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Two-Drug cocktail shows promise for tough cancers

NCT ID NCT02779751

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests whether combining two drugs, abemaciclib and pembrolizumab, is safe and effective for people with advanced non-small cell lung cancer or a certain type of breast cancer. About 100 participants with stage IV disease will receive the combination. The goal is to see if the drugs work together to shrink tumors or slow cancer growth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Non-small cell lung cancer

Contacts and locations

Locations

  • Centre Hospitalier Universitaire Sart Tilman

    Liège, 4000, Belgium

  • Centre Oscar Lambret

    Lille, Hauts-de-France, 59020, France

  • Chi Mei Hospital - Liouying Branch

    Tainan, 73657, Taiwan

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Ege Universitesi Hastanesi

    Izmir, 35100, Turkey (Türkiye)

  • Highlands Oncology Group - Duplicate 2

    Springdale, Arkansas, 72762, United States

  • Hopital Larrey

    Toulouse, 31059, France

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050, Spain

  • Hospital Nuestra Senora de Sonsoles

    Ávila, 05004, Spain

  • Hospital San Pedro de Alcantara

    Cáceres, 10003, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier, Hérault, 34090, France

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

    Meldola, Forli, 47014, Italy

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Karmanos Cancer Institute

    Farmington Hills, Michigan, 48334, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • Taipei Medical University- Shuang Ho Hospital

    New Taipei City, 235, Taiwan

  • Tri-Service General Hospital

    Neihu Taipei, 114, Taiwan

  • Univ of California San Francisco

    San Francisco, California, 94158, United States

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.