Your session is about to expire
← Back to Search
CDK4/6 Inhibitor
Osimertinib + Abemaciclib for Non-Small Cell Lung Cancer after Osimertinib Resistance
Phase 2
Waitlist Available
Led By Hatim Husain, MD
Research Sponsored by University of California, San Diego
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 6 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 10 Other Conditions
Summary
This trial will explore a new strategy to treat patients with EGFR mutated lung cancer who have developed resistance to osimertinib.
Who is the study for?
Adults over 18 with Stage IV, recurrent or metastatic non-small cell lung cancer that has an EGFR mutation and have shown resistance to osimertinib treatment. They must be able to swallow pills, not have serious heart conditions or uncontrolled illnesses, and agree to use contraception. Those with certain prior treatments or health issues like interstitial lung disease are excluded.
What is being tested?
The trial is testing the combination of Osimertinib and Abemaciclib in patients whose non-small cell lung cancer has become resistant to Osimertinib alone. It aims to see if this combo can overcome resistance and improve outcomes.
What are the potential side effects?
Potential side effects may include diarrhea, fatigue, skin rash, dry skin, nail toxicity (changes in nails), mouth sores, decreased appetite, high blood pressure (hypertension), low white blood cell count (neutropenia) which can increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival at 6 months
Side effects data
From 2020 Phase 4 trial • 60 Patients • NCT0385355110%
Blood creatine phosphokinase increased
10%
Fatigue
8%
Decreased appetite
8%
Diarrhoea
8%
Cough
7%
Mucosal inflammation
7%
Rash
7%
Pain in extremity
7%
Constipation
7%
Thrombocytopenia
7%
Paronychia
3%
Dyspnoea
2%
Dengue fever
2%
Disease progression
2%
Cardio-respiratory arrest
2%
Cataract
2%
Mouth Ulceration
2%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm, POCExperimental Treatment2 Interventions
Single arm, POC Safety and Efficacy
Osimertinib 80 mg QD Abemaciclib 150mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Osimertinib
FDA approved
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,466,366 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,723 Total Patients Enrolled
Hatim Husain, MD5.01 ReviewsPrincipal Investigator - University of California, San Diego
University of California, San Diego
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a lung disease called interstitial lung disease, except if it was caused by radiation treatment and is not currently being treated or causing symptoms.You have certain health conditions like unstable angina, congestive heart failure, or gastrointestinal diseases that may affect how well you can take the study medication. You also have mental health issues or other personal situations that may make it difficult for you to participate or follow the study requirements.You have received chemotherapy or experimental treatment within the three weeks before the study.You are allergic to osimertinib or any of the ingredients in the trial drugs.You have a history of heart-related conditions like fainting, abnormal heart rhythms, or sudden cardiac arrest.You have a lung disease that is currently causing symptoms or requiring treatment with steroids. Your eligibility for the study will be decided on a case-by-case basis.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm, POC
Awards:
This trial has 3 awards, including:- 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.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.