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

A Phase II Trial of Addition of Ranpirnase(ONCONASE®) to Permetrexed Plus Carboplatin in Patientes With Non-Squamous Non-Small Cell Lung Cancer

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01184287

Enrollment

Registered

2010-08-18

Start date

Unknown

Completion date

Unknown

Last updated

2015-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer, NSCLC, Lung Cancer, Previously untreated Non-Squamous, Non-Small Cell Lung Cancer

Brief summary

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.

Interventions

DRUGRanpirnase

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Response	4 or more months	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

Secondary

Measure	Time frame	Description
Progression Free Survival (PFS)	2 years	To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy
Survival	2 years	To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026