Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Sotorasib

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Patients with KRASG12C mutant NSCLC will receive ladarixin and sotorasib in combination.

Sotorasib administered at the approved dose of 960mg PO once daily over 21-day treatment cycles

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.

Ladarixin

Salman Punekar, MD

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

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)

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: salman.punekar@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

PFS is the amount of time (months) from initial treatment to disease progression or death from any cause.

Number of participants whose most severe treatment-related adverse event was rated Grade 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, where Grade 5 = death related to adverse event.

Number of participants whose most severe adverse event related to treatment was rated Grade 4 according to CTCAE version 5.0, where Grade 4 = life-threatening consequences; urgent intervention indicated.

Number of participants whose most severe treatment-related adverse event was rated Grade 3 according to CTCAE version 5.0, where Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living (ADL).

Number of participants whose most severe treatment-related adverse event was rated Grade 2 according to CTCAE version 5.0, where Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.

Number of participants whose most severe treatment-related adverse event was rated Grade 1 according to CTCAE version 5.0, where Grade 1 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL.

Percent of participants whose best response is a CR according to RECIST 1.1, where CR = disappearance of all target lesions.

Percent of participants who best response is a PR according to RECIST 1.1, where PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Percent of participants who best response is a CR according to RECIST 1.1, but the response has not been confirmed.

Percent of participants who best response is a PR according to RECIST 1.1, but the response has not been confirmed.

OS is the amount of time (months) from initial treatment to death due to any cause.

Spots Global Cancer Trial Database for Ladarixin With Sotorasib in Advanced NSCLC - Phase II

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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