.5 UNL; AST and/or ALT < 5 UNL, CCr = 50mL/min
? Gefitinib baseline adverse event = Grade 2
?Written informed consent form

Exclusion Criteria

?Prior treatment with EGFR TKI
?Patients who required dose reduction of gefitinib
?Surgery undertaken less than 4 weeks before the study
?Localized radiotherapy unless completed more than 2 weeks before the study
?Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
?Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method (hormonal or barrier methods))
?Uncontrolled symptomatic brain metastasis
?Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
?Concomitant use of CYP3A4 inducers/inhibitors
?Prolonged QT interval in ECG (QTc >450 msec)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified