Phase I/II Study of Ladarixin and Sotorasib in Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)
NYU Langone Health
Summary
This is a phase I/II, open-label, study of twice-daily oral ladarixin with sotorasib in participants with advanced KRASG12C mutant non-small cell lung cancer (NSCLC).
Description
This study will enroll patients with KRASG12C mutant NSCLC not previously treated with KRASG12C inhibitors. Patients in this study will receive ladarixin and sotorasib. The primary objective of the Phase I portion is to define a recommended phase II dose (RP2D) of ladarixin when combined with sotorasib. The primary objective of the Phase II portion is to evaluate progression free survival (PFS).
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses. * Participant must be ≥18 years of age at the time of signature of the informed consent form (ICF). * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous). * Patients with metastatic or locally advanced NSCLC who are not candidates for curative surgery or curative radiation. * Do not have an epidermal gr…