Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

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 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.

Ladarixin

Salman Punekar, MD

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).

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).

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)

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.

DLTs are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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