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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-)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to date of death due to any cause (approximately 18 months)
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had interstitial lung disease or pneumonitis.
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I have an autoimmune disease or have been on steroids or immune drugs for the past 2 years.
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I have not had a live vaccine in the last 30 days.
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I have been treated with drugs targeting PD-1, PD-L1, or CTLA-4.

Timeline

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
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Flatulence
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Gastroenteritis viral
1%
Atypical pneumonia
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
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
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 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
Anastrozole
2019
Completed Phase 4
~6260
Abemaciclib
2019
Completed Phase 2
~1800
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,218,010 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,163 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
~12 spots leftby Jul 2025
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