Osimertinib for Non Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non Small Cell Lung Cancer+1 MoreOsimertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of osimertinib alone to osimertinib with SRS for brain metastases in patients with newly diagnosed EGFR positive lung cancer.

Eligible Conditions
  • Non Small Cell Lung Cancer
  • Metastatic Brain Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 2 years

1 year
Intracranial progression free survival
2 years
Exposure to osimertinib
Intracranial overall response rate
Neurocognitive function
Overall survival
Quality of life
Rate of radionecrosis
Time to distant progression
Time to stereotactic radiosurgery (SRS)
Time to whole brain radiotherapy (WBRT)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Single Arm
10%Blood creatine phosphokinase increased
10%Fatigue
8%Decreased appetite
8%Diarrhoea
8%Cough
7%Thrombocytopenia
7%Pain in extremity
7%Constipation
7%Rash
7%Mucosal inflammation
7%Paronychia
3%Dyspnoea
2%Cataract
2%Cardio-respiratory arrest
2%Deep Vein Thrombosis
2%Mouth Ulceration
2%Dengue fever
2%Disease progression
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03853551) in the Single Arm ARM group. Side effects include: Blood creatine phosphokinase increased with 10%, Fatigue with 10%, Decreased appetite with 8%, Diarrhoea with 8%, Cough with 8%.

Trial Design

2 Treatment Groups

SRS + Osimertinib
1 of 2
Osimertinib alone
1 of 2

Active Control

Experimental Treatment

76 Total Participants · 2 Treatment Groups

Primary Treatment: Osimertinib · No Placebo Group · Phase 2

Osimertinib alone
Drug
Experimental Group · 1 Intervention: Osimertinib · Intervention Types: Drug
SRS + OsimertinibActiveComparator Group · 2 Interventions: Osimertinib, Stereotactic radiotherapy · Intervention Types: Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Sunnybrook Health Sciences CentreOTHER
604 Previous Clinical Trials
1,469,111 Total Patients Enrolled
British Columbia Cancer AgencyLead Sponsor
163 Previous Clinical Trials
90,054 Total Patients Enrolled
AstraZenecaIndustry Sponsor
3,992 Previous Clinical Trials
247,502,873 Total Patients Enrolled
Princess Margaret Hospital, CanadaOTHER
114 Previous Clinical Trials
30,012 Total Patients Enrolled
Shilo V Lefresne, MD, FRCPCPrincipal InvestigatorBC Cancer, Vancouver Centre
Cheryl Ho, MD, FRCPCPrincipal InvestigatorBC Cancer, Vancouver Centre

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have asymptomatic or minimally symptomatic brain metastases.
You must be over 6 months old and have a life expectancy of at least 6 months.
You are willing to abstain from sexual activity or willing to use double-barrier method during sexual intercourse.