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EGFR Inhibitor
Osimertinib + BLU-945 for Non-Small Cell Lung Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Blueprint Medicines Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age at the time of signing the informed consent.
Previously received at least 1 prior EGFR-targeted TKI with activity against the T790M mutation, such as osimertinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug that targets the EGFR protein. The drug is being tested to see if it is safe and effective at treating cancer.
Who is the study for?
Adults with metastatic non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. They must have previously been treated with an EGFR-targeted therapy like osimertinib and shown disease progression on it. Participants need to be generally healthy, with a good performance status, and able to use contraception.Check my eligibility
What is being tested?
The trial is testing BLU-945 alone or combined with osimertinib for safety, tolerability, how the body processes it, its effects on the body, and its ability to fight cancer in patients whose NSCLC has certain EGFR mutations resistant to previous treatments.See study design
What are the potential side effects?
Potential side effects include typical reactions related to targeted cancer therapies such as skin rash, diarrhea, dry skin, nail changes; however detailed side effect profiles will be determined during this early phase of testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been treated with a drug targeting EGFR mutation before.
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My lung cancer is advanced and has a specific EGFR gene change.
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I am fully active or can carry out light work.
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My cancer's genetic changes were tested with approved methods.
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My NSCLC has specific EGFR mutations.
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I am 18 years old or older.
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I have been treated with a specific lung cancer medication before.
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My cancer progressed on osimertinib, but I tolerated the 80 mg daily dose well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
[Phase 1] Determine recommended Phase 2 dose (RP2D) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 1] Rate and severity of adverse events of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
+1 moreSecondary outcome measures
[Phase 1 and Phase 2] AUC (0-24)
[Phase 1 and Phase 2] Accumulation ratio
[Phase 1 and Phase 2] Assess treatment-induced modulation of EGFR pathway biomarkers.
+18 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Phase 2, Group 4: BLU-945 with osimertinibExperimental Treatment2 Interventions
Phase 2 expansion group for BLU-945 with osimertinib at a dose determined during Part 1B in patients
Group II: Phase 2, Group 3: BLU-945 as monotherapyExperimental Treatment1 Intervention
Phase 2 expansion group for BLU-945 as monotherapy at a dose determined during Part 1A in patients with EGFR C797S mutations
Group III: Phase 2, Group 2: BLU-945 as monotherapyExperimental Treatment1 Intervention
Phase 2 expansion group for BLU-945 as monotherapy at a dose determined during Part 1A in patients with EGFR T790M mutations
Group IV: Phase 2, Group 1: BLU-945 as monotherapyExperimental Treatment1 Intervention
Phase 2 expansion group for BLU-945 as monotherapy at a dose determined during Part 1A in patients with EGFR T790M and C797S mutations
Group V: Part 1B: BLU-945 with osimertinibExperimental Treatment2 Interventions
Phase 1 dose escalation of BLU-945 in combination with osimertinib 80 mg tablets for oral administration
Group VI: Part 1A: BLU-945 as monotherapyExperimental Treatment1 Intervention
Phase 1 dose escalation of BLU-945 as monotherapy at various dose levels
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
osimertinib
2018
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Blueprint Medicines CorporationLead Sponsor
29 Previous Clinical Trials
6,029 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a serious heart condition that is not under control.I received growth factor support for neutrophils or platelets within 2 weeks before starting the study drug.I don't have lasting side effects from previous treatments above mild level.My lung cancer is advanced and has a specific EGFR gene change.I have a heart condition that affects my heart's electrical activity.My NSCLC has specific EGFR mutations (T790M and C797S).I do not have any active, uncontrolled infections or known COVID-19.I am fully active or can carry out light work.I have a known bleeding disorder or brain bleed.My NSCLC has specific EGFR mutations.I have not had major surgery within the last 2 weeks.I have been treated with a drug targeting EGFR mutation before.I haven't had certain cancer treatments recently before starting the study drug.My cancer progressed despite taking osimertinib, but I tolerated the 80 mg daily dose well.I have a tumor that can be measured for changes in size.My cancer has spread to my brain or spine, causing worsening symptoms or needing more steroids.My cancer's genetic changes were tested with approved methods.My NSCLC has specific EGFR mutations.My lung cancer is of mixed type or has changed its cell type.I can stop taking any prohibited medications or herbal remedies 2 weeks before starting the study drug.My treatment plan may adjust based on specific genetic changes in my cancer.I have provided a tumor sample for analysis before starting treatment.I do not have active lung disease or lung inflammation from past treatments.My tumor has other known genetic changes.I am 18 years old or older.I have been treated with a specific lung cancer medication before.My cancer progressed on osimertinib, but I tolerated the 80 mg daily dose well.I have not been diagnosed or treated for another cancer within the last 2 years.I may be eligible for a specific dose level due to my cancer's genetic mutations.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2, Group 4: BLU-945 with osimertinib
- Group 2: Part 1A: BLU-945 as monotherapy
- Group 3: Phase 2, Group 1: BLU-945 as monotherapy
- Group 4: Phase 2, Group 2: BLU-945 as monotherapy
- Group 5: Part 1B: BLU-945 with osimertinib
- Group 6: Phase 2, Group 3: BLU-945 as monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial have a presence in multiple hospitals throughout the state?
"There are 10 sites currently running this clinical trial; a few notable locations include Los Angeles, La Jolla and Boston. If you enroll in the trial, selecting a site close to your location will minimize travel requirements."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
How old are they?
65+
What site did they apply to?
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
NYU Langone Health, Laura and Isaac Perlmutter Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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