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Osimertinib for Non-Small Cell Lung Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CANon-Small Cell Lung Carcinoma+9 MoreOsimertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the side effects and best dose of minnelide given with osimertinib to treat non-small cell lung cancer that has spread and has a mutation in the EGFR gene.

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Up to 2 years

Year 2
HSP levels pre and post therapy
Year 2
Overall survival
Up to 2 years
Cell free deoxyribonucleic acid (DNA) in blood
Determination of the exosomes
Duration of overall response
Evaluation of the microbiome
Evidence of anti-tumor activity of minnelide when in combination with osimertinib
Incidence of adverse events
Levels of minnelide in the blood
Objective response rate
Heat shock proteins
Progression-free survival (PFS)
Up to 28 days
Maximum tolerated dose (MTD) of osimertinib and minnelide
Recommended phase II dose (RP2D) of minnelide and osimertinib

Trial Safety

Safety Progress

1 of 3

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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

1 Treatment Group

Treatment (minnelide, osimertinib)
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Osimertinib · No Placebo Group · Phase 1

Treatment (minnelide, osimertinib)Experimental Group · 3 Interventions: Biopsy, Osimertinib, Triptolide Analog · Intervention Types: Procedure, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
524 Previous Clinical Trials
2,249,948 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,152 Previous Clinical Trials
41,162,969 Total Patients Enrolled
Erminia MassarelliPrincipal InvestigatorCity of Hope Medical Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be 18 years old or older.
You have a type of lung cancer called non-small cell lung cancer (NSCLC) that has advanced beyond the initial site. If you have locally advanced NSCLC, it cannot be treated with surgery, radiation, or chemoradiation that aims to cure the cancer.
You have a tumor that can be measured using the RECIST 1.1 criteria.
You or your legal representative have given permission for you to participate in the study and understand what it involves.
If you are a child, your agreement to participate will be asked for according to the rules of the institution.
You agree to have two research biopsies taken during the study.
If a biopsy of your tumor cannot be safely done, the study principal investigator (PI) may allow an exception.
You are able to perform daily activities without much difficulty, and your overall health is relatively good.
Your tumor has continued to grow, even after being treated with osimertinib, which is an approved medication.
Your tumor has certain mutations in the EGFR gene that make it sensitive to a type of medication called EGFR-TKI.
References

Frequently Asked Questions

Is enrollment available for this research trial at present?

"Yes, data hosted on clinicaltrials.gov affirms that this clinical research is actively welcoming participants. The trial was first made available for review on March 7th 2022 and has been recently refreshed as of August 2nd 2022. 30 individuals will be accepted at the single recruitment site." - Anonymous Online Contributor

Unverified Answer

Is this an innovative research endeavor?

"Currently, there are 101 active studies for Osimertinib that span 51 countries and 1059 cities. This medication was initially trialled in 2013, with AstraZeneca overseeing a Phase 1 & 2 trial involving 603 patients. Since then, 72 further investigations have been launched into this drug's potential efficacy." - Anonymous Online Contributor

Unverified Answer

What research has been conducted to explore the efficacy of Osimertinib?

"Presently, there are 101 studies for Osimertinib with 17 in the latter stage of testing. These trials can be found predominantly in Uniondale, NY as well as across 4702 other sites internationally." - Anonymous Online Contributor

Unverified Answer

To what extent can Osimertinib cause harm to individuals?

"The limited clinical data available surrounding osimertinib's safety and efficacy gives it a score of 1 on our scale." - Anonymous Online Contributor

Unverified Answer

How many participants are joining this research project?

"Affirmative. According to clinicaltrials.gov, this research trial is actively recruiting participants and has been since March 7th 2022. A total of 30 test subjects need to be sourced from a single medical facility before the last update on August 2nd 2022." - 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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