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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: talabostat
* Drug: pemetrexed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: talabostat|nan|
|Drug: pemetrexed|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |