Ladarixin With Sotorasib in Advanced NSCLC - Phase II

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

NCT05815186•NYU Langone Health

View on ClinicalTrials.gov

Summary

Study record has been combined with NCT05815173. See NCT05815173 for summary.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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 growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) translocation, rearranged during transfection (RET), ROS1 or other actionable molecular alterations that can be treated with FDA approved targeted agents.
•Patients must have documentation of presence of KRASG12C mutation in tumor tissue.
•Patients must have demonstrated progression of disease following treatment with anti-PD (L)-1 with or without platinum-based chemotherapy.
•Participants must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Tumor lesions that have been irradiated ≥4 weeks before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions in the absence of measurable lesions that have not been irradiated.
•Participants whose laboratory data at Screening meet the following criteria:
+12 more criteria

Exclusion Criteria

•History (≤1 years) or presence of hematological malignancies except stable chronic lymphocytic leukemia.
•History (≤1 years) of other cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, ductal carcinoma in situ, prostatic intraepithelial neoplasia, superficial non-invasive bladder tumors, or curatively treated stage I non-melanoma skin cancer.
•Known serious allergy to ladarixin, sotorasib, or excipients (e.g., microcrystalline cellulose).
•History (≤6 months before the start of treatment with the study drugs) of severe autoimmune disease (including ≥ Grade 3 or recurrent Grade 2 immune-related AEs of prior immuno-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \>10 mg/day or equivalent).
•Brain or spinal metastases, except if treated by surgery or surgery plus radiotherapy or radiotherapy alone, with no clinical evidence of progression or hemorrhage for ≤7 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥7 days before the start of treatment with the study drugs.
•History (≤6 months before the start of treatment with the study drugs) of pericarditis (any grade) or pericardial effusion (Grade ≥2).
•History of interstitial lung disease, radiation pneumonitis which required steroid treatment, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or organizing pneumonia.
•Active infection requiring systemic treatment at the start of treatment in this trial. A washout period of 7 days after the last dose of antibiotics prior to first dose of study drug is required.
•History of seropositive status for human immunodeficiency virus (HIV) at any time before the start of treatment as determined by presence of anti-HIV-1 or anti-HIV-2 antibodies.
•\-- Note: Testing for seropositive status during Screening will be at the discretion of the investigator in participants without previously reported results.
+35 more criteria

Locations (6)

NYU Langone Health

Garden City, New York, United States

NYU Langone Health

Mineola, New York, United States

NYU Langone Health

New Hyde Park, New York, United States

NYU Langone Health

New York, New York, United States

NYU Langone Health

New York, New York, United States

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

April 1, 2024

Primary Completion Date

April 1, 2025

Completion Date

April 1, 2026

Last Updated

March 29, 2024

Conditions

Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

Interventions

Sotorasib

DRUG

Ladarixin

DRUG