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Withdrawn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 — DRUG
    Sotorasib administered at the approved dose of 960mg PO once daily over 21-day treatment cycles
  • Ladarixin — DRUG
    Ladarixin 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 Patients
    Patients 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)

FacilityCityStateZIPSite coordinators
NYU Langone HealthGarden CityNew York11530-
NYU Langone HealthMineolaNew York11501-
NYU Langone HealthNew Hyde ParkNew York11042-
NYU Langone HealthNew YorkNew York10010-
NYU Langone HealthNew YorkNew York10016-
NYU Langone HealthNew YorkNew York10017-

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