Unresectable, metastatic non-small cell lung cancer (NSCLC) MedDRA version: 9.1 Level: LLT Classification code 10059515 Term: Non-small cell lung cancer metastatic
Conditions
Interventions
Product Name: LY573636
Product Code: LY573636
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 519055-63-1
Current Sponsor code: LY573636
Concentration unit: mg milligram(s)
Concentra
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who: [1] Have a histologic and/or cytologic diagnosis of metastatic NSCLC that is unresectable. Patients with unresectable, Stage IIIB disease are also eligible. [2] Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). [3] Are at least 18 years of age. [4] Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale. [5] Have received two previous systemic treatment regimens for metastatic NSCLC, one of which must have been platinum-based. [6] Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia). [7] Have adequate organ function including: • Bone Marrow Reserve: Absolute neutrophil count (ANC) =1.5 x 109/L prior to treatment, platelets =100 x 109/L, and hemoglobin =8 g/dL (transfusions are not allowed to reach 8 g/dL prior to enrollment). • Hepatic: Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who: [12] 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. [13] Have received = 3 previous systemic treatment regimens for metastatic NSCLC. [14] Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. [15] Patients with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator). [16] Patients with a second primary malignancy that could affect compliance with the protocol or interpretation of the results. NOTE: Patients with adequately treated carcinoma of the skin (excluding melanoma) and patients with a prior history of malignancy who have been disease-free for more than 2 years are eligible. [17] Patients with serious preexisting medical conditions (at the investigator’s discretion). [18] Patients actively receiving warfarin (Coumadin®) therapy for treatment of venous thrombosis or other prothrombotic conditions. NOTE: Patients receiving low dose (1 mg daily) warfarin will be allowed in this study. For those patients, more frequent monitoring of PT (INR)/aPTT will be required. [19] Persons who have previously completed or withdrawn from this study or any other study investigating LY573636. [20] Women who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the time-to-progressive disease for patients who have received LY573636 after two prior treatment regimens of systemic therapy for unresectable, metastatic non-small cell lung cancer (NSCLC).;Secondary Objective: • To characterize the progression-free survival distribution • To estimate the objective response rate (complete response [CR] and partial response [PR]) and clinical response rate (CR+PR+stable disease) • To evaluate the pharmacokinetics of LY573636 using a limited sampling methodology in this population • To estimate time-to-event variables, such as overall survival time, duration of overall objective response (up to 1 year), and duration of stable disease (up to 1 year) • To evaluate the safety of LY573636 in this patient population.;Primary end point(s): To estimate time-to-progressive disease and 90% confidence limits for this patient population. | — |
Countries
Germany, Italy
Outcome results
None listed