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Osimertinib for Lung Carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Smilow Cancer Hospital-Derby Care Center, Derby, CTLung Carcinoma+6 MoreOsimertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding bevacizumab to osimertinib will help patients with EGFR-mutated, stage IIIB-IV non-small cell lung cancer live longer, as compared to osimertinib alone.

Eligible Conditions
  • Stage IVA Lung Cancer
  • Stage IIIB Lung Cancer
  • Non-Squamous Non-Small Cell Lung Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Stage IV Lung Cancer
  • Stage IVB Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Pembrolizumab
1
Flt3/MerTK Inhibitor MRX-2843
1
Osimertinib

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: From randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years

Year 10
Overall survival (OS)
Year 10
Progression-free survival (PFS)
Year 10
Central Nervous System
Year 10
Time to central nervous system progression
Up to 10 years
Best objective response rate
Mechanisms of resistance to AZD9291 (osimertinib) and AZD9291 (osimertinib) with bevacizumab first-line therapy through post-progression circulating tumor-derived deoxyribonucleic acid (ctDNA)
ctDNA clearance on study treatment
Day 30
Incidence of adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Pembrolizumab
1
Flt3/MerTK Inhibitor MRX-2843
1
Osimertinib

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 A (osimertinib)
1 of 2
Arm B (osimertinib, bevacizumab)
1 of 2

Active Control

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Osimertinib · No Placebo Group · Phase 3

Arm B (osimertinib, bevacizumab)Experimental Group · 2 Interventions: Bevacizumab, Osimertinib · Intervention Types: Biological, Drug
Arm A (osimertinib)
Drug
ActiveComparator Group · 1 Intervention: Osimertinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to documented disease progression per response evaluation criteria in solid tumors (recist) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,153 Previous Clinical Trials
41,162,009 Total Patients Enrolled
Helena A YuPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 22 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Rewritten Criterion: You have cancer that has spread to your brain, but your doctor has determined that you don't need immediate treatment for it. The cancer in your brain is not causing any neurological symptoms or bleeding, and you don't need to take steroids to manage it.
Rewritten Criterion: If you had another cancer before or have another cancer at the same time as the one being studied, it must not interfere with the safety or effectiveness of the trial treatment.
References

Frequently Asked Questions

What are some similar trials that have used Osimertinib in the past?

"Originally, osimertinib was studied in 2004 at Memoral Sloan Kettering Basking Ridge (Follow Up Only). So far, 1034 studies have been completed. There are currently 478 active clinical trials, many of which are based in Bethesda, Maryland." - Anonymous Online Contributor

Unverified Answer

How many candidates will be chosen for this experiment?

"That is correct, the clinicaltrials.gov website does show that this trial is currently enrolling patients. The trial was originally posted on October 22nd, 2020 and was most recently updated on October 27th, 2020. They are hoping to enroll 300 patients from 100 different locations." - Anonymous Online Contributor

Unverified Answer

What side effects does Osimertinib have on patients?

"Osimertinib has received a score of 3 for safety. This is due to Phase 3 trial data, which provides some evidence of efficacy as well as multiple rounds of data supporting safety." - Anonymous Online Contributor

Unverified Answer

What are the most common applications for Osimertinib?

"Osimertinib can be used to treat aggressive and recurrent cancers such as malignant neoplasms, platinum sensitive primary peritoneal cancer, and stage iv epithelial ovarian cancer." - Anonymous Online Contributor

Unverified Answer

Are people with the condition still able to participate in this research?

"That is correct. The clinical trial is currently recruiting patients. The first posting was on October 22, 2020, with the latest update on October 27, 2020. They are looking for 300 patients total from 100 different sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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