BLU-945 for Respiratory Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Respiratory Diseases+23 MoreBLU-945 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug that targets the EGFR protein. The drug is being tested to see if it is safe and effective at treating cancer.

Eligible Conditions
  • Respiratory Diseases
  • Cancer
  • Epidermal Growth Factor Receptor C797S Mutation
  • Protein Kinase Inhibitors
  • Chemotherapy
  • Adenocarcinoma
  • Epidermal Growth Factor Receptor L858R Mutation
  • Epidermal Growth Factor Receptor Activating Mutation
  • Lung Cancer
  • Epidermal Growth Factor Receptor Gene Mutations
  • EGFR Mutation-Associated Tyrosine Kinase Inhibitor Resistance
  • Epidermal Growth Factor Receptor Exon 19 Deletion
  • Bronchial Tumors
  • Tumors
  • Lung Disease
  • Neurofibromatosis
  • Non-Small-Cell Lung Carcinoma
  • Epidermal Growth Factor Receptor T790M Mutation
  • Non-Small Cell Lung Cancer (EGFR Positive)

Treatment Effectiveness

Study Objectives

8 Primary · 31 Secondary · Reporting Duration: Up to 42 months

Up to 12 months
[Phase 1] Determine recommended Phase 2 dose (RP2D) of BLU-945
[Phase 1] Determine recommended Phase 2 dose (RP2D) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-945
[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 1] Overall response rate (ORR)
[Phase 1] Overall response rate (ORR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 1] Rate and severity of adverse events
[Phase 1] Rate and severity of adverse events of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
Up to 25 months
[Phase 2] QTc Assessment
Up to 30 months
[Phase 2] Clinical benefit rate (CBR)
[Phase 2] Clinical benefit rate (CBR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 2] Disease control rate (DCR)
[Phase 2] Disease control rate (DCR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 2] Overall response rate (ORR)
[Phase 2] Overall response rate (ORR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
Up to 42 months
[Phase 1 and Phase 2] AUC (0-24)
[Phase 1 and Phase 2] Accumulation ratio
[Phase 1 and Phase 2] Assess treatment-induced modulation of EGFR pathway biomarkers.
[Phase 1 and Phase 2] CL/F
[Phase 1 and Phase 2] Cmax
[Phase 1 and Phase 2] Ctrough
[Phase 1 and Phase 2] Duration of response (DOR)
[Phase 1 and Phase 2] Duration of response (DOR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 1 and Phase 2] R
[Phase 1 and Phase 2] T 1/2
[Phase 1 and Phase 2] Tlast
[Phase 1 and Phase 2] Tmax
[Phase 1 and Phase 2] Vz/F
[Phase 2] Assess intracranial rate
[Phase 2] Assess time to intracranial progression
[Phase 2] Central Nervous System Duration of Response (CNS-DOR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 2] Central Nervous System Overall Response Rate (CNS-ORR) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 2] Central Nervous System Progression Rate of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 2] Overall survival (OS)
[Phase 2] Overall survival (OS) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 2] Progression free survival (PFS)
[Phase 2] Progression free survival (PFS) of BLU-945 as monotherapy and BLU-945 in combination with osimertinib
[Phase 2] Rate and severity of adverse events
[Phase 2] Rate and severity of adverse events of BLU-945 as monotherapy and BLU-945 in combination with osimertinib

Trial Safety

Trial Design

7 Treatment Groups

BLU-945
1 of 7
Part 1A: BLU-945 as monotherapy
1 of 7
Phase 2, Group 1: BLU-945 as monotherapy
1 of 7
Phase 2, Group 2: BLU-945 as monotherapy
1 of 7
Part 1B: BLU-945 with osimertinib
1 of 7
Phase 2, Group 4: BLU-945 with osimertinib
1 of 7
Phase 2, Group 3: BLU-945 as monotherapy
1 of 7

Experimental Treatment

190 Total Participants · 7 Treatment Groups

Primary Treatment: BLU-945 · No Placebo Group · Phase 1 & 2

BLU-945
Drug
Experimental Group · 1 Intervention: BLU-945 · Intervention Types: Drug
Part 1A: BLU-945 as monotherapy
Drug
Experimental Group · 1 Intervention: BLU-945 · Intervention Types: Drug
Phase 2, Group 1: BLU-945 as monotherapy
Drug
Experimental Group · 1 Intervention: BLU-945 · Intervention Types: Drug
Phase 2, Group 2: BLU-945 as monotherapy
Drug
Experimental Group · 1 Intervention: BLU-945 · Intervention Types: Drug
Part 1B: BLU-945 with osimertinibExperimental Group · 2 Interventions: osimertinib, BLU-945 · Intervention Types: Drug, Drug
Phase 2, Group 4: BLU-945 with osimertinibExperimental Group · 2 Interventions: osimertinib, BLU-945 · Intervention Types: Drug, Drug
Phase 2, Group 3: BLU-945 as monotherapy
Drug
Experimental Group · 1 Intervention: BLU-945 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
osimertinib
2018
Completed Phase 2
~160

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 42 months

Who is running the clinical trial?

Blueprint Medicines CorporationLead Sponsor
27 Previous Clinical Trials
4,673 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must have experienced progressive disease while on osimertinib, and were able to tolerate prior osimertinib 80 mg QD dose.
You have metastatic non-small cell lung cancer with an activating EGFR mutation.
You have a tumor mutation profile determined locally via a Sponsor-approved testing methodology, using tumor tissue (ideally from a progressing lesion) and/or ctDNA in plasma.
Patients must have non-small cell lung cancer (NSCLC) harboring EGFR T790M and C797S mutations.
At each dose level, slots may be reserved for patients with the mutations of interest.

Who else is applying?

What state do they live in?
Nevada100.0%
How old are they?
65+100.0%
What site did they apply to?
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%