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

Tamir Biotechnology

Status and phase: Withdrawn; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Ranpirnase

Study type: Interventional

Funder types: Industry

Identifiers

NCT01184287

P30-800

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

ranpirnase

Experimental group

Description:

All patients who do not progress after two cycles of pemetrexed-carboplatin will receive the study drug, ranpirnase

Treatment:

Drug: Ranpirnase