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A Phase 3, Randomized, Double-Blind, Multicenter Study of Talabostat and Pemetrexed vs. Pemetrexed and Placebo in Patients With Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

Phase 3
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary

Thank you

Trial Information

A Phase 3, Randomized, Double-Blind, Multicenter Study of Talabostat and Pemetrexed vs. Pemetrexed and Placebo in Patients With Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

Inclusion Criteria:

- Men or women age ≥18 years

- Histologically or cytologically confirmed NSCLC (Recurrent, locally advanced or
metastatic, inoperable NSCLC [Stage IIIB/IV]. Patients with Stage IIIB NSCLC must
have a cytologically documented pleural effusion.)

- Failed or relapsed after receiving a platinum-containing chemotherapy regimen as
first-line therapy for advanced NSCLC

- Measurable disease on computerized tomography (CT) scan

- ECOG Performance Status of 0 or 1

- Expected survival ≥12 weeks

- Provide written informed consent

Exclusion Criteria:

- More than 2 prior chemotherapy regimens

- Progression of disease on prior pemetrexed treatment

- Brain metastases (exception: patients who had a resection and/or completed a course
of cranial irradiation, have no worsening CNS symptoms, and have discontinued all
corticosteroids for that indication for at least 1 month)

- Serum creatinine ≥2.0mg/dL or creatinine clearance <45mL/min

- Absolute neutrophil count <1500/μL or platelets <100,000/μL

- Any malignancy within 5 years immediately prior to the first dose of study medication
(exception: basal cell or non-metastatic squamous cell carcinoma of the skin, and
carcinoma in-situ of the cervix)

- Any comorbidity or condition which, in the opinion of the investigator, may interfere
with the assessments and procedures of this protocol

- Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or
investigational medication for NSCLC. Patients must have recovered from all of the
side effects of treatment.

- Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must
agree to use a barrier method of contraception during treatment.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Neoplasms, Lung
  • Neoplasms, Pulmonary
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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Virginia Oncology Associates Newport News, Virginia  23606
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Ocala Oncology Center Ocala, Florida  34474
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Tyler Cancer Center Tyler, Texas  75702
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Cancer Care Associates Tulsa, Oklahoma  74136
Cascade Cancer Center Kirkland, Washington  98034-3013
St. Joseph Oncology, Inc. Saint Joseph, Missouri  64506
Associates in Oncology and Hematology Chattanooga, Tennessee  37404
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Hematology Oncology Associates of Illinois Skokie, Illinois  60077
Northwestern Connecticut Oncology Hematology Associates, LLP Torrington, Connecticut  06790
Texas Oncology, PA Dallas, Texas  75246-2006
Mercy Medical Center Baltimore, Maryland  21202
Medical Oncology Associates of Wyoming Valley, PC Kingston, Pennsylvania  18704
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Mile High Oncology Denver, Colorado  80210
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Hematology Oncology Associates Phoenix, Arizona  85012
Cancer Center of Florida Ocoee, Florida  34761
Texas Cancer Center Abilene, Texas  79606
Texas Oncology Cancer Center Austin, Texas  78731
Cancer Care Institute of Carolina Aiken, South Carolina  29801
VA Sierra Nevada Health Care System Reno, Nevada  89502
Oncology & Hematology Associates of Southwest Virginia Roanoke, Virginia  24101
Pottstown Memorial Medical Center Pottstown, Pennsylvania  19464
Minnesota Oncology Hematology, PA Minneapolis, Minnesota  55404
New York Oncology Hematology, PC Albany, New York  12208
Puget Sound Cancer Centers Edmonds, Washington  98026
Northwest Cancer Specialists, PC Vancouver, Washington  98684
Northern Indiana Oncology Associates South Bend, Indiana  46617
Paris Regional Cancer Center Paris, Texas  75460
Charleston Hematology Oncology, PA Charleston, South Carolina  29403
Antelope Valley Cancer Center Lancaster, California  93534
Northwestern Carolina Oncology & Hematology, PA Hickory, North Carolina  28602
Cancer and Blood Disease Center Lecanto, Florida  34461
McLeod Cancer and Blood Center Johnson City, Tennessee  37604
Dayton Oncology & Hematology, PA Kettering, Ohio  45409
Medical Specialists of Fairfield Fairfield, Connecticut  
University of Tennessee Memphis, Tennessee  38163
Marshall Schreeder, MD Huntsville, Alabama  35801
Robert A. Moss, MD, FACP, Inc. Fountain Valley, California  92708
Warren Paroly, MD Oceanside, California  92056
Southwest Cancer Care Medical Group Poway, California  92064-2527
Lucio Gordan, MD Gainesville, Florida  32605
Chesapeake Oncology Hematology Associates (Tate Center) Glen Burnie, Maryland  21061
Michael McKenzie, DO Clinton Township, Michigan  48038
Youssef Hanna, MD Port Huron, Michigan  48060
Cancer and Transplant Consultants, PLC Rochester Hills, Michigan  48307
Cancer Care Associates Rochester Hills, Michigan  48307
Cancer Care Associates, PC Royal Oak, Michigan  48073
Hematology Oncology Consultants Royal Oak, Michigan  48073
Jeffrey H. Margolis, MD Royal Oak, Michigan  48073
Rittenhouse Hematology Oncology Associates Philadelphia, Pennsylvania  19146
Texas Cancer Center (Dallas Southwest) Dallas, Texas  75237
Texas Cancer Center / Denton Denton, Texas  76210
US Oncology Research and Clinical Pharmacy Ft. Worth, Texas  76177
Texas Oncology Cancer Center--Sugar Land Sugar Land, Texas  77479
Heritage Physician Group—Oncology Hot Springs, Arkansas  71913
Raul R. Mena, MD Burbank, California  91505-4866
Pacific Coast Hematology / Oncology Medical Group, Inc. Fountain Valley, California  92708
Joliet Oncology-Hematology Associates Joliet, Illinois  60435
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Arnett Cancer Center Lafayette, Indiana  08822
Associated Physicians and Surgeons, LLC Terre Haute, Indiana  47804-4080
HUX Cancer Center/Union Hospital Terre Haute, Indiana  47804-4080
Kansas City Cancer Center, LLC Overland Park, Kansas  66210
Carroll County Cancer Center Westminster, Maryland  21157
Fallon Clinic, Inc. at Worcester Medical Center Worcester, Massachusetts  01608
Dr. Folbe, MD/PC Troy, Michigan  48085
Hematology Oncology Associates, SJ, PA Mount Holly, New Jersey  08060
Mercer Bucks Oncology/Hematology Trenton, New Jersey  08618
Capital Health System Trenton, New Jersey  08618
Eugene Paschold, MD Winston Salem, North Carolina  27013
Piedmont Hematology Oncology / Winston-Salem Winston-Salem, North Carolina  27103
Satish A. Shah, MD Gettysburg, Pennsylvania  17325
St. Mary Medical Center--Research Center Langhorne, Pennsylvania  19047
Hematology-Oncology Group, PC Langhorne, Pennsylvania  19047
Paoli Hospital Paoli, Pennsylvania  19301
Grandview Hospital Sellersville, Pennsylvania  
Bux-Mont Oncology-Hematology Sellersville, Pennsylvania  18960
Palmetto Hematology Oncology PC Spartanburg, South Carolina  29303-3041
El Paso Cancer Treatment Center--East El Paso, Texas  79915
Texas Oncology, PA / Allison Cancer Center Midland, Texas  79701-5946
Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC Abingdon, Virginia  24211
Fairfax Northern Virginia Hematology / Oncology, PC Fairfax, Virginia  22031
Virginia Physicians, Inc. Richmond, Virginia  23229
Luke Walker, MD Everett, Washington  98206