Unique ID issued by UMIN | UMIN000038413 |
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Receipt number | R000043696 |
Scientific Title | Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy |
Date of disclosure of the study information | 2019/11/01 |
Last modified on | 2021/04/29 12:51:52 |
Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
NJLCG1901 Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
NJLCG1901 Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate efficacy and safety of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy
Safety,Efficacy
Overall Response Rate
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically or cytologically confirmed non-small cell lung cancer
2) Unresectable, locally advanced or metastatic non-small cell lung cancer
3) Patients with driver mutation/translocation negative or unknown
4) Patients who have worsened after the use of anti-PD-1/PD-L1 antibody plus chemotherapy for first-line treatment
5) Patients who are scheduled to start anti-PD-1/PD-L1 antibody re-treatment
6) At least one measurable lesion according to RECIST ver1.1 (within 28 days before enrollment)
7) Patients not younger than 20 years old at the time of informed consent
8) Life expectancy of at least 3 months
9) Patients providing written informed consent
1) Active double cancer
2) Patients with a history of severe immune-related adverse events associated with anti-PD-1/PD-L1 antibody
3) Patients with active autoimmune disease
4) Patients with infectious disease requiring systemic treatment
5) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis
6) Patients with significant complications
7) Patiens who are undergoing systemic administration of
steroid greater than 10mg daily of prednisone
8) History or severe drug allergies
9) Pregnant females, possibly pregnant females, females wishing to become pregnant, females of breastfeeding and males wishing to their partner's pregnant
10) Physician concludes that the patient's participation is inappropriate
70
1st name | Shunichi |
Middle name | |
Last name | Sugawara |
Sendai Kousei Hospital
Department of pulmonary medicine
9800873
4-15 Hirosemachi, Aobaku, Sendai, Miyagi
022-222-6181
swara357@sendai-kousei-hospital.jp
1st name | Yosuke |
Middle name | |
Last name | Kawashima |
Sendai Kousei Hospital
Department of pulmonary medicine
9800873
4-15 Hirosemachi, Aobaku, Sendai, Miyagi
022-222-6181
yousukekawashima3@yahoo.co.jp
North Japan Lung Cancer Study Group
None
Self funding
-
-
-
-
NO
2019 | Year | 11 | Month | 01 | Day |
Unpublished
Open public recruiting
2019 | Year | 10 | Month | 20 | Day |
2019 | Year | 10 | Month | 16 | Day |
2019 | Year | 10 | Month | 27 | Day |
2024 | Year | 12 | Month | 31 | Day |
None
2019 | Year | 10 | Month | 28 | Day |
2021 | Year | 04 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043696
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