RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Sotorasib for Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

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).

Official registry: https://clinicaltrials.gov/study/NCT05815173 · NYU Langone Health · enrollment listed as 40

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Sotorasib, or Ladarixin. The registry lists allocation as na. 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).

They plan to enroll about 40 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Sotorasib, Ladarixin

Primary outcome (registry wording): Incidence of Dose-Limiting Toxicities (DLTs) during 1st Treatment Cycle among Phase I Participants

Who it is for (from inclusion criteria)

Ages 18 Years to 100 Years
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 whose laboratory data at Screening meet the following criteria:

Who the registry excludes

History (≤1 years) or presence of hematological malignancies except stable CLL
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 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

Public study contact (from the registry)

Salman Punekar, MD

212 731 6228

Salman.punekar@nyulangone.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

NYU Langone Health — Garden City, New York (recruiting)
NYU Langone Health — Mineola, New York (recruiting)
NYU Langone Health — New Hyde Park, New York (recruiting)
NYU Langone Health — New York, New York (recruiting)

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FAQ about this NCT record

Is NCT05815173 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05815173?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05815173?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary