Study of Abemaciclib with Pembrolizumab in Patients with Stage IV Lung Cancer or Breast Cancer

Phase 1

• Conditions: Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer; MedDRA version: 20.0Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005156-94-BE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

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 <= 1;
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 37
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 38

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>-To assess the preliminary efficacy of abemaciclib in combination with pembrolizumab<br>-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:<br>•TEAEs, ECIs, SAEs, and hospitalizations<br>•Clinical laboratory tests, vital signs, and physical examinations<br>;Timepoint(s) of evaluation of this end point: Safety evaluations will occur at each study visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •ORR per tumor assessment using RECIST v1.1 <br>•PFS rate at 24 weeks per RECIST v1.1 <br>•DoR per RECIST v1.1 <br>•DCR per RECIST v1.1 <br>•OS <br>Abemaciclib and pembrolizumab concentrations in plasma or serum <br>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.