Unique ID issued by UMIN | UMIN000017877 |
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Receipt number | R000020713 |
Scientific Title | First-line afatinib in patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations; non-randomized phase II trial |
Date of disclosure of the study information | 2015/08/01 |
Last modified on | 2021/06/15 10:32:23 |
First-line afatinib in patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations; non-randomized phase II trial
First-line afatinib for elderly patients
First-line afatinib in patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations; non-randomized phase II trial
First-line afatinib for elderly patients
Japan |
patients aged 75 or older with advanced non-squamous non-small cell lung cancer harboring EGFR mutations
Pneumology | Adult |
Malignancy
NO
Data on efficacy and safety of afatinib for patients aged 75 years or older will be collected and evaluated.
Safety,Efficacy
Phase II
Overall Response Rate
Progression Free Survival
Time to Treatment Failure
Overall Survival
Disease Control Rate
1 and 2 Year Survival Rate
Adverse Event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
afatinib 40mg/1x
75 | years-old | <= |
Not applicable |
Male and Female
1. Histologically or cytological confirmed stage III/IV non-small cell lung cancer
2. Patients having EGFR mutation (exon 19 deletion or L858R)
3. No prior chemotherapy and no prior treatment with EGFR targeting small molecules or antibodies.
4. Measurable lesion for RECIST(ver 1.1)
5. Patients aged 75 years or older
6. ECOG performance status 0 to1
7. Adequate organ function
8. Life expectancy more than three months
9. Written informed consent
1. Chemotherapy, biological therapy or investigational agents for other carcinomas within four weeks prior to the start of study treatment. Hormonal treatment within 2 weeks prior to start of study treatment
2. Previous radiotherapy to the primary tumor or mesurable lesion
3. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
4. Patients with active lung disease such as interstitial pneumonia, active radiation pneumonitis, or drug-induced pneumonitis
5. Massive pleural or pericardial effusion, or ascites
6. Symptomatic brain metastases
7. Any history or presence of poorly controlled diseases that could affect the absorption of the study drug
8. Active infection, active hepatitis B infection, active hepatitis C infection and/or known HIV carrier.
9. Other concurrent active malignancy
10. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug
11. Pregnancy
12. Clinically significant phycological problem
13. Patients with uncontrollable complications
14. Known hypersensitivity to afatinib or the excipients of any of the trial drugs
35
1st name | Akihiko |
Middle name | |
Last name | Gemma |
Graduate school of medicine, Nippon medical school
Department of pulmonary medicine and oncology
113-8603
1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
03-3822-2131
agemma@nms.ac.jp
1st name | Yuji |
Middle name | |
Last name | Minegishi |
Graduate school of medicine, Nippon medical school
Department of pulmonary medicine and oncology
113-8603
1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
03-3822-2131
yminegis@nms.ac.jp
Non Profit Organization North East Japan Study Group
Nippon Boehringer Ingelheim Co., Ltd.
Profit organization
Nippon Medical School Hospital, Center for Clinical Research
1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
03-3822-3131
app-ccr@nms.ac.jp
NO
2015 | Year | 08 | Month | 01 | Day |
Unpublished
38
Patients characteristics N=38 (SAS)
Gender:Male/Female 12/23
Age:median(range) 77 (75-91) years
Smoking status:Never 26(68.4%)
ECOG PS:0/1 21/17
EGFR mutation type:ex19del/L858R 23/15
Promary endpoint
Objective response rate:75.7% (95%CI 58.8-88.2%)
Secondary endpoint
Disease control rate:33% (74.6-97.0%)
Adverse event:
All garade 100%, grade3/4 63.2% Grade5 0%
2019 | Year | 06 | Month | 17 | Day |
Main results already published
2015 | Year | 05 | Month | 18 | Day |
2015 | Year | 03 | Month | 27 | Day |
2015 | Year | 08 | Month | 01 | Day |
2019 | Year | 09 | Month | 30 | Day |
2015 | Year | 06 | Month | 11 | Day |
2021 | Year | 06 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020713
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