Clinical trial of GFH925 in combination with cetuximab in patients with previously untreated advanced stage KRAS G12C mutated NSCLC

THE OBJECTIVE OF THIS STUDY IS TO EXAMINE AN INVESTIGATIONAL DRUG, GFH925, WHEN USED IN COMBINATION WITH AN ANTINEOPLASTIC CALLED "CETUXIMAB", IN PEOPLE WITH A PARTICULAR TYPE OF NSCLC, CALLED "NSCLC WITH KRAS G12C MUTATION". THE KRAS G12C MUTATION IS A TYPE OF MUTATION OF A GROUP OF GENES THAT CONTROL CELL GROWTH AND DIVISION. GENES ARE SEGMENTS OF DEOXYRIBONUCLEIC ACID (DNA), WHICH IS PRESENT IN MOST CELLS. GENES DECIDE THE FUNCTION AND ACTIONS OF THE CELL. WHEN MUTATED, THE GENE CAN CAUSE NORMAL CELLS TO BECOME CANCEROUS AND GROW UNCONTROLLABLY. TUMORS WITH KRAS MUTATIONS HAVE BEEN SHOWN TO BE UNRESPONSIVE TO CERTAIN TYPES OF LUNG CANCER TREATMENT. THE INVESTIGATIONAL DRUG IS DESIGNED TO STOP THE GROWTH OF TUMOR CELLS WITH THE KRAS G12C MUTATION, WHICH COULD DESTROY ONLY CANCER CELLS AND PRESERVE NORMAL CELLS. THIS TRIAL WILL EXAMINE THE TRIAL MEDICATION TO TEST: WHAT SIDE EFFECTS THE TRIAL MEDICATION MAY CAUSE (REFERRED TO AS "SAFETY"); HOW THE TRIAL MEDICATION IS HANDLED BY THE BODY (REFERRED TO AS "TOLERABILITY"); HOW THE TRIAL MEDICATION WORKS (REFERRED TO AS "EFFICACY"); AND HOW THE TRIAL MEDICATION IS ABSORBED, DISTRIBUTED AND EXCRETED BY THE BODY (REFERRED TO AS "PHARMACOKINETICS" OR "PK").