A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care versus Best Supportive Care Immediately Following Induction Treatment with Pemetrexed + Cisplatin for Advanced Non-Squamous Non Small Cell Lung Cancer
- Conditions
- Advanced Non-Squamous Non Small Cell Lung cancerMedDRA version: 9.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVMedDRA version: 9.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIB
- Registration Number
- EUCTR2008-002155-24-NL
- Lead Sponsor
- Eli Lilly and Company Limited, UK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 570
[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 <25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study enrollment. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
[6]At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria (at least 10 mm in longest diameter by spiral computerized tomography [CT] scan, or at least 20 mm by standard techniques). Positron emission tomography (PET) scans and ultrasounds may not be used for tumor measurements.
[7]Estimated life expectancy of at least 12 weeks.
[8]Patient compliance and geographic proximity that allow adequate follow up.
[9]Adequate organ function, including the following:
•Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) > or = 1.5 x 109/L, platelets > or = 100 x 109/L, and hemoglobin > or = 9 g/dL.
•Hepatic: bilirubin < or = 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) < or = 3.0 x ULN (AP, AST, and ALT < or = 5 x ULN is acceptable if liver has tumor involvement).
•Renal: calculated creatinine clearance (CrCl) > 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 <1%) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment and must not be breast-feeding.
For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
[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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method