Ladarixin With Sotorasib in Advanced NSCLC - Phase II
Part of paid clinical trials in Garden City, New York.
- Sponsor
- NYU Langone Health
- Study ID
- NCT05815186
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sotorasib — DRUGSotorasib administered at the approved dose of 960mg PO once daily over 21-day treatment cycles
- Ladarixin — DRUGLadarixin administered twice-daily at the recommended phase II dose (RP2D) (determined in the phase I portion of this trial) over 21-day treatment cycles.
Study Details
Study record has been combined with NCT05815173. See NCT05815173 for summary.
Key Dates
- Start date
- Apr 30, 2024
- Status verified
- Mar 2024
- Primary completion
- Apr 30, 2025
- Completion
- Apr 30, 2026
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Advanced NSCLC PatientsPatients with KRASG12C mutant NSCLC will receive ladarixin and sotorasib in combination.
Primary Outcome Measure
Progression Free Survival (PFS) [ Time Frame: Up to End of Survival Follow-Up (Up to Month 36) ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYU Langone Health | Garden City | New York | 11530 | - |
| NYU Langone Health | Mineola | New York | 11501 | - |
| NYU Langone Health | New Hyde Park | New York | 11042 | - |
| NYU Langone Health | New York | New York | 10010 | - |
| NYU Langone Health | New York | New York | 10016 | - |
| NYU Langone Health | New York | New York | 10017 | - |
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