A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02779751
• Other study ID #: 16177
• Secondary ID: I3Y-MC-JPCE2015-
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 14, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: March 15, 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a Stage IV diagnosis of 1 of the following: Part A: NSCLC (Kirsten rat sarcoma mutant [KRAS mt], PD-L1+); Part B: NSCLC (squamous histology); Part C: metastatic breast cancer (HR+, HER2-); or Part D: locally advanced or metastatic breast cancer (HR+, HER2-)

• Part A: must be chemotherapy naïve for metastatic NSCLC

• Part B: must have received at least 1 prior therapy containing platinum-based chemotherapy for advanced/metastatic NSCLC

• Part C: must have previously received prior treatment with at least 1 but no more than 2 chemotherapy regimens in the metastatic setting

• Part D: cannot have received endocrine therapy or chemotherapy as treatment in the locoregionally recurrent or metastatic breast cancer disease setting. Note: Participants may be enrolled if they received prior (neo)adjuvant chemotherapy or endocrine therapy for localized disease.

• Are amenable to provide tumor tissue prior to treatment and provide tumor tissue after treatment initiation (both mandatory).

• Have presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

• Have a performance status (PS) =1 on the Eastern Cooperative Oncology Group (ECOG) scale.

• Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.

• Have an estimated life expectancy of =12 weeks.

• For Part D: Have postmenopausal status due to surgical/natural menopause or chemical ovarian suppression (initiated 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin or radiation-induced ovarian suppression.

Exclusion Criteria:

• Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: subjects with controlled atrial fibrillation for >30 days prior to study treatment are eligible.

• Have central nervous system (CNS) metastasis with development of associated neurological changes 14 days prior to receiving study drug.

• Have corrected QT interval of >470 milliseconds on screening electrocardiogram (ECG).

• Have history of interstitial lung disease or pneumonitis.

• Have history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years.

• Have received a live vaccination within 30 days of study start.

• Have received prior treatment with an anti PD-1, anti-programmed death ligand 1 (PD-L1), or anti cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent.

• For Part D Only:

• Have initiated bisphosphonates or approved RANK ligand (RANK-L) targeted agents (for example, denosumab) <7 days prior to Cycle 1 Day 1.

• Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer. Note: A participant may be enrolled if she received prior (neo)adjuvant endocrine therapy (including, but not limited to anti-estrogens or aromatase inhibitors) for localized disease.

• Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer. Note: Participants may be enrolled if they received prior (neo)adjuvant chemotherapy for localized disease.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Abemaciclib
Administered orally
• Pembrolizumab
Administered IV
• Anastrozole
Administered orally

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
Belgium	Centre Hospitalier Universitaire Sart Tilman	Liege
France	Centre Oscar Lambret	Lille	Nord-Pas-de-Calais
France	Hôpital Arnaud de Villeneuve - CHU Montpellier	Montpellier	Hérault
France	Hopital Larrey	Toulouse
Italy	Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori	Meldola	Forli
Italy	IRCCS Ospedale San Raffaele	Milano
Spain	Hospital Nuestra Senora de Sonsoles	Avila
Spain	Hospital San Pedro de Alcantara	Caceres
Spain	Hospital Madrid Norte Sanchinarro	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Taiwan	Tri-Service General Hospital	Neihu Taipei
Taiwan	Taipei Medical University- Shuang Ho Hospital	New Taipei City
Taiwan	Chi Mei Hospital - Liouying Branch	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Turkey	Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi	Istanbul
Turkey	Ege Universitesi Hastanesi	Izmir
United States	University of Colorado School of Medicine	Aurora	Colorado
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Karmanos Cancer Institute	Farmington Hills	Michigan
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Univ of California San Francisco	San Francisco	California
United States	Highlands Oncology Group - Duplicate 2	Springdale	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Belgium,  France,  Italy,  Spain,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs)		Baseline through Study Treatment Completion (Approximately 6 Months)
Primary	Number of Participants with Non-Serious Adverse Event(s)		Baseline through Study Treatment Completion (Approximately 6 Months)
Secondary	Objective Response Rate (ORR) per RECIST v1.1: Percentage of Participants With a Complete or Partial Response		Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)
Secondary	Disease Control Rate (DCR) per RECIST v1.1: Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease		Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)
Secondary	Duration of Response (DoR) per RECIST v1.1		Date of Complete Response or Partial Response to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 12 Months)
Secondary	Progression Free Survival (PFS) per RECIST v1.1		Baseline to Measured Progressive Disease or Death (Approximately 10 Months)
Secondary	Overall Survival (OS)		Baseline to Date of Death Due to Any Cause (Approximately 18 Months)
Secondary	Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib in Combination with Pembrolizumab with or without Anastrozole		Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles)

External Links

•   A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer