Small Molecule Inhibitor
BLU-451 for Lung Cancer
University of Pennsylvania Abramson Cancer Center, Philadelphia, PA
Targeting 21 different conditionsBLU-451 +2 morePhase 1 & 2RecruitingResearch Sponsored by Blueprint Medicines CorporationEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
° Prior treatment with at least 1 prior line of EGFR Ex20ins-targeted therapy is allowed but not required. EGFR Ex20ins targeted therapy includes amivantamab or mobocertinib. Other agents including investigational EGFR Ex20ins-targeted therapy or other approved EGFR-targeted TKIs are allowed with Sponsor Medical Monitor approval.
Any approved standard therapy that is available to the patient that is known to confer clinical benefit, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up12-15 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective. The drug will be given to patients once or twice a day for 21 days.
Eligible Conditions
- Lung Cancer
- Lung Disease
- Bronchial Tumors
- Non-Small Cell Lung Cancer
- Tumors
- EGFR Gene Mutation
- Epidermal Growth Factor Receptor
- Respiratory Diseases
- Epidermal Growth Factor Receptor Mutations
- Cancer
- Chemotherapy
- Brain Tumor
- EGFR Mutation
- Adenocarcinoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You may have received treatment for EGFR Ex20ins mutation using drugs like amivantamab or mobocertinib, but it is not necessary. If you have been treated with other drugs for EGFR Ex20ins mutation, you will need approval from the medical monitor.
Select...
You cannot participate if you are already receiving a treatment that is known to help your condition, unless it is not safe for you, or you choose not to receive it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I - Determine the Recommended Phase 2 Dose (RP2D) of BLU-451
Phase I - Determine the maximum tolerated dose (MTD) of BLU-451
Phase I - Rate and severity of Adverse Events (AEs) of BLU-451
+1 moreSecondary outcome measures
Phase I & II - The Clinical Benefit Rate (CBR) of BLU-451
Phase I & II - The Disease Control Rate (DCR) rate of BLU-451
Phase I & II - The Duration of Response (DOR) rate of BLU-451
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
10Treatment groups
Experimental Treatment
Group I: Phase II - Cohort 2GExperimental Treatment1 Intervention
Participants with EGFR atypical mutations (e.g., G719X, L861Q) who have not received prior systemic therapy in metastatic setting will receive BLU-451. Participants with with other atypical EGFR mutations, such as S768I, may be enrolled if approved by Sponsor Medical Monitor.
Group II: Phase II - Cohort 2FExperimental Treatment1 Intervention
Participants with EGFR atypical mutations (e.g., G719X, L861Q) who have previously received at least one EGFR tyrosine kinase inhibitor (TKI) will receive BLU-451. Participants with with other atypical EGFR mutations, such as S768I, may be enrolled if approved by Sponsor Medical Monitor.
Group III: Phase II - Cohort 2EExperimental Treatment1 Intervention
Participants with EGFR Ex20ins who have not received prior systemic therapy in metastatic setting will receive BLU-451.
Group IV: Phase II - Cohort 2DExperimental Treatment1 Intervention
Participants with EGFR Ex20ins who have previously received platinum-based chemotherapy and both amivantamab AND mobocertinib, OR received any investigational Ex20Ins targeted agent(s) will receive BLU-451. Participants with Ex20ins or atypical mutations enrolled in other cohorts and who have other oncogenic drivers by central testing at baseline will be moved to this arm.
Group V: Phase II - Cohort 2CExperimental Treatment1 Intervention
EGFR Ex20ins participants with at least one measurable lesion in brain per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 who have previously received platinum-based chemotherapy will receive BLU-451. Previous treatment with EGFR Ex20Ins-targeted therapies is allowed but not required.
Group VI: Phase II - Cohort 2BExperimental Treatment1 Intervention
EGFR Ex20ins participants who have previously received platinum-based chemotherapy but have not received a prior EGFR Ex20ins-targeted agent will receive BLU-451.
Group VII: Phase II - Cohort 2AExperimental Treatment1 Intervention
EGFR Ex20ins participants who have previously received platinum-based chemotherapy and either amivantamab or mobocertinib will receive BLU-451.
Group VIII: Phase I - Part 2 BLU-451 Monotherapy EnrichmentExperimental Treatment1 Intervention
BLU-451 enrichment at select doses.
Group IX: Phase I - Part 1B Dose Escalation (US only)Experimental Treatment3 Interventions
BLU-451 with dose escalation in combination with carboplatin and pemetrexed in participants with metastatic NSCLC with common EGFR mutations. This arm will enroll participants only in the United States.
Group X: Phase I - Part 1A Dose EscalationExperimental Treatment1 Intervention
BLU-451 monotherapy with dose escalation in participants with metastatic cancer with EGFR Ex20ins or other selected EGFR mutations that have progressed after prior systemic therapies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~4270
Find a site
Who is running the clinical trial?
Blueprint Medicines CorporationLead Sponsor
28 Previous Clinical Trials
5,816 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there a considerable number of locations in North America carrying out this trial?
"Patients may be enrolled at 6 different medical centres, including the University of Colorado's Anschutz Cancer Pavilion in Aurora and Laura & Isaac Perlmutter Cancer Center at NYU Langone Health in New York. Additionally, Dana-Farber Cancer Institute is accepting patients for this trial from Boston as well as other sites."
Answered by AI
How many individuals have been accepted to participate in this trial?
"Affirmative. Clinicaltrials.gov evidences that this medical trial, which was first posted on March 4th 2022, is actively recruiting and requires 150 participants from 6 distinct clinical sites to complete the study."
Answered by AI
Are any new participants being accepted at this time for the research?
"According to the clinicaltrials.gov webpage, this trial is presently enrolling participants with first postings occurring on March 4th 2022 and a recent edit made October 26th of the same year."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
New Experimental Therapeutics of Virginia (NEXT Oncology)
What portion of applicants met pre-screening criteria?
Met criteria