NCT05815173

Ladarixin With Sotorasib in Advanced NSCLC

Phase I/II Study of Ladarixin and Sotorasib in Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

Interventions

Type	Name	Description
DRUG	Sotorasib	Sotorasib administered at the approved dose of 960mg PO once daily over 21-day treatment cycles.
DRUG	Ladarixin	Ladarixin dose will be escalated as follows in Phase I: 3 patients will receive a starting dose of 200mg. If 2 or more patients experience a DLT at the lowest dose, the study will stop. If 0 out of 3 patients experience a DLT within 28 days, the next 3 patients will receive 300mg. If 1 out of 3 patients experiences a DLT, 3 more patients will be added to the 200 mg dose. If no more patients experience a DLT at 200mg, the next 3 patients will receive 300mg. If 2 of 6 patients receiving 200mg experience a DLT, the study will stop. If 2 or more patients experience DLTs, the maximum tolerated dose (MTD) will be the previous dose level. The same process will be repeated at each dose level. There will be 6 patients enrolled at MTD level for a maximum of 12 patients in the phase I cohort. Ladarixin will be administered as a twice-daily dose over a 21 day treatment cycle. In Phase II, ladarixin will be administered twice-daily at the recommended phase II dose over 21-day cycles.

Timeline

• Start date: 2023-08-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2023-04-18
• Last updated: 2025-12-30

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study