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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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Cancer Care AssociatesTulsa, Oklahoma  74136
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Pottstown Memorial Medical CenterPottstown, Pennsylvania  19464
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Cancer and Blood Disease CenterLecanto, Florida  34461
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Marshall Schreeder, MDHuntsville, Alabama  35801
Robert A. Moss, MD, FACP, Inc.Fountain Valley, California  92708
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Rittenhouse Hematology Oncology AssociatesPhiladelphia, Pennsylvania  19146
Texas Cancer Center (Dallas Southwest)Dallas, Texas  75237
Texas Cancer Center / DentonDenton, Texas  76210
US Oncology Research and Clinical PharmacyFt. Worth, Texas  76177
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Heritage Physician Group—OncologyHot Springs, Arkansas  71913
Raul R. Mena, MDBurbank, California  91505-4866
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Kansas City Cancer Center, LLCOverland Park, Kansas  66210
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Mercer Bucks Oncology/HematologyTrenton, New Jersey  08618
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Eugene Paschold, MDWinston Salem, North Carolina  27013
Piedmont Hematology Oncology / Winston-SalemWinston-Salem, North Carolina  27103
Satish A. Shah, MDGettysburg, Pennsylvania  17325
St. Mary Medical Center--Research CenterLanghorne, Pennsylvania  19047
Hematology-Oncology Group, PCLanghorne, Pennsylvania  19047
Paoli HospitalPaoli, Pennsylvania  19301
Grandview HospitalSellersville, Pennsylvania  
Bux-Mont Oncology-HematologySellersville, Pennsylvania  18960
Palmetto Hematology Oncology PCSpartanburg, South Carolina  29303-3041
El Paso Cancer Treatment Center--EastEl Paso, Texas  79915
Texas Oncology, PA / Allison Cancer CenterMidland, Texas  79701-5946
Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLCAbingdon, Virginia  24211
Fairfax Northern Virginia Hematology / Oncology, PCFairfax, Virginia  22031
Virginia Physicians, Inc.Richmond, Virginia  23229
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