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Non Small Cell Lung CancerPhase 1NCT02779751

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

A Phase 1 study testing Abemaciclib, Pembrolizumab and Anastrozole in people with Non Small Cell Lung Cancer and Breast Cancer, run by Eli Lilly and Company at 24 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer, Breast Cancer
What is being tested?
Abemaciclib, Pembrolizumab and Anastrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
24 sitesin 7 countries
Study dates
14 Nov 2016to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

24 sites in 7 countries.

24 sites in 7 countries

United States7 sites

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Karmanos Cancer Institute

    Farmington Hills, Michigan, 48334

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Univ of California San Francisco

    San Francisco, California, 94158

  • Highlands Oncology Group - Duplicate 2

    Springdale, Arkansas, 72762

Other trials in United States

Spain4 sites

  • Hospital Nuestra Senora de Sonsoles

    Ávila, 05004

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050

Other trials in Spain

Taiwan4 sites

  • Tri-Service General Hospital

    Neihu Taipei, 114

  • Taipei Medical University- Shuang Ho Hospital

    New Taipei City, 235

  • Chi Mei Hospital - Liouying Branch

    Tainan, 73657

  • National Taiwan University Hospital

    Taipei, 10048

Other trials in Taiwan

France3 sites

  • Centre Oscar Lambret

    Lille, Hauts-de-France, 59020

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier, Hérault, 34090

  • Hopital Larrey

    Toulouse, 31059

Other trials in France

Belgium2 sites

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire Sart Tilman

    Liège, 4000

Other trials in Belgium

Italy2 sites

  • Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

    Meldola, Forli, 47014

  • IRCCS Ospedale San Raffaele

    Milan, 20132

Other trials in Italy

Turkey (Türkiye)2 sites

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

    Istanbul, 34098

  • Ege Universitesi Hastanesi

    Izmir, 35100

Other trials in Turkey (Türkiye)

About this study

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

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.

Medical subject headings
Carcinoma, Non-Small-Cell Lung, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02779751
Study groupRoleWhat they receive
NSCLC KRAS mt, PD-L1+ExperimentalAbemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Receives: Drug: Abemaciclib; Drug: Pembrolizumab
NSCLC SquamousExperimentalAbemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Receives: Drug: Abemaciclib; Drug: Pembrolizumab
HR+, HER2- Metastatic Breast CancerExperimentalAbemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Receives: Drug: Abemaciclib; Drug: Pembrolizumab
HR+, HER2- Locally Advanced or Metastatic Breast CancerExperimentalAbemaciclib given orally Q12H on days 1 to 21 of each 21 day cycle in combination with pembrolizumab given IV on day 1 of each 21 day cycle and anastrozole given orally Q24H on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Receives: Drug: Abemaciclib; Drug: Pembrolizumab; Drug: Anastrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs)

    Measured: Baseline through Study Treatment Completion (Approximately 6 Months)

  2. Number of Participants with Non-Serious Adverse Event(s)

    Measured: Baseline through Study Treatment Completion (Approximately 6 Months)

Secondary outcomes (6)

  1. Objective Response Rate (ORR) per RECIST v1.1: Percentage of Participants With a Complete or Partial Response

    Measured: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)

  2. Disease Control Rate (DCR) per RECIST v1.1: Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease

    Measured: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 6 Months)

  3. Duration of Response (DoR) per RECIST v1.1

    Measured: Date of Complete Response or Partial Response to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 12 Months)

  4. Progression Free Survival (PFS) per RECIST v1.1

    Measured: Baseline to Measured Progressive Disease or Death (Approximately 10 Months)

  5. Overall Survival (OS)

    Measured: Baseline to Date of Death Due to Any Cause (Approximately 18 Months)

  6. Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib in Combination with Pembrolizumab with or without Anastrozole

    Measured: Predose Cycle One Day One through Predose Cycle Eight Day One (21 Day Cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2016 (estimated)
  2. Study start14 Nov 2016
  3. Primary completion3 Feb 2020
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779751
Sponsor's protocol ID
16177
Other IDs
I3Y-MC-JPCE, 2015-005156-94, KEYNOTE 287, 2015
Status last verified
Jan 2026
First submitted
19 May 2016
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Pujol JL, Vansteenkiste J, Paz-Ares Rodriguez L, Gregorc V, Mazieres J, Awad M, Janne PA, Chisamore M, Hossain AM, Chen Y, Beck JT. Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC: A Phase 1b Study. JTO Clin Res Rep. 2021 Sep 25;2(11):100234. doi: 10.1016/j.jtocrr.2021.100234. eCollection 2021 Nov.

    PubMed 34746886

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abemaciclib, Pembrolizumab and Anastrozole in people with Non Small Cell Lung Cancer and Breast Cancer, run by Eli Lilly and Company at 24 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Spain, Taiwan, France, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with One or More Serious Adverse Event(s) (SAEs) (time frame: Baseline through Study Treatment Completion (Approximately 6 Months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02779751, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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