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TerminatedPhase 1NCT05241873
Official study title

(Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations

Study summary

This is a Phase 1/2, open-label first-in-human study of the safety, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLU-451 monotherapy and BLU-451 in combination with platinum-based chemotherapy (carboplatin and pemetrexed). All participants will receive BLU-451 on a 21-day treatment cycle.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBLU-451 and Carboplatin

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 10, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?23 U.S. locations

Locations may change over time.

Who runs it?Blueprint Medicines Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Blueprint Medicines Corporation
Interventions being studied
Drug: BLU-451; Drug: Carboplatin; Drug: Pemetrexed
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Biomarkers
EGFR→
Treatment approach
Chemotherapy→
Study topics
Brain metastases→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • All participants:
  • Documented EGFR mutation, based on Next-generation sequencing (NGS) testing of tumor or liquid biopsy analyzed in a local Clinical Laboratory Improvement Amendments (CLIA) (or International Organization for Standardization (ISO) 15189)-certified or equivalent laboratory are required. Redacted copies of laboratory results must be available for Sponsor review.
  • Able to provide a new or archived pretreatment formalin-fixed, paraffin-embedded (FFPE) tumor sample. For participants who received EGFR-targeted therapy subsequent to the most recent archived biopsy, all efforts should be made to obtain a new biopsy unless it is not safe or feasible to obtain one.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Participants must be without seizures for at least 14 days prior to enrollment, and patients who receive treatment with anti-epileptic drugs must be on stable doses for at least 14 days prior to enrollment.
  • Adequate hematological, renal, and hepatic function: Participants in Phase 1
  • Histologically or cytologically confirmed metastatic NSCLC (stage IVA and IVB per American Joint Committee on Cancer (AJCC) 8th edition) or other metastatic cancers except for primary CNS tumors (Part 1A or Part 2 only).
  • Must have evaluable or measurable disease per RECIST v1.1.
  • Progression on or after or intolerance to most recent systemic therapy. Participants in Phase 2
  • Histologically or cytologically confirmed metastatic NSCLC (stage IVA and IVB per AJCC 8th edition).
  • Must have measurable disease by RECIST 1.1.
Reasons someone may not be able to joinExclusion criteria
  • Have disease that is suitable for local therapy administered with curative intent.
  • Have tumor that harbors known driver alterations (including, but not limited to ROS, BRAF V600E, ALK, RET, HER2, MET, KRAS, NTRK1/2/3, EGFR C797X, or EGFR T790M mutation). These criteria are not applicable to Phase 1 Part 1B.
  • Have NSCLC with mixed cell histology or a tumor with known histologic transformation (NSCLC to SCLC, SCLC to NSCLC, or epithelial to mesenchymal transition). Other protocol-defined inclusion and

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, California
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California
  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)Aurora, Colorado
  • Georgetown University Medical CenterWashington D.C., District of Columbia
  • Northwestern Memorial HospitalChicago, Illinois
  • Massachusetts General HospitalBoston, Massachusetts
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania
  • The University of Texas M.D. Anderson Cancer CenterHouston, Texas
  • New Experimental Therapeutics of Virginia (NEXT Oncology)Fairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 10, 2025. Always confirm current availability with the study team.

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