A PHASE III, randomized, open-label, multicenter study evaluating the efficacy and safety of Divarasib versus Sotorasib or Adagrasib in patients with previously treated KRAS G12C-positive advanced or metastatic non-small cell lung cancer, EU CT Number: 2024-510908-37-00

Leitung: Prim. –Priv. –Doz.Dr. Georg-Christian Funk
Vertretung: Dr. Nino Müser
Studienkoordination: Almas Merchant, M.P.H.
Start: 2024
Projektmitglieder an der Klinik Ottakring: Dr. Klaus Kirchbacher, OÄ. Dr. Elena Egger, Dr. Nino Müser, Almas Merchant, M.P.H

Projektinformation/Beschreibung/Zielsetzung:

The purpose of this study is to assess the efficacy and safety of divarasib, a Kirsten rat sarcoma virus oncogene homolog glycine 12 to cysteine (KRAS G12C) inhibitor, compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in patients with KRAS G12C-positive (KRAS G12C  ) advanced or metastatic non-small cell lung cancer (NSCLC) who have been previously treated with standard of care treatments in the advanced or metastatic setting. Recently, several KRAS G12C inhibitors have been developed and studied in this patient population; however, the available data to date indicate that an unmet medical need still exists, and that more efficacious KRAS G12C inhibitors with acceptable safety profile and tolerability could improve the long-term outcome for patients.