Locally Advanced or Metastatic Non-Small Cell Lung Cancer MedDRA version: 13.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Survivin ASO.Sodium
Product Code: LY2181308.Sodium
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: LY2181308 sodium
Other descri
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with non-small cell lung cancer with locally or advanced metastatic disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy • Measureable disease as defined by response evaluation criteria in solid tumors (RECIST) • ECOG Performance status of 0 to 1 • Must make available any existing tumor tissue from the primary biopsy • Patients with prior radiation may be eligible if they meet certain criteria • Adequate bone marrow reserve and organ functioning • Women must have a negative pregnancy test and must comply with a highly reliable contraceptive method during and for 6 months after the treatment period. Must not be breastfeeding • Men must comply 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
Exclusion criteria
Exclusion criteria: • Currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. Patients may be permitted to enter treatment before the 30 day waiting period in special circumstances • Pregnant or breastfeeding • Serious concomitant systemic disorders that would compromise the safety of the patient or the patient's ability to complete the study • Second primary malignancy that could affect compliance with the protocol or interpretation of the study results • Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides, or any component of the formulations • Patients with documented central nervous system or brain metastasis at the time of study entry • Pre-existing neuropathy equivalent to a common terminology criteria for adverse events(CTCAE)code greater than or equal to 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel therapy (experimental arm) compared to docetaxel alone (control or standard-of-care arm) in second line Non Small Cell Lung Cancer (NSCLC) patients.;Secondary Objective: - To characterize and compare the quantitative and qualitative toxicities of LY2181308 combined with docetaxel and docetaxel in this patient population - To compare efficacy variables of both therapies including: time to event variables (progression-free survival, overall survival, time to worsening of symptoms, time to objective tumour response, time to documented disease progression), objective tumour response rate, duration of response - To evaluate the PK of LY2181308 and docetaxel alone and when combined - To explore biomarkers relevant to tumour progression and/or survivin expression - To compare changes in the individual item scores, the average symptom burden index (ASBI) and total score of the Lung cancer symptom scale (LCSS);Primary end point(s): Change in tumor size; from baseline to the end of Cycle 2.;Timepoint(s) of evaluation of this end point: Baseline, end of Cycle 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Characterization of toxicities as defined by common terminology criteria for adverse events (CTCAE) coding Progression Free Survival Population Pharmacokinetics,including concentration of LY2181308 and docetaxel Overall Survival Time to worsening of symptoms as defined by Lung Cancer Symptom Score (LCSS) questionnaire Time of Objective tumor response of Partial Response (PR) or Complete Response (CR) Time to documented disease progression Percent of patients having a Partial Response (PR) or a Complete Response (CR) Duration of Response Change from baseline through 30 day follow up in Average Symptom Burden Index (ASBI) Change from baseline through 30 day follow up in Lung Cancer Symptom Scale (LCSS) ;Timepoint(s) of evaluation of this end point: Every cycle, 30 day follow up and long term follow up (every 6 weeks until progression then every 60 days for survival or until study ends) Randomization to the first date of progressive disease or death from any cause Lead in phase, Cycle 1, Cycle 2 then every other Cycle, 30 day follow up visit Randomization to date of death from any cause Baseline to the worsening of symptoms (30 day follow up) Randomization to the date of first response Randomization to the first date of progressive disease Randomization to the first date of progressive disease Time of response to progressive disease Baseline, 30 day follow up Baseline, 30 day follow up | — |
Countries
Belgium, Germany, Italy, Poland, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly & Co.
Outcome results
None listed