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CDK4/6 Inhibitor

Abemaciclib for Lung Cancer (JUNIPER Trial)

Phase 3
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization date through end of study (up to 32 months)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study whether the drug abemaciclib is safe and effective for people with lung cancer.

Who is the study for?
This trial is for adults with stage IV non-small cell lung cancer (NSCLC) who have specific KRAS mutations and whose disease has worsened after platinum-based chemotherapy. They must be in good physical condition, not have received certain unapproved drugs recently, and cannot have unstable brain metastases or a history of serious heart rhythm problems.
What is being tested?
The study is testing the safety and effectiveness of abemaciclib, a new drug, on participants with NSCLC who carry certain KRAS mutations. The trial will also involve erlotinib to see how well these treatments work together against this type of lung cancer.
What are the potential side effects?
Possible side effects from abemaciclib may include diarrhea, fatigue, low white blood cell counts which can increase infection risk, liver enzyme changes suggesting liver injury, deep vein thrombosis or pulmonary embolism. Erlotinib can cause rash and diarrhea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization date through end of study (up to 32 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization date through end of study (up to 32 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Secondary study objectives
Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score
Malignant Neoplasms
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
+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%
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
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
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%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AbemaciclibExperimental Treatment1 Intervention
200 milligrams (mg) abemaciclib administered, orally, every 12 hours plus best supportive care (BSC) on Days 1 to 28 (28 day cycles).
Group II: ErlotinibActive Control1 Intervention
150 mg erlotinib administered, orally, every 24 hours plus BSC on Days 1 to 28 (28 day cycles).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,671 Previous Clinical Trials
3,228,569 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
426,194 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02152631 — Phase 3
Non-Small Cell Lung Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02152631 — Phase 3
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02152631 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Abemaciclib, Erlotinib
~41 spots leftby Nov 2025
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