Advanced Non-Squamous Non Small Cell Lung cancer MedDRA version: 9.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV MedDRA version: 9.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB
Conditions
Interventions
Trade Name: Alimta
Pharmaceutical Form: Powder for concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous
Sponsors
Eli Lilly and Company Limited, UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Histological or cytological diagnosis of NSCLC defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted). [2] Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or Stage IV prior to induction therapy, as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy [3] ECOG performance status (PS) of 0 or 1 [4] Patients must have had no prior systemic chemotherapy for lung cancer. [5] Previous radiation therapy is allowed to or = 1.5 x 109/L, platelets > or = 100 x 109/L, and hemoglobin > or = 9 g/dL. • Hepatic: bilirubin or = 45 mL/min based on the original weight based Cockcroft and Gault formula [10] Patients must sign an informed consent document [11] Patients must be at least 18 years of age [12] For women: Must be surgically sterile, post-menopausal, or compliant with a highly reliable contraceptive method (failure rate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [13] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [14] Have previously completed or withdrawn from this study or any other study investigating pemetrexed. [15] Have a serious concomitant systemic disorder (for example, active infection including human immunodeficiency virus) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol. [16] Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV [17] Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low-grade (Gleason score < or = 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously. [18] Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy). A screening CT scan or magnetic resonance imaging (MRI) before enrollment in the absence of a clinical suspicion of brain metastases is not required [19] Are receiving concurrent administration of any other antitumor therapy. [20] Have clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. [21] Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination. [22] Have received prior systemic anticancer therapy for lung cancer (including adjuvant early-stage treatment for NSCLC). [23] Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose < or =1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). [24] Are unable or unwilling to take folic acid, vitamin B12 supplementation, or corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare maintenance therapy with pemetrexed plus best supportive care (BSC) versus placebo plus BSC, in terms of objective progression-free survival (PFS) time in patients with Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV non squamous NSCLC whose disease has not progressed during 4 cycles of pemetrexed + cisplatin induction chemotherapy.;Secondary Objective: Secondary objectives of this study are to compare the following between randomized treatment arms: • Time-to-event efficacy endpoint:overall survival time • Objective tumor response rate • Patient-reported outcomes using the EuroQol 5-dimensional scale • Resource utilization • Toxicity ;Primary end point(s): Objective Progression-Free Survival Time is defined as the time from the date of randomization to the first of date of objectively determined progressive disease or death from any cause. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation chemotherapy. | — |
Countries
Belgium, Finland, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed