This is a multicenter, non-randomized, open-label, phase I/II study to evaluate the safety
and tolerability of AMG 510 plus MVASI in subjects with advanced KRAS p.G12C mutant non-small
cell lung cancer (NSCLC) with small, untreated brain metastases.
Each patient is scheduled to receive AMG 510 (KRASG12C inhibitor) in combination with MVASI
(vascular endothelial growth factor [VEGF] inhibitor; bevacizumab biosimilar); both drugs
will be provided by the study:
Continuous once daily (QD) oral dosing (Days 1-21 each cycle) with or without food.
Intravenous (i.v.) infusion every 21 days (i.e. Day 1 of each 21-day cycle).
The study will be conducted in 2 parts. The dose expansion part of the study (Part 2) can
open once the maximum tolerated dose (MTD) and/or a biologically active dose (e.g.
recommended phase 2 dose [RP2D]) using a 3+3 study design has been determined in Part 1.
CNS response will be assessed using RANO-BM criteria, and non-CNS objective response will be
based on Solid Tumor Response Criteria [RECIST v1.1] assessment of overall tumor burden at
baseline versus that detected on subsequent CT/MRI re-scans. This includes a brain MRI on
C2D1 (21 days) and a CT chest/abdomen/pelvis (C/A/P) at 6 weeks, then brain MRI at 15 weeks
and CT C/A/P imaging at 12-16 weeks, and then every 4 cycles (every 12 weeks) while on study.
It is intended that patients will be treated until disease progression or intolerable
toxicity. Patients will be followed for survival for up to 18 months after ending study
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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