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Clinical Trial Summary

This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-945, a selective EGFR inhibitor.


Clinical Trial Description

The study will include a dose-escalation portion in patients with EGFR-mutated NSCLC who have previously received at least 1 prior EGFR-targeted TKI, followed by expansion groups consisting of patients with tumors harboring specific mutation profiles: EGFR T790M and C797S mutation (Group 1); EGFR T790M but not C797S (Group 2); or EGFR C797S but not T790M (Group 3). ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Antineoplastic Agents
  • Bronchial Neoplasms
  • Carcinoma
  • Carcinoma, Bronchogenic
  • Carcinoma, Non-Small-Cell Lung
  • EGF-R Positive Non-Small Cell Lung Cancer
  • EGFR Activating Mutation
  • EGFR Gene Mutation
  • EGFR T790M
  • Lung Diseases
  • Lung Neoplasms
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neoplasms, Nerve Tissue
  • Protein Kinase Inhibitors
  • Respiratory Tract Disease
  • Respiratory Tract Diseases
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms

NCT number NCT04862780
Study type Interventional
Source Blueprint Medicines Corporation
Contact Blueprint Medicines
Phone 617-714-6707
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date June 30, 2021
Completion date January 31, 2025

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