Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV 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: Part A: NSCLC, KRASmt, PD-L1+; Chemotherapy naïve for metastatic NSCLC Part B: NSCLC, squamous subtype; Must have received only 1 prior therapy containing platinum based chemotherapy for metastatic NSCLC Part C: HR+, HER2- breast cancer; Must have received at least 1 but no more than 2 chemotherapy regimens for metastatic breast cancer All patients: amendable to provide tumor tissue prior to treatment and during treatment; ECOG PS =65 years) no F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: -Have CNS metastasis with associated neurological changes 14 days prior to receiving study drug -QTc interval of >470msec on screening ECG -History of interstitial lung disease -Active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years -Recently treated with an anti-PD-1 or PD-L1 or anti-CTLA-4 agent -Previously received treatment with any CDK4 or CDK6 inhibitor -Have history of or current pneumonitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize further the safety profile of the combination of abemaciclib and pembrolizumab;Secondary Objective: -To characterize further the safety profile of the combination of abemaciclib and pembrolizumab -To assess the preliminary efficacy of abemaciclib in combination with pembrolizumab -To characterize the PK of abemaciclib and pembrolizumab when given in combination ;Primary end point(s): The safety endpoints per CTCAE v 4.0, NCI 2009 and will include but are not limited to the following: •TEAEs, ECIs, SAEs, and hospitalizations •Clinical laboratory tests, vital signs, and physical examinations ;Timepoint(s) of evaluation of this end point: Safety evaluations will occur at each study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •ORR per tumor assessment using RECIST v1.1 •PFS rate at 24 weeks per RECIST v1.1 •DoR per RECIST v1.1 •DCR per RECIST v1.1 •OS Abemaciclib and pembrolizumab concentrations in plasma or serum Pain and disease-related symptoms assessed by MDASI;Timepoint(s) of evaluation of this end point: Radiologic assessment is done every 6 weeks for 48 weeks, then every 9 weeks thereafter. | — |
Countries
Belgium, France, Italy, Spain, Taiwan, Turkey, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed