Osimertinib for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Cancer Center, New York, NYNon-Small Cell Lung Cancer+5 MoreOsimertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well osimertinib, surgery, and radiation therapy work together to treat patients with EGFR mutated non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Stage IIIB Lung Cancer
  • Stage IV Lung Cancer
  • Stage IVB Lung Cancer
  • Stage IVA Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Osimertinib
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Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 4 years

Year 4
Progression free survival (PFS)
Year 4
Overall survival
Day 30
Incidence of adverse events
Up to 4 years
PFS in oligometastatic subgroup
Time to appearance of new metastases
Time to progression of target lesions

Trial Safety

Safety Progress

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

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Osimertinib
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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

Group II (no LCT)
1 of 2
Group I (LCT)
1 of 2

Experimental Treatment

173 Total Participants · 2 Treatment Groups

Primary Treatment: Osimertinib · No Placebo Group · Phase 2

Group II (no LCT)
Drug
Experimental Group · 1 Intervention: Osimertinib · Intervention Types: Drug
Group I (LCT)Experimental Group · 3 Interventions: Radiation Therapy, Therapeutic Conventional Surgery, Osimertinib · Intervention Types: Radiation, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7130
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,124 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,827 Previous Clinical Trials
1,792,673 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
108 Previous Clinical Trials
5,395 Total Patients Enrolled
Yasir ElaminPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can swallow pills.
You are expected to live for at least 12 more weeks.
You are eligible for treatment at the location where the disease is present.
References

Frequently Asked Questions

How extensive is the participation of individuals in this research endeavor?

"Affirmative. According to information available on clinicaltrials.gov, this research is actively enlisting participants; the protocol was first distributed in January 17th 2018 and most recently adjusted on September 22nd 2022. The trial necessitates 143 individuals from 4 sites for completion." - Anonymous Online Contributor

Unverified Answer

Is there still an opportunity to be a participant in this trial?

"As per clinicaltrials.gov, this medical trial is presently recruiting patients. The experiment was first announced on January 17th 2018 and the most recent update occurred on September 22nd 2022." - Anonymous Online Contributor

Unverified Answer

What verifiable evidence exists that demonstrates Osimertinib's safety for treatment?

"Considering the lack of evidence demonstrating its efficacy, our team at Power gave Osimertinib a safety rating of 2." - Anonymous Online Contributor

Unverified Answer

What is the breadth of locales in which this experiment is being conducted?

"At present, 4 medical centres across America are enrolling patients for this clinical trial. In addition to Houston, Denver and San Francisco, there is another clinic located in a nearby city. To reduce travel requirements it would be advisable to select the centre closest to you if you decide to participate." - Anonymous Online Contributor

Unverified Answer

Can you outline the previous research conducted on Osimertinib?

"Osimertinib was initially studied in 2013 at Research Site and has since been the focus of 169 completed clinical trials. There are presently 101 active studies occurring, with many of these being conducted out of Houston, Texas." - Anonymous Online Contributor

Unverified Answer

Is this an innovative research effort?

"AstraZeneca sponsored the earliest clinical trial of Osimertinib in 2013, involving 603 participants. After successful Phase 1 & 2 trials were completed, there are now 101 active studies for this drug occurring across 1059 cities in 51 countries worldwide." - 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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