Phase III clinical trial - Appareil pulmonaire

GeoMETry-III (CINC280A2301)
Appareil pulmonaire
Ouvert depuis le: 09.19.2021
Site: Paris
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A phase III, randomized, controlled, open-label, multicenter,;global study of capmatinib versus SoC docetaxel;chemotherapy in previously treated patients with EGFR wt,;ALK negative, locally advanced or metastatic (stage IIIB/IIIC;or IV) NSCLC harboring MET exon 14 skipping mutation;(METÀex14)
Description de l'essai

The purpose of the study is to learn whether the study drug (capmatinib) helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients suffering from a particular type of lung cancer. This type of cancer is called non-small cell lung cancer (NSCLC) with certain specific genetic alterations (called mutations) of a gene called MET, within a specific part of the gene called exon 14.;Approximately 90 people with advanced or metastatic lung cancer, with these specific mutations in the MET gene but without changes in their epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genes, will be enrolled in this study.;The study drug, capmatinib (also known as INC280), is an oral drug that is called a 'targeted' medicine, which means it targets particular processes that may not be working properly in cancer cells (called dysregulation). The dysregulation of the MET signaling in cancer cells of patients with NSCLC is believed to make the cancer worse. Capmatinib has been shown to selectively block the effects of the MET gene and therefore may help in keeping the disease under control, stopping cancer cells from growing. Docetaxel is a standard chemotherapy medicine commonly used to treat your type of lung cancer. This standard, anti-cancer medicine is a cytotoxic chemotherapy.;The reason for this study is to find out if capmatinib can control lung cancer better.;Patients will be randomly assigned to get either capmatinib or docetaxel in a 2 to 1 ratio:;ÀCapmatinib: 2 out of 3 possibility or 66% chance of getting this treatment,;ÀDocetaxel: 1 out of 3 possibility or 33% chance of getting this treatment.;During treatment, visits will be scheduled every 21 days.