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Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

Primary Purpose

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

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
talabostat
pemetrexed
Sponsored by
Point Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Marshall Schreeder, MD
  • Hematology Oncology Associates
  • Heritage Physician Group-Oncology
  • Raul R. Mena, MD
  • Pacific Coast Hematology / Oncology Medical Group, Inc.
  • Robert A. Moss, MD, FACP, Inc.
  • Antelope Valley Cancer Center
  • Warren Paroly, MD
  • Southwest Cancer Care Medical Group
  • Mile High Oncology
  • Medical Specialists of Fairfield
  • Northwestern Connecticut Oncology Hematology Associates, LLP
  • Lucio Gordan, MD
  • Cancer and Blood Disease Center
  • Ocala Oncology Center
  • Cancer Center of Florida
  • Northeast Georgia Cancer Care, LLC
  • North Idaho Cancer Center
  • Hematology Oncology Associates of Illinois
  • Joliet Oncology-Hematology Associates
  • American Health Network of Indiana--Hematology/Oncology
  • Arnett Cancer Center
  • Northern Indiana Oncology Associates
  • Associated Physicians and Surgeons, LLC
  • HUX Cancer Center/Union Hospital
  • Kansas City Cancer Center, LLC
  • Kentucky Cancer Clinic
  • Mercy Medical Center
  • Chesapeake Oncology Hematology Associates (Tate Center)
  • Carroll County Cancer Center
  • Fallon Clinic, Inc. at Worcester Medical Center
  • Michael McKenzie, DO
  • Youssef Hanna, MD
  • Cancer and Transplant Consultants, PLC
  • Cancer Care Associates
  • Cancer Care Associates, PC
  • Hematology Oncology Consultants
  • Jeffrey H. Margolis, MD
  • William Beaumont Hospital
  • Dr. Folbe, MD/PC
  • William Beaumont Hospital
  • Minnesota Oncology Hematology, PA
  • Minnesota Oncology Hematology, PA
  • St. Joseph Oncology, Inc.
  • Comprehensive Cancer Centers of Nevada
  • VA Sierra Nevada Health Care System
  • Hunterdon Regional Cancer Center
  • Monmouth Medical Center
  • Hematology Oncology Associates, SJ, PA
  • Capital Health System
  • Mercer Bucks Oncology/Hematology
  • New York Oncology Hematology, PC
  • Northwestern Carolina Oncology & Hematology, PA
  • Eugene Paschold, MD
  • Piedmont Hematology Oncology / Winston-Salem
  • Oncology/Hematology Care, Inc.
  • Dayton Oncology & Hematology, PA
  • Cancer Care Associates
  • Cancer Care Associates
  • Satish A. Shah, MD
  • Medical Oncology Associates of Wyoming Valley, PC
  • Hematology-Oncology Group, PC
  • St. Mary Medical Center--Research Center
  • Paoli Hospital
  • Rittenhouse Hematology Oncology Associates
  • Pottstown Memorial Medical Center
  • Bux-Mont Oncology-Hematology
  • Grandview Hospital
  • Cancer Care Institute of Carolina
  • Charleston Hematology Oncology, PA
  • Palmetto Hematology Oncology PC
  • Associates in Oncology and Hematology
  • McLeod Cancer and Blood Center
  • University of Tennessee
  • Texas Cancer Center
  • Texas Oncology Cancer Center
  • Texas Cancer Center (Dallas Southwest)
  • Mary Crowley Medical Research Center
  • Texas Cancer Center / Denton
  • El Paso Cancer Treatment Center--East
  • Texas Oncology, PA
  • Texas Oncology, PA
  • US Oncology Research and Clinical Pharmacy
  • Joe Arrington Cancer Research and Treatment Center
  • Texas Oncology, PA
  • Texas Oncology, PA / Allison Cancer Center
  • West Texas Cancer Center
  • Paris Regional Cancer Center
  • Texas Oncology Cancer Center--Sugar Land
  • Tyler Cancer Center
  • Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC
  • Fairfax Northern Virginia Hematology / Oncology, PC
  • Virginia Oncology Associates
  • Virginia Physicians, Inc.
  • Oncology & Hematology Associates of Southwest Virginia
  • Luke Walker, MD
  • Cascade Cancer Center
  • Puget Sound Cancer Centers
  • Cancer Care Northwest
  • Northwest Cancer Specialists, PC
  • Medical Consultants, Ltd.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 9, 2006
Last Updated
June 7, 2007
Sponsor
Point Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00290017
Brief Title
Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Terminated
Why Stopped
FDA Hold May 2007
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Point Therapeutics

4. Oversight

5. Study Description

Brief Summary
This Phase 3 study will compare the efficacy of talabostat plus pemetrexed to pemetrexed plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
talabostat
Intervention Type
Drug
Intervention Name(s)
pemetrexed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Marshall Schreeder, MD
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Hematology Oncology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Heritage Physician Group-Oncology
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Raul R. Mena, MD
City
Burbank
State/Province
California
ZIP/Postal Code
91505-4866
Country
United States
Facility Name
Pacific Coast Hematology / Oncology Medical Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Robert A. Moss, MD, FACP, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Antelope Valley Cancer Center
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Warren Paroly, MD
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Southwest Cancer Care Medical Group
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Mile High Oncology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Medical Specialists of Fairfield
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Northwestern Connecticut Oncology Hematology Associates, LLP
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Lucio Gordan, MD
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Cancer and Blood Disease Center
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Cancer Center of Florida
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Northeast Georgia Cancer Care, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
North Idaho Cancer Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Hematology Oncology Associates of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Joliet Oncology-Hematology Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
American Health Network of Indiana--Hematology/Oncology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Arnett Cancer Center
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
08822
Country
United States
Facility Name
Northern Indiana Oncology Associates
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Associated Physicians and Surgeons, LLC
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47804-4080
Country
United States
Facility Name
HUX Cancer Center/Union Hospital
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47804-4080
Country
United States
Facility Name
Kansas City Cancer Center, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Chesapeake Oncology Hematology Associates (Tate Center)
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Carroll County Cancer Center
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Facility Name
Fallon Clinic, Inc. at Worcester Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Michael McKenzie, DO
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Youssef Hanna, MD
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Cancer and Transplant Consultants, PLC
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Cancer Care Associates
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Cancer Care Associates, PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Hematology Oncology Consultants
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Jeffrey H. Margolis, MD
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Dr. Folbe, MD/PC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
William Beaumont Hospital
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Minnesota Oncology Hematology, PA
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Minnesota Oncology Hematology, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
St. Joseph Oncology, Inc.
City
St. Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
VA Sierra Nevada Health Care System
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Hunterdon Regional Cancer Center
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
Hematology Oncology Associates, SJ, PA
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Capital Health System
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08618
Country
United States
Facility Name
Mercer Bucks Oncology/Hematology
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08618
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Northwestern Carolina Oncology & Hematology, PA
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Eugene Paschold, MD
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27013
Country
United States
Facility Name
Piedmont Hematology Oncology / Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Oncology/Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Dayton Oncology & Hematology, PA
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Cancer Care Associates
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Cancer Care Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Satish A. Shah, MD
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Medical Oncology Associates of Wyoming Valley, PC
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Hematology-Oncology Group, PC
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
St. Mary Medical Center--Research Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Paoli Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Rittenhouse Hematology Oncology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Pottstown Memorial Medical Center
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Bux-Mont Oncology-Hematology
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
Grandview Hospital
City
Sellersville
State/Province
Pennsylvania
Country
United States
Facility Name
Cancer Care Institute of Carolina
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29801
Country
United States
Facility Name
Charleston Hematology Oncology, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Palmetto Hematology Oncology PC
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303-3041
Country
United States
Facility Name
Associates in Oncology and Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
McLeod Cancer and Blood Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Texas Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Cancer Center (Dallas Southwest)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Cancer Center / Denton
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
El Paso Cancer Treatment Center--East
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Facility Name
Texas Oncology, PA
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Facility Name
Texas Oncology, PA
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
US Oncology Research and Clinical Pharmacy
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Texas Oncology, PA
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Texas Oncology, PA / Allison Cancer Center
City
Midland
State/Province
Texas
ZIP/Postal Code
79701-5946
Country
United States
Facility Name
West Texas Cancer Center
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
Paris Regional Cancer Center
City
Paris
State/Province
Texas
ZIP/Postal Code
75460-5004
Country
United States
Facility Name
Texas Oncology Cancer Center--Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
Fairfax Northern Virginia Hematology / Oncology, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Physicians, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Oncology & Hematology Associates of Southwest Virginia
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Luke Walker, MD
City
Everett
State/Province
Washington
ZIP/Postal Code
98206
Country
United States
Facility Name
Cascade Cancer Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034-3013
Country
United States
Facility Name
Puget Sound Cancer Centers
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Medical Consultants, Ltd.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

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