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Small Molecule Inhibitor

BLU-451 for Lung Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Blueprint Medicines Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed metastatic NSCLC stage IVA & IVB per AJCC 8th Edition (Phase 1 and Phase 2) or other metastatic cancers except for primary CNS tumors (Phase 1 only).
Documented EGFR Ex20ins based on NGS testing of tumor or liquid biopsy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-15 months
Awards & highlights

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.

Who is the study for?
Adults (18+) with advanced cancers that have a specific mutation called EGFR Exon 20 insertion, based on testing. They should not have seizures and must be generally healthy with good organ function. The trial is open to those who've progressed after systemic therapy or can't tolerate it, except for primary brain tumors.Check my eligibility
What is being tested?
The study tests BLU-451 alone and combined with chemotherapy drugs carboplatin and pemetrexed in patients with certain mutations in their cancer cells. Participants will receive treatment every 21 days to evaluate safety, how the body processes the drug, its effects on tumors, and overall anti-cancer activity.See study design
What are the potential side effects?
While specific side effects of BLU-451 are not listed here, common ones from similar treatments include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems; liver or kidney function changes; allergic reactions; and potential nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed to be advanced non-small cell lung cancer or another type of metastatic cancer, excluding brain tumors.
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My cancer has a specific EGFR mutation detected by a special test.
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I am undergoing or need platinum-based chemotherapy, unless it's not suitable for me.
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My cancer has spread, is measurable, and didn't respond to my last treatment.
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My lung cancer is confirmed to be at an advanced stage with measurable signs.
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My cancer has an EGFR mutation confirmed by a certified test.
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I am fully active or can carry out light work.
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I haven't had seizures for at least 14 days and my anti-epileptic drug doses have been stable for the same period.
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My cancer has spread, is measurable, and didn't respond to my last treatment.
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My lung cancer is at an advanced stage and can be measured for changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-15 months for reporting.

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 more
Secondary 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 more

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
~5250

Find a Location

Who is running the clinical trial?

Blueprint Medicines CorporationLead Sponsor
29 Previous Clinical Trials
5,877 Total Patients Enrolled

Media Library

BLU-451 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05241873 — Phase 1 & 2
Respiratory Diseases Research Study Groups: Phase I - Part 1A Dose Escalation, Phase II - Cohort 2D, Phase I - Part 1B Dose Escalation (US only), Phase II - Cohort 2B, Phase I - Part 2 BLU-451 Monotherapy Enrichment, Phase II - Cohort 2F, Phase II - Cohort 2A, Phase II - Cohort 2G, Phase II - Cohort 2E, Phase II - Cohort 2C
Respiratory Diseases Clinical Trial 2023: BLU-451 Highlights & Side Effects. Trial Name: NCT05241873 — Phase 1 & 2
BLU-451 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05241873 — Phase 1 & 2

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?
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
New Experimental Therapeutics of Virginia (NEXT Oncology)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
(Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations
2022. "(Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05241873.
All > Adenocarcinoma > Oncology
~34 spots leftby Aug 2024
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