Non Small Cell Lung Cancer ( NSCLC) MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
Conditions
Interventions
Product Name: LY2275796 Sodium
Product Code: LY2275796
Pharmaceutical Form: Solution for infusion
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Histologically or cytologically confirmed diagnosis of NSCLC. [2] Stage IIIB (N3 and/or pleural or pericardial effusion) or IV disease that is not amenable to either surgery of curative intent or radiation therapy. Refer to Protocol Attachment JKAH.4., American Joint Committee on Cancer Staging Criteria for Lung Cancer (Fleming et al. 1997). [3] All of the following if patient has had prior radiation therapy: •Lesion(s) used for determination of response were not previously irradiated or have increased in size since the completion of radiotherapy. •Patient has fully recovered from any toxicity of the radiotherapy. •Radiotherapy was completed at least 2 weeks prior to enrollment. [4] Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan, OR nonmeasurable disease (Part 1 only), defined according to RECIST (refer to Protocol Attachment JKAH.5.) [5] Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (refer to Protocol Attachment JKAH.6). [6] Have an estimated life expectancy of at least 12 weeks. [7] Adequate organ function, including the following: Hematologic: Absolute neutrophil count (ANC) 1.5 109/L, platelets ?100 ? 109/L, and hemoglobin ?9 g/dL (?5.6 mmol/L). Patients may receive erythrocyte transfusion to achieve this hemoglobin level at the discretion of the investigator. Hepatic: Bilirubin ?1.5 times the upper limit of normal (ULN), alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ?3.0 ? ULN. Renal: Calculated creatinine clearance ?60 mL/min per Cockcroft and Gault formula (refer to Protocol Attachment JKAH.7) (Cockcroft and Gault 1976). [8] For Part 1: Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy. [9] Patient compliance and geographic proximity (investigator’s discretion) that allows adequate follow-up. [10] Must sign an informed consent document (or legal representative has given informed consent). [11] Males or females of at least 18 years of age. [12] Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must test negative for pregnancy within 7 days prior to or at the time of enrollment based on a serum pregnancy test. Both males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and his or her health care team, during the study and for 6 months following the last dose of study treatment. 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: Patients will be excluded from the study if they meet any of the following 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] Part 1: More than 2 prior chemotherapy or biological therapy (approved or experimental) for NSCLC, not including adjuvant and neoadjuvant treatment. Part 2: Prior chemotherapy or biological therapy (approved or experimental) for NSCLC, including adjuvant and neo-adjuvant treatment. [15] Inability to undergo hydration/diuresis (per investigator’s discretion) for cisplatin administration. [16] Have documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 4 weeks before enrollment. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients. [17] Have active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the investigator). [18] Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment. [19] Have bleeding diatheses. [20] Peripheral neuropathy, CTCAE ?Grade 2 (Cancer Therapy Evaluation Program 2003). [21] Patients eligible for combined modality therapy as defined by the combination of chemotherapy, radiation therapy, and/or surgery. [22] Have known hypersensitivity to oligonucleotides or any component of the formulation. [23] Concurrent treatment with other anti-cancer drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Study consists of two parts. The primary objective of Part 1 of the study is to determine a safe dose of LY2275796 in combination with gemcitabine and cisplatin for Part 2. The primary objective of Part 2 of the study is to determine whether the progression-free-survival in patients with advanced (Stage IIIB or IV) NSCLC can be improved by combining LY2275796 with gemcitabine and cisplatin. ;Secondary Objective: The secondary objectives of this study are: •To characterize the safety and PK parameters for the combination of LY2275796, gemcitabine, and cisplatin. •To determine the time-to-event efficacy measures. 1. Overall survival 2. Duration of response for responding patients 3. Time-to-response for responding patients •To evaluate the tumor response rate and change in tumor ;Primary end point(s): Safety and Progression Free Survival. | — |
Countries
France
Outcome results
None listed