A medical research evaluating the safety and efficacy of two new medicines (Necitumumab and Abemaciclib), administered in combination in patients affected by a defined type of advanced lung cancer (Stage IV Non-Small-Cell Lung Cancer)
- Conditions
- on Small Cell Lung CancerMedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005042-21-BE
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 68
Patients are eligible to be included in the study only if they meet all of the following criteria:
[1]Histologically or cytologically confirmed NSCLC
•Part A: NSCLC Stage IV (any type)
•Part B: NSCLC Stage IV (squamous and nonsquamous)
[2]Stage IV disease at the time of study entry (American Joint Committee on Cancer [AJCC] Staging Manual, 7th Edition [Edge et al. 2009])
[3]Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Eisenhauer et al. 2009)
[4]The patient must have progressed after platinum-based chemotherapy AND have received a maximum of 1 other prior chemotherapy for advanced and/or metastatic disease OR must be judged by the physician as ineligible for further standard second-line chemotherapy. Prior treatment with EGFR-TKI and ALK inhibitors is mandatory in patients whose tumor has EGFR-activating mutations or ALK translocations. Prior targeting agents and neoadjuvant/adjuvant therapies are permitted with the exception of CDK4/6-targeting agents or necitumumab.
[5]The patient has tumor tissue available for biomarker analyses. The sample can be either 12 serially paraffin-embedded unstained tissue slides or a paraffin embedded tissue block.
[6]The patient has given written informed consent prior to any study specific procedures. Written consent may also be provided by a legal representative.
[7]The patient is 18 years or older if required by local law or regulations.
[8]The patient has resolution to Grade =1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy (with the exception of alopecia).
[9]The patient has an Eastern Cooperative Oncology Group performance status score of 0-1.
[10]Have the following laboratory values:
•hematologic: absolute neutrophil count ?1.5 × 109/L, platelets ?100 × 109/L, and hemoglobin ?9 g/dL. T ransfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to Cycle 1 Day 1 are not allowed.
•Serum albumin =25 g/L
•hepatic: bilirubin ?1.5 × the upper limit of normal (ULN), alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate transaminase (AST) ?3.0 times ULN. For patients with hepatic metastases, ALT and AST equaling =5.0 times ULN are acceptable.
•renal: serum creatinine ?1.2 x ULN or calculated creatinine clearance >50 mL/min (per the Cockcroft-Gault formula as defined in Attachment 5) for patients with creatinine >1.2 x ULN.
[11]are men who are sterile (including vasectomy confirmed by post-vasectomy semen analysis) or who agree to use a reliable method of birth control and to not donate sperm during the study (and for at least 12 weeks following the last dose of necitumumab and abemaciclib or country requirements, whichever is longer) OR
[12]are women who are either: (a) not of child-bearing potential due to surgical sterilization (at least 6 weeks following surgical bilatera
Patients will be excluded from the study if they meet any of the following criteria:
[15]The patient is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study treatment used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Prior treatment with CDK4/6-targeting agents or necitumumab is not permitted.
[16]The patient has undergone major surgery or received any investigational therapy in the 30-days prior to study enrollment.
[17]The patient has undergone chest irradiation within 4 weeks prior to receiving study treatment (except focal palliative irradiation, which is allowed up to 2 weeks prior to receiving study treatment).
[18]The patient has brain metastases that are symptomatic. (Patients who have completed radiotherapy for brain metastases at least 2 weeks prior to receiving study treatment, who are now non symptomatic or on stable dose of steroids or anticonvulsants during the 2 weeks prior to receiving study treatment, are eligible). Patients with asymptomatic brain metastases without need for treatment with steroids and who have not been treated with radiotherapy are eligible. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
[19]History of arterial or venous thromboembolism within 3 months prior to study enrollment. Patients with a history of venous thromboembolism beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin.
[20]History or evidence of current clinically relevant coronary artery disease = Grade III by the Canadian Cardiovascular Society Angina Grading Scale or uncontrolled congestive heart failure of current > Class III as defined by the New York Heart Association.
[21]The patient has experienced myocardial infarction within 6 months prior to study enrollment.
[22]The patient has active infection requiring systemic therapy, including active tuberculosis or known history of infection with the human immunodeficiency virus (HIV 1/2 antibodies), or hepatitis B (e.g., HBsAg reactive) and/or C virus (e.g., HCV RNA qualitative is detected).
[23]The patient has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance.
[24]The patient has a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
[25]The patient has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the patient’s ability to complete the study or sign an informed consent document.
[26]The patient has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab or abemaciclib, or any other contraindication to one of the administered treatments.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method