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CDK4/6 Inhibitor

Abemaciclib Combo for Lung Cancer or alternatively, if focusing on breast cancer: Abemaciclib Combo for Breast Cancer

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to date of death due to any cause (approximately 18 months)

Awards & highlights

Study Summary

This trial is testing a new cancer drug combo to see if it's safe and effective against NSCLC and HR+ breast cancer.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer or hormone receptor positive, HER2- breast cancer. Participants must have a good performance status and may have had certain prior treatments depending on the study part they're in. They should not have used specific immune therapies before, no recent live vaccines, and must be free of certain heart and lung conditions.Check my eligibility

What is being tested?

The trial tests abemaciclib combined with pembrolizumab's safety and effectiveness against advanced NSCLC or HR+, HER2- breast cancer. It aims to see how well this combination works for patients who meet specific previous treatment criteria.See study design

What are the potential side effects?

Potential side effects include diarrhea, fatigue, low blood counts leading to increased infection risk, liver problems, blood clots, shortness of breath, rash or other skin changes. The severity can vary from mild to serious.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is advanced and falls into one of the specified categories.

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I have not received chemotherapy for my metastatic NSCLC.

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I've had 1 or 2 chemotherapy treatments for my cancer after it spread.

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I can provide samples of my tumor before and after starting treatment.

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I have had platinum-based chemotherapy for my advanced lung cancer.

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I have stopped all cancer treatments and recovered from their immediate side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to date of death due to any cause (approximately 18 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to date of death due to any cause (approximately 18 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of death due to any cause (approximately 18 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

Duration of Response (DoR) per RECIST v1.1

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

+3 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490

91%

Diarrhoea

67%

Nausea

48%

Fatigue

45%

Decreased appetite

35%

Vomiting

27%

Anaemia

26%

Abdominal pain

23%

Asthenia

23%

Neutrophil count decreased

21%

Cough

20%

Constipation

20%

Headache

19%

Arthralgia

18%

White blood cell count decreased

18%

Neutropenia

15%

Alopecia

14%

Platelet count decreased

14%

Dry mouth

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Pyrexia

11%

Dyspepsia

11%

Oedema peripheral

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Dry skin

Thrombocytopenia

Pruritus

Lacrimation increased

Dehydration

Alanine aminotransferase increased

Flatulence

Urinary tract infection

Upper respiratory tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Rash

Gastrooesophageal reflux disease

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Sepsis

Hip fracture

Pneumonitis

Fall

Lung infection

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Trial Design

4Treatment groups

Experimental Treatment

Group I: NSCLC SquamousExperimental Treatment2 Interventions

Abemaciclib 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.

Group II: NSCLC KRAS mt, PD-L1+Experimental Treatment2 Interventions

Abemaciclib 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.

Group III: HR+, HER2- Metastatic Breast CancerExperimental Treatment2 Interventions

Group IV: HR+, HER2- Locally Advanced or Metastatic Breast CancerExperimental Treatment3 Interventions

Abemaciclib 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1710

Pembrolizumab

2017

Completed Phase 2

~2010

Anastrozole

2019

Completed Phase 4

~10090

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,613 Previous Clinical Trials

3,200,829 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,471 Total Patients Enrolled

Study DirectorEli Lilly and Company

1 Previous Clinical Trials

2 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02779751 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: NSCLC KRAS mt, PD-L1+, NSCLC Squamous, HR+, HER2- Metastatic Breast Cancer, HR+, HER2- Locally Advanced or Metastatic Breast Cancer

Non-Small Cell Lung Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02779751 — Phase 1

Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02779751 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the medical literature like on Abemaciclib?

"Abemaciclib was first researched at UP Health System Marquette in 2006. Since then, 385 studies have completed, with 1151 more presently active. Many of these ongoing trials are based in Aurora, Colorado."

Answered by AI

What is the maximum level of danger that Abemaciclib has been shown to cause in patients?

"Abemaciclib's safety is less well-known because it is still in Phase 1 clinical trials."

Answered by AI

For what purpose is Abemaciclib typically prescribed?

"Abemaciclib is the treatment of choice for unresectable melanoma. Additionally, Abemaciclib has shown efficacy in treating other conditions such as microsatellite instability high, high risk of recurrence, and disease."

Answered by AI

Is this study being conducted in more than one location within the city?

"To help with the burden of travel, the researchers conducting this study have chosen to set up shop in 6 locations. These sites are in Aurora, San Francisco, Detroit, and 3 other cities."

Answered by AI

Recent research and studies

JTO Clinical and Research ReportsJournal

Abemaciclib in Combination with Pembrolizumab for Stage IV Kras-mutant or Squamous NSCLC: A Phase 1b Study

Pujol, Jean-Louis, Johan Vansteenkiste, Luis Paz-Ares Rodríguez, Vanesa Gregorc, Julien Mazieres, Mark Awad, Pasi A. Jänne, et al.. 2021. “Abemaciclib in Combination with Pembrolizumab for Stage IV Kras-mutant or Squamous NSCLC: A Phase 1b Study”. JTO Clinical and Research Reports. Elsevier BV. doi:10.1016/j.jtocrr.2021.100234.

clinicaltrials.govStudy

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

2016. "A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02779751.

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