Non Small Cell Lung Cancer
Conditions
Interventions
Trade Name: Alimta
Product Name: Alimta 500mg powder for infusion
Product Code: LY321514
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: pemetrexed
Current Sponsor code: LY231514
Conce
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Men or women, 18 years of age or older · NSCLC has been histologically or cytologically confirmed · Has relapsed or refractory locally advanced (Stage IIIb) or metastatic (Stage IV) NSCLC (see Attachment 3 for tumor nodule metastasis [TNM] staging) · Failed one prior line of systemic antineoplastic therapy for Stage IIIb/IV NSCLC (one additional prior line allowed if given as neoadjuvant, or adjuvant therapy to tumor resection) · Subject must have documented PD since previous systemic antineoplastic therapy · Has measurable disease per RECIST criteria (Attachment 4) · Has an ECOG performance status score of 0 or 1 (Attachment 5) · Has a life expectancy greater than 3 months · Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening · Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to and able to comply with the protocol requirements and participate in the study before any study-related procedure not part of normal medical care is conducted. · In countries where health authorities have approved the pharmacogenomic and protein testing, subjects (or their legally acceptable representatives) must have signed an informed consent for testing indicating, that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for testing described in Section 9.4, but optional for future research. 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
Exclusion criteria
Exclusion criteria: · Has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE Version 3.0) · Previous treatment with VELCADE or Alimta · Has received 2 or more prior lines of antineoplastic therapies for Stage IIIb/IV NSCLC · Any prior systemic antineoplastic therapy for NSCLC (i.e., prior chemotherapy, radiation therapy, prior monoclonal antibodies or any investigational drug or any major surgery) within 4 weeks before randomization · Has had significant weight loss (documented =10% body weight in the 6 weeks before randomization) · Inadequate organ function at the screening visit as defined by the following laboratory values: Platelet count =100 x 10E9/L Hemoglobin =8.0 g/dL (80 g/L) Absolute neutrophil count (ANC) =1.5 x 10E9/L AST =3 times the upper limit of the normal range (ULN) or >5 times the ULN for subjects with liver metastases ALT =3 times ULN Calculated creatinine clearance =45 mL/min Total bilirubin =1.5 times ULN · Myocardial infarction within 6 months before randomization or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. (Attachment 6) · Central nervous system metastasis or brain metastases that have not been completely resected or completely eliminated by radiation therapy and/or chemotherapy, or clinical or radiographic evidence that they have recurred. Subjects with a history of brain metastases are required to have had a brain computed tomography (CT) or magnetic resonance imaging (MRI) scan conducted within 1 month of enrollment to verify the continuing absence of brain metastases. · Uncontrolled pleural effusion (defined as more than 2 pleuracentesis within 4 weeks of the randomization) · Active systemic infection requiring treatment · Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long-acting agents, such as piroxicam) · Unable or unwilling to take corticosteroids · Other malignancy within the past 5 years. Exceptions for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix · History of allergic reaction attributable to compounds containing boron or mannitol · Is pregnant or breast-feeding · Currently enrolled in another clinical research study or has received an investigational agent for any reason within 4 weeks before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Establish the objective tumor response rate (CR + PR) following treatment with VELCADE plus Alimta or Alimta alone or VELCADE alone in subjects with locally advanced or metastatic NSCLC who have failed prior antineoplastic therapy for Stage IIIb/IV NSCLC.;Secondary Objective: · Disease control rates including Complete Response (CR), Partial Response (PR) and Stable Disease (SD) · Time to Tumor Progression (TTP), time to response, Duration of Response (DoR), and duration of disease control · progression-free survival (PFS), overall survival, and 6- and 12-month survival rates · Safety will be evaluated throughout the study by assessment of adverse events, changes in physical examinations, 11-item module Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx) scores, Eastern Cooperative Oncology Group (ECOG) performance scores, vital signs, and clinical laboratory findings. ;Primary end point(s): Objective response rate has been chosen as primary endpoint, as this is an exploratory Phase 2 study to determine if Alimta plus VELCADE has any antitumor activity in the selected subject population. Response rate has been commonly used in clinical research of this context and responses were previously observed with a different VELCADE treatment schedule in NSCLC subjects (see also Section 9.3). | — |
Countries
Germany, Italy
Outcome results
None listed