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CDK4/6 Inhibitor
Abemaciclib for Non-Small Cell 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
JUNIPER 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.Check my eligibility
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.See study design
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.
JUNIPER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization date through end of study (up to 32 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization date through end of study (up to 32 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
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 moreSide effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
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%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
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
JUNIPER 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
2,613 Previous Clinical Trials
3,200,476 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,799 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of fainting, irregular heartbeats, or sudden cardiac arrest.My cancer has a specific KRAS mutation in codons 12 or 13.My cancer has worsened after platinum chemotherapy and one other treatment, or I can't have more standard treatments.I haven't taken any unapproved drugs within the last 3 weeks.My brain scans show stable cancer spread to the brain, not needing steroids.I have not been in a study or taken drugs targeting CDK4 and CDK6 before.My condition is stage IV non-small cell lung cancer.I stopped all cancer treatments at least 3 weeks ago for strong drugs, or 2 weeks for others.I am fully active or restricted in physically strenuous activity but can do light work.
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Abemaciclib
- Group 2: Erlotinib
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other examples of Abemaciclib's efficacy?
"Abemaciclib was first trialed over 18 years ago at Mayo Clinic's Rochester location. As of now, 446 similar studies have been completed with 144 more currently underway across the globe; a significant portion of these are located in Joplin, Missouri."
Answered by AI
Has the federal government given its stamp of approval to Abemaciclib?
"Abemaciclib's safety is estimated to be a 3. This is because it is a Phase 3 trial, which means that there is evidence from earlier trials to support both its efficacy and safety."
Answered by AI
How many different hospitals are a part of this clinical trial?
"To make participating more convenient for patients, this clinical trial has 62 locations. These include cities such as Joplin, Louisville and Omaha. You can find the full list of sites on our website."
Answered by AI
For what types of illnesses is Abemaciclib most often prescribed?
"Abemaciclib is most often given to patients with pancreatic carcinoma. However, it has also shown efficacy in treating other conditions such as advanced hr + her2 - breast cancer, malignant neoplasms, and disease progression after chemotherapy."
Answered by AI
Are investigators actively looking for new participants for this clinical trial?
"This clinical trial is not currently recruiting patients. However, the study was most recently updated on 8/8/2022 and it first posted on 10/3/2014. If you are seeking other studies, there are 1806 trials for non-small cell lung carcinoma (nsclc) and 144 studies involving Abemaciclib that are actively looking for participants."
Answered by AI
How many individuals are being asked to participate in this research project?
"This particular trial is no longer recruiting patients, as indicated by its last edit date of 8/8/2022. However, there are 1806 other studies that are currently enrolling nsclc patients and 144 trials for Abemaciclib admitting patients."
Answered by AI
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