Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma

This is a phase 2, multicenter and open-label study of first-line chemotherapy (gemcitabine combined with nab-paclitaxel \[gem/nab-P\] or modified FOLFIRINOX \[mFOLFIRINOX\]) in combination with sotorasib for patients with advance pancreatic cancer harboring KRAS p.G12C mutation.The study will be conducted at approximately 25 sites distributed in two countries (Spain and France). The study will consist of a screening period, a treatment period, a safety follow-up (SFU) and long-term follow-up (LTFU) period. A minimum of 6 and a maximum of 15 patients will be enrolled to receive first-line chemotherapy (gem/nab-P or mFOLFIRINOX) in combination with sotorasib 960 mg daily (QD). An interim safety analysis will be conducted by an independent data monitoring committee (DMC) DMC after the first 3 evaluable patients treated with sotorasib combined with gem/nab-P and an additional interim safety analysis with the first 3 evaluable patients treated with sotorasib combined with mFOLFIRINOX have been treated for at least 1 month, respectively. Patients may discontinue treatment because of disease progression, intolerance of treatment leading to treatment discontinuation, initiation of another anticancer therapy, or withdrawal of consent.