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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
Must not have
Major surgical procedure within 14 days of the first dose of study drug
Clinically significant, uncontrolled, cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing BLU-945, a new drug that targets cancer proteins, alone or with osimertinib. It focuses on patients with specific EGFR gene mutations. The drug aims to block a protein that helps cancer cells grow.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery within the last 2 weeks.
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I have a serious heart condition that is not under control.
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I don't have lasting side effects from previous treatments above mild level.
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I have a heart condition that affects my heart's electrical activity.
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I do not have any active, uncontrolled infections or known COVID-19.
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I have a known bleeding disorder or brain bleed.
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My cancer has spread to my brain or spine, causing worsening symptoms or needing more steroids.
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My lung cancer is of mixed type or has changed its cell type.
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My tumor has other known genetic changes.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
[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 2] Overall response rate (ORR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
Secondary study objectives
[Phase 1 and Phase 2] Assess treatment-induced modulation of EGFR pathway biomarkers.
[Phase 1 and Phase 2] Duration of response (DOR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 1] Overall response rate (ORR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
2023
Completed Phase 2
~160
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Neurofibromatosis type 2 (NF2) include targeted therapies such as bevacizumab, which inhibits VEGF to reduce tumor blood supply, and everolimus, which disrupts mTORC1 pathways to inhibit cell growth. Lapatinib, an EGFR/ErbB2 inhibitor, targets the EGFR family to reduce tumor cell survival and proliferation.
These treatments are important for NF2 patients as they offer targeted approaches to manage tumor growth and symptoms, potentially improving quality of life and reducing the need for surgery.
Summary statement novel agents in the treatment of lung cancer: Fifth Cambridge Conference assessing opportunities for combination therapy.Targeted molecular therapies against epidermal growth factor receptor: past experiences and challenges.ErbB/HER receptor activation and preclinical efficacy of lapatinib in vestibular schwannoma.
Summary statement novel agents in the treatment of lung cancer: Fifth Cambridge Conference assessing opportunities for combination therapy.Targeted molecular therapies against epidermal growth factor receptor: past experiences and challenges.ErbB/HER receptor activation and preclinical efficacy of lapatinib in vestibular schwannoma.
Find a Location
Who is running the clinical trial?
Blueprint Medicines CorporationLead Sponsor
29 Previous Clinical Trials
6,015 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.