Unique ID issued by UMIN | UMIN000043958 |
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Receipt number | R000050175 |
Scientific Title | Exploratory research of immunochemotherapy for advanced non-small cell lung cancer patients; prospective observation study |
Date of disclosure of the study information | 2021/04/19 |
Last modified on | 2022/10/18 21:15:35 |
Exploratory research of immunochemotherapy for advanced non-small cell lung cancer patients; prospective observation study
Prospective resaerch of immunochemotherapy for advanced NSCLC patients
Exploratory research of immunochemotherapy for advanced non-small cell lung cancer patients; prospective observation study
Prospective resaerch of immunochemotherapy for advanced NSCLC patients
Japan |
Non small cell lung cancer
Pneumology |
Malignancy
NO
To investigate the efficacy and safety of combination therapy with immune checkpoint inhibitors and chemotherapy in advanced stage or postoperative recurrent non-small cell lung cancer
Safety,Efficacy
Progression-free survival
Overall survival, response rate, disease control rate, time to treatment failure, and incidence and grade of adverse events including immune-related adverse events
Association of PD-L1 expression in tumors with response to combined chemoimmunotherapy
Association between treatment response and patient background for combined chemoimmunotherapy
Observational
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients aged 20 years or older with PS0-2 at the time of consent
(2) Patients with advanced or recurrent non-small cell lung cancer that is not curatively resectable
(3) Patients with evaluable lesions by RECIST (version 1.1)
(4) Patients who are scheduled to receive combination therapy with immune checkpoint inhibitors and chemotherapy
(5) Patients whose tumor PD-L1 protein expression has been examined using formalin-fixed paraffin-embedded blocks in areas that do not interfere with pathological diagnosis, and whose consent has been obtained from the patient.
(6) Patients who have been fully informed about the contents of this clinical study and have given free written consent from the research subject.
(1)Patients with a history of treatment with systemic chemotherapy or immune checkpoint inhibitors (However, molecularly targeted cancer drugs for patients with driver gene mutation positive, and postoperative adjuvant chemotherapy for patients with postoperative recurrence are acceptable)
(2)Other patients who are deemed inappropriate by the physician in charge.
100
1st name | Tadaaki |
Middle name | |
Last name | Yamada |
Kyoto Prefectural University of Medicine
Pulmonary Medicine
602-8566
465, Kajii-cho, Kamigyo-ku, Kyoto
0752515513
tayamada@koto.kpu-m.ac.jp
1st name | Yuki |
Middle name | |
Last name | Katayama |
Kyoto Prefectural University of Medicine
Pulmonary Medicine
602-8566
465, Kajii-cho, Kamigyo-ku, Kyoto
0752515513
ktym2487@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
Kyoto Prefectural University of Medicine
Self funding
Kyoto Prefectural University of Medicine
465, Kajii-cho, Kamigyo-ku, Kyoto
0752515513
rinri@koto.kpu-m.ac.jp
NO
2021 | Year | 04 | Month | 19 | Day |
Unpublished
100
No longer recruiting
2019 | Year | 09 | Month | 05 | Day |
2019 | Year | 09 | Month | 30 | Day |
2019 | Year | 11 | Month | 01 | Day |
2022 | Year | 09 | Month | 30 | Day |
None
2021 | Year | 04 | Month | 17 | Day |
2022 | Year | 10 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050175
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