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A PHASE II TRIAL OF ADDITION OF RANPIRNASE(ONCONASE®) TO PEMETREXED PLUS CARBOPLATIN IN PATIENTS WITH NON-SQUAMOUS NON-SMALL CELL LUNG CANCER


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

A PHASE II TRIAL OF ADDITION OF RANPIRNASE(ONCONASE®) TO PEMETREXED PLUS CARBOPLATIN IN PATIENTS WITH NON-SQUAMOUS NON-SMALL CELL LUNG CANCER


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Outcome Description:

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

Outcome Time Frame:

4 or more months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

P30-800

NCT ID:

NCT01184287

Start Date:

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non Small Cell Lung Cancer, NSCLC, Lung Cancer
  • Previously untreated Non-Squamous, Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Tower Cancer Research Foundation Beverly Hills, California  90211
Northern Utah Associates Ogden, Utah  84403
Van Andel Research Institute Grand Rapids, Michigan  49503
Sletten Cancer Specialists Great Falls, Montana  59405
The Cancer Institute at NYU Langone Medical Center New York, New York  10016
Tri-county Hematology-Oncology Associates, Inc Canton, Ohio  44718