Extensive Disease Small Cell Lung Cancer MedDRA version: 20.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Have histological or cytological diagnosis of ED-SCLC and received a prior platinum-based regimen. Cohort 1 must have had an objective response to prior platinum-based therapy with subsequent progression >= 90 days after the last dose of platinum. Cohort 2 must either have not had an objective response to prior platinum based therapy or had progression = 1.5x 10^9/L, platelets >= 100 x 10^9/L, Hemoglobin >= 8 g/dL or >=5 mmol Hepatic: direct bilirubin = 50 mL/min/1.73 m^2 8) Men must be sterile or agree to use an effective method of contraception or a highly effective method of contraception during the study and for at least 12 weeks following the last dose of LY2606368 9) Women of childbearing potential must have a negative serum pregnancy test at the baseline visit, have another negative urine pregnancy test within 7 days prior to the first dose of LY2606368, agree to use a highly effective method of contraception during the study and for 12 weeks following the last dose of LY2606368 and not be breast-feeding. 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: 1) Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy) Each line of therapy is preceded by disease progression. Discontinuation of a regimen without progression (for example, due to toxicity) or a switch of an agent within the same drug class (for example, cisplatin to carboplatin) within a regimen to manage toxicity does not define the start of a new line of therapy. Similarly, maintenance therapy (continuation maintenance or switch maintenance) will not be considered a new line of treatment. 2) Have symptomatic central nervous system (CNS) malignancy or metastasis. Asympomatic patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids to treat CNS metastases. CNS metastases should be stable for at least 14 days by clinical assessment, and patients should not have received corticosteroids to treat CNS metastases within 14 days of the first dose of study drug 3) Have a second primary malignancy that in the judgment of the investigator and Lilly may affect the interpretation of results 4) Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study 5) Have previously completed or withdrawn from this study or any other study investigating LY2606368 or a CHK1 inhibitor or have shown hypersensitivity to any of the components of the LY2606368 formulation 6) Have a known serious concomitant systemic disorder (for example, active infection or cardiac disease) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol 7) Have a symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required). If the medical history, symptoms, and/or laboratory values suggest that the patient may have HIV or hepatitis A,B, or C, appropriate assessment should be conducted to determine whether the patient should be excluded 8) Have a serious cardiac condition, such as: • symptomatic congestive heart failure • New York Heart Association Class III/IV heart disease • unstable angina pectoris • symptomatic or poorly controlled cardiac arrhythmia • myocardial infarction within the last 3 months • have a QT interval using Frederica’s correction (QTcF) of >470 msec on more than one screening electrocardiogram (ECG) • a family history of long-QT syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cohort 1: To estimate the Overall Response Rate (ORR) when a dose of 105 mg/m2 LY2606368 every 14 days is administered to patients with ED-SCLC that have platinum-sensitive disease. Cohort 2: To estimate the ORR when a dose of 105 mg/m2 LY2606368 every 14 days is administered in patients with Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) that have platinum resistant/refractory disease. ; Secondary Objective: -To characterize the safety and toxicity profile of LY2606368 -To characterize the pharmacokinetics (PK) of LY2606368 -To estimate secondary efficacy measures including disease control rate (DCR), duration of response (DoR), progression free survival (PFS), and overall survival (OS) - To evaluate the association between best tumor response and change from baseline in lung cancer-specific symptoms, symptomatic distress, activity status, overall quality of life, total Lung Cancer Symptom Scale (LCSS) score and Average Symptom Burden Index (ABSI) for patients who have platinum-sensitive or platinum-resistant/refractory SCLC ;Primary end point(s): Best overall response as determined by RECIST 1.1;Timepoint(s) of evaluation of this end point: Disease assessment starting at 6 weeks and continuing every 6 weeks until disease progression or participant discontinuation (estimated 14 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -AEs, SAEs, ECGs, vital signs, physical examination and laboratory measurements -PK profile of LY2606368: maximum concentration (Cmax) and time of maximal concentration (tmax) -Disease control rate -Duration of response -Progression free survival -Overall survival -Lung cancer symptoms (LCSS), total LCSS and Average Symptom Burden Index (ASBI) ; Timepoint(s) of evaluation of this end point: -Weekly for AEs, SAEs, every 2 weeks for ECGs, vital signs, physical exam during treatment and 30 days after treatment(estimated 18 weeks) -Cmax and tmax: either post dose and/or predose LY2606368 (estimated 14 weeks) -DCR:Radiologic assessment starting at 6 weeks and every 6 weeks until PD (estimated at 14 weeks) -DoR:Time from an objective response assessment until disease progression or death from any cause in absence of progressive disease (estimated at 14 weeks) -PFS:Time from enrollment until the first radiographic documentation of progressive disease or death from any cause in absence on progressive disease (estimated at 18 weeks) -OS:Time from enrollment until death from any cause (estimated at 15 months) -Lung cancer symptoms, total LCSS and ASBI (estimated at 42 weeks) | — |
Countries
France, Germany, Greece, Korea, Republic of, Netherlands, Spain, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly and Company
Outcome results
None listed