Osimertinib for Carcinoma, Non-Small-Cell Lung

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma, Non-Small-Cell Lung+5 More
Osimertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying osimertinib with or without bevacizumab for patients with EGFR positive non-small cell lung cancer that has spread to the brain.

Eligible Conditions
  • Carcinoma, Non-Small-Cell Lung
  • Brain
  • Metastatic Lung Non-Small Cell Carcinoma
  • Non-Small Cell Lung Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Non-Small-Cell Lung

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Up to 2 years

At 12 months
OS rate
Baseline to 2 years
Changes in the tumor immune microenvironment
Year 2
Overall survival (OS)
Year 2
Progression free survival (PFS)
Year 2
Time to central nervous system (CNS) progression
Up to 2 years
Angiogenic signature assessed in plasma by multiplex panel array
Biomarker analysis of angiogenesis and signaling pathways
Brain metastasis response rate
Circulating tumor deoxyribonucleic acid assessed in plasma
Incidence of adverse events
Intracranial response
Intracranial response rate
Molecular characterization
Objective response defined as a complete or partial response
Overall response rate
Time to intracranial progression

Trial Safety

Safety Progress

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

Other trials for Carcinoma, Non-Small-Cell Lung

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

Arm I (osimertinib, bevacizumab)
1 of 2
Arm II (osimertinib)
1 of 2
Experimental Treatment

112 Total Participants · 2 Treatment Groups

Primary Treatment: Osimertinib · No Placebo Group · Phase 2

Arm I (osimertinib, bevacizumab)Experimental Group · 3 Interventions: Bevacizumab, Laboratory Biomarker Analysis, Osimertinib · Intervention Types: Biological, Other, Drug
Arm II (osimertinib)Experimental Group · 2 Interventions: Laboratory Biomarker Analysis, Osimertinib · Intervention Types: Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,776 Total Patients Enrolled
522 Trials studying Carcinoma, Non-Small-Cell Lung
76,390 Patients Enrolled for Carcinoma, Non-Small-Cell Lung
Sarah B GoldbergPrincipal InvestigatorYale University Cancer Center LAO

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no prior treatment with an EGFR TKI.
The use of anti-convulsants is allowed, as long as the patient is on a stable dose with no seizure activity for at least 2 weeks prior to initiating trial therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.