A phase II study of dacomitinib in advanced EGFR-mutant non-small cell lung cancer (NSCLC) patients who have non-irradiated brain metastasis
- Conditions
- Neoplasms
- Registration Number
- KCT0005748
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
?Biopsy proven recurrent or metastatic NSCLC (adenocarcinoma) with major EGFR mutation (exon 19 deletion or Leu858Arg mutation without the Thr790Met)
?No prior systemic treatment of advanced NSCLC (Neoadjuvant or , adjuvant chemotherapy, or definitive concurrent chemoradiotherapy are allowed, without limitation on its treatment timing)
?Age =20 years
?ECOG performance status of 0 to 1
?Had at least one measurable intracranial lesion as = 5mm in the longest diameter by magnetic resonance imaging (MRI) (at least twice the slice thickness of 2.5mm of MRI), which checked within 8 weeks before enrollment.
?A brain lesion that has more than five
?Adequate organ function as evidenced by the following;
?Female subjects must either be of non-reproductive potential
?Subject is willing and able to comply with the protocol
? Signed written informed consent
?Severe symptomatic brain metastasis, needing urgent control with radiotherapy or high dose steroid: the definition of high dose steroid is the equivalent dose of dexamethasone 10 mg or higher per day (mild symptoms controlled with low dose of steroid can be enrolled)
?With leptomeningeal seeding
?Exposure to EGFR-TKIs or other EGFR targeting agents at any time in either neoadjuvant or adjuvant setting
?Local treatment (SRS or WBRT) for brain metastases
?Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection.
16Past medical history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis which required steroid treatment
17 In case of laboratory abnormalities or other abnormalities that may affect the results of the study in the judgment of the tester, or if there is a history of the present or past.
18 In the case of a psychiatric disorder or a disorder, such as drug abuse, that may interfere with the requirements and cooperation of clinical trials.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method