Unique ID issued by UMIN | UMIN000023433 |
---|---|
Receipt number | R000026982 |
Scientific Title | A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung |
Date of disclosure of the study information | 2016/11/01 |
Last modified on | 2020/06/06 15:35:21 |
A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung
Nivolumab for advanced sarcomatoid carcinoma of the lung
A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lung
Nivolumab for advanced sarcomatoid carcinoma of the lung
Japan |
advanced sarcomatoid carcinoma of the lung
Pneumology |
Malignancy
YES
To confirm effect and safety of nivolumab in patients with advanced sarcomatoid carcinoma of the lung.
Safety,Efficacy
Confirmatory
Phase II
Overall response rate by Central review
Overall response rate by investigator, PFS, OS, DCR, Survival rate at 6 months, and toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Medicine |
Nivolumab 3mg/kg every 2 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1. Histologically confirmed sarcomatoid carcinoma of the lung
2. Stage III, IV, and postoperative recurrence
3. Age > 20
4. PS 0-2
5. Measurable lesion
6. Adequate organ function
7. Written informed consent
1. Active auto-immune disease
2. Interstitial lung disease or pulmonary fibrosis
3. Active infection such as bacteria, HBV, or HCV
42
1st name | Yuichiro |
Middle name | |
Last name | Ohe |
National Cancer Center Hospital
Department of Thoracic Oncology
104-0045
Tsukiji 5-1-1, Chuo-ku, Tokyo
03-3542-2511
yohe@ncc.go.jp
1st name | Yutaka |
Middle name | |
Last name | Fujiwara |
National Cancer Center Hospital
Department of Thoracic Oncology
104-0045
Tsukiji 5-1-1, Chuo-ku, Tokyo
03-3542-2511
yutakafu@ncc.go.jp
National Cancer Center Hospital
National Cancer Center Hospital
Self funding
National Cancer center Hospital
Tsukiji 5-1-1, Chuo-ku, Tokyo
03-3542-2511
yutakafu@ncc.go.jp
NO
2016 | Year | 11 | Month | 01 | Day |
Unpublished
No longer recruiting
2017 | Year | 02 | Month | 23 | Day |
2017 | Year | 02 | Month | 23 | Day |
2017 | Year | 03 | Month | 27 | Day |
2023 | Year | 03 | Month | 31 | Day |
2016 | Year | 08 | Month | 01 | Day |
2020 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026982