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(SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC

NCT04862780 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2025-02-10

No results posted yet for this study

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, as monotherapy or in combination with osimertinib.

Conditions

  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Respiratory Tract Neoplasms
  • Neoplasms
  • Neoplasms by Site
  • Lung Diseases
  • Respiratory Tract Disease
  • Carcinoma, Bronchogenic
  • Bronchial Neoplasms
  • Adenocarcinoma
  • Carcinoma
  • Neoplasms by Histologic Type
  • Neoplasms, Nerve Tissue
  • EGFR T790M
  • EGFR C797S
  • EGFR L858R
  • EGFR Gene Mutation
  • EGF-R Positive Non-Small Cell Lung Cancer
  • EGFR Exon 19 Deletion
  • EGFR Mutation Resulting in Tyrosine Kinase Inhibitor Resistance
  • EGFR Activating Mutation
  • Protein Kinase Inhibitors
  • Antineoplastic Agents
  • Thoracic Neoplasms

Interventions

DRUG

BLU-945

Oral administration

DRUG

osimertinib

Osimertinib tablets for oral administration

Sponsors & Collaborators

  • Blueprint Medicines Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2024-10-07
Completion
2024-10-07
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Japan
  • Netherlands
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04862780 on ClinicalTrials.gov