Sept. 22, 2021 |
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Aug. 27, 2022 |
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jRCT2051210086 |
Phase II study of Sotorasib plus carboplatin-pemetrexed in advanced or recurrent chemotherapy naive non-squamous, non-small cell lung cancer patients harboring KRAS G12C mutation : SCARLET study (WJOG14821L) |
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Phase II study of Sotorasib plus carboplatin-pemetrexed in advanced or recurrent chemotherapy naive non-squamous, non-small cell lung cancer patients harboring KRAS G12C mutation : SCARLET study (WJOG14821L) |
Akamatsu Hiroaki |
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Department of Pulmonary Medicine and Oncology, Wakayama Medical University Hospital |
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811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan |
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+81-73-441-0619 |
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hiroakiakamatsu@gmail.com |
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Shimomura Mitsuru |
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West Japan Oncology Group |
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1-5-7, Motomachi, naniwa-ku, Osaka, Japan |
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+81-6-6633-7400 |
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WJOG14821L@wjog.jp |
Not Recruiting |
Oct. 01, 2021 |
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Oct. 20, 2021 | ||
30 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1) Patients who have personally provided written consent after receiving an adequate explanation on the contents of the clinical study prior to enrollment in the study. |
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1) Patients with active double cancer. |
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20age old over | ||
No limit | ||
Both |
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Non small cell lung cancer |
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Induction treatment; sotorasib + carboplatin + pemetrexed for 4 courses |
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Non small cell lung cancer, KRAS G12C |
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D002289 |
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Overall response by independent review |
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Overall response by investigators, Duration of response, Time to response, Disease control, Progression-free survival and Time to treatment failure (by independent review and investigators), Overall survival and Safety |
Amgen KK | |
Wakayama Medical University Hospital Institutional Review Board | |
811-1 Kimiidera, Wakayama, 641-8509, Japan, Wakayama | |
+81-73-447-2300 |
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Approval | |
No |
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none |