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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 up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%

Dry mouth

14%

Platelet count decreased

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Oedema peripheral

11%

Dyspepsia

11%

Pyrexia

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Thrombocytopenia

Lacrimation increased

Dehydration

Dry skin

Pruritus

Alanine aminotransferase increased

Flatulence

Upper respiratory tract infection

Urinary tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Gastrooesophageal reflux disease

Rash

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Lung infection

Sepsis

Fall

Hip fracture

Pneumonitis

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1890

Pembrolizumab

2017

Completed Phase 3

~3150