Afatinib and selumetinib in advanced KRAS mutant positive and PIK3CA wildtype non-small cell lung cancer and colorectal cancer

ABSTRACT: Primary objectives: Part A: To determine the recommended phase 2 dose and schedule (RP2D) of the selumetinib/afatinib combination in patients with KRASm and PIK3CAwt NSCLC and CRC Part B: To determine the progression free survival (PFS) of the selumetinib/afatinib combination compared to standard of care therapy in patients with KRASm and PIK3CAwt , NSCLC and CRC Primary endpoints: Part A: Incidence of dose-limiting toxicities (DLTs) Part B: Progression free survival (PFS) per RECIST version 1.1

DISEASE(S): Colorectal Adenocarcinoma,Patients With Histological Or Cytological Proof Of Advanced Kras Mutant And Pik3ca Wildtype Non Small Cell Lung Cancer (nsclc) And Colorectal Cancer (crc). In Part B: For Which First-line Treatment Failed.,Non-small Cell Lung Cancer Recurrent,Metastatic Colorectal Cancer,Non-small Cell Lung Cancer Stage Iv,Non-small Cell Lung Cancer Stage Iii,Colorectal Cancer,Non-small Cell Lung Cancer Stage Iiia,Non-small Cell Lung Cancer Stage Iiib,Colorectal Cancer Stage Iii,Colorectal Carcinoma,Colorectal Cancer Stage Iv,Colorectal Neoplasms Malignant,Non-small Cell Lung Cancer Metastatic,Colorectal Cancer Recurrent,Colorectal Cancer Metastatic,Non-small Cell Lung Cancer Stage Ii

PROVIDER: 2533271 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR