Carcinoma, Non-Small-Cell Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary
Conditions
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.
Interventions
DRUGtalabostat
DRUGpemetrexed
Sponsors
Point Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed