Unique ID issued by UMIN | UMIN000006459 |
---|---|
Receipt number | R000007666 |
Scientific Title | Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment (TAILORED-2 study) |
Date of disclosure of the study information | 2011/10/03 |
Last modified on | 2011/10/03 12:55:02 |
Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment (TAILORED-2 study)
Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment (TAILORED-2 study)
Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment (TAILORED-2 study)
Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment (TAILORED-2 study)
Japan |
Non-Small Cell Lung Cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous and Non-Small Cell Lung Cancer not harboring EGFR mutation who failed to prior treatment
Safety
Exploratory
Phase II
Progression Free Survival
Response Rate
Disease Control Rate
Overall Survival
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Erlotinib 150mg/day, oral daily
Bevacizumab 15mg/kg, intravenous q3w
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically confirmed non-squamous NSCLC
2)StageIIIB/IV or postoperative recurrence of NSCLC
3)EGFR mutation (exon18,19,21) negative
4)Failed to prior chemotherapy or chemoradiotherapy(<3 regimens)
5)Measurable lesions(RECIST)
6)ECOG PS 0-2
7)Age>=20years
8)Expected survival over 3 months
9)Interval
i)Palliative radiation therapy
/More than 2 weeks
ii)Operation(except chest)
/More than 4 weeks
iii)Treatment of Brain metastasis
/More than 4 weeks
iv)Cranial nerves surgery
/More than 3 months
v)Thoracic drainage
/More than 2 weeks
vi)Incisional biopsy, Port detention, Measures against externally caused injury
/More than 2 weeks
vii)Aspiration cytology
/More than 1week
10)Adequate function of main organ
11)Provided written informed consent
1)Squamous cell carcinoma
2)Interstitial pneumonia or pulmonary fibrosis on chest CT scans
3)
i)Brain metastasis expected bleeding
ii)Patients with untreated Brain metastasis
4)Undergoing prior EGFR-TKI treatment
5)Active severe comorbidity disease.
6)History of hemoptysis
7)Uncontrollable hypertension
8)History of gastrointenstinal perforation or diverticulitis or fistula
9)Scheduled operation
10)History of grave drug allergic reaction.
11)Active concomitant malignancy
12)Pregnant or breast-feeding females
13)Inappropriate patients for this study judged by the physicians
38
1st name | |
Middle name | |
Last name | Koji Inoue |
Kitakyushu Municipal Medical Center
Respiratory medicine
2-1-1 Basyaku, Kokurakita-ku, Kitakyushu, JPAN, 802-0077
093-541-1831
1st name | |
Middle name | |
Last name | Taishi Harada |
Graduate school of medical science, Kyushu University
Research Institute for disease of the Chest
3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN, 812-8582
092-642-5378
Harada-t@kokyu.med.kyushu-u.ac.jp
Kyushu University
Kyushu University
Self funding
NO
九州大学(福岡県)、北九州市立医療センター(福岡県)
2011 | Year | 10 | Month | 03 | Day |
Unpublished
Open public recruiting
2011 | Year | 09 | Month | 10 | Day |
2011 | Year | 10 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2011 | Year | 10 | Month | 03 | Day |
2011 | Year | 10 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007666
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