A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer

Tamir Biotechnology, Inc.

Overview

The purpose of the trial is to determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Non-Small Cell Lung Cancer

Interventions

RanpirnaseDRUG

Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age greater than 18 years * ECOG less than 2 * Estimated survival of greater than 12 weeks Exclusion Criteria: * Prior systemic chemotherapy for locally advanced or metastatic NSCLC * Use of any investigational agent within 28 days prior to registration * Known hypersensitivity to any of the study drugs * Brain metastases or leptomeningeal disease * History of prior malignancy within the past three years

Locations (6)

Tower Cancer Research Foundation

Beverly Hills, California, United States

Van Andel Research Institute

Grand Rapids, Michigan, United States

Sletten Cancer Specialists

Great Falls, Montana, United States

The Cancer Institute at NYU Langone Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Response

To determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy

Time frame: 4 or more months

Secondary Outcomes

Progression Free Survival (PFS)

To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy

Time frame: 2 years

Survival

To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.