Tyrosine Kinase Inhibitor

Osimertinib for Lung Cancer

Phase 2

Waitlist Available

Led By Sarah B Goldberg

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior treatment with an EGFR TKI; patient may have received prior chemotherapy for early-stage or advanced disease but this is not required; prior immunotherapy is not allowed

Life expectancy of greater than 3 months

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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

Non-Small Cell Lung Cancer (NSCLC)
Brain Metastasis
Lung Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You have not received treatment with a certain type of medication for your cancer before. You may have received chemotherapy, but not a specific type of medication called EGFR TKI. You also have not received immunotherapy before.

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You are expected to live for at least 3 more months.

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It's okay to take medication for seizures, as long as the dose has been consistent and there have been no seizures for at least 2 weeks before starting the trial treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival (PFS)

Secondary outcome measures

Brain metastasis response rate

Incidence of adverse events

Intracranial response

+7 more

Other outcome measures

Angiogenic signature assessed in plasma by multiplex panel array

Biomarker analysis of angiogenesis and signaling pathways

Changes in the tumor immune microenvironment

+2 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551

10%

Fatigue

10%

Blood creatine phosphokinase increased

Diarrhoea

Decreased appetite

Cough

Constipation

Mucosal inflammation

Paronychia

Pain in extremity

Thrombocytopenia

Rash

Dyspnoea

Cardio-respiratory arrest

Cataract

Mouth Ulceration

Dengue fever

Disease progression

Deep Vein Thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (osimertinib)Experimental Treatment1 Intervention

Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study.

Group II: Arm I (osimertinib, bevacizumab)Experimental Treatment6 Interventions

Patients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

FDA approved

Biopsy

2014

Completed Phase 4

~1120

Biospecimen Collection

2004

Completed Phase 1

~1470

Computed Tomography

2017

Completed Phase 2

~2890

Magnetic Resonance Imaging

2017

Completed Phase 3

~1250

Osimertinib

FDA approved

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,412 Previous Clinical Trials

41,238,954 Total Patients Enrolled

Sarah B GoldbergPrincipal Investigator

Yale University Cancer Center LAO

1 Previous Clinical Trials

66 Total Patients Enrolled

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02971501 — Phase 2

Lung Cancer Research Study Groups: Arm I (osimertinib, bevacizumab), Arm II (osimertinib)

Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT02971501 — Phase 2

Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02971501 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any analogous experiments involving Osimertinib?

"Currently, there are 450 trials exploring the effects of Osimertinib with 104 of them being in Phase 3. Many are concentrated around Taibei, Taiwan; however, it is being studied at over 21000 different locations world wide."

Answered by AI

What is the current enrollment capacity for this experiment?

"At this point, the trial is not actively recruiting. It was first created on June 23rd 2017 and modified as recently as July 2nd 2022. For those seeking alternatives, there are 3946 clinical trials for carcinoma non-small cell lung cancer as well as 450 studies searching for Osimertinib participants currently accepting enrolment."

Answered by AI

How does Osimertinib fare in terms of patient safety?

"The current level of safety data on osimertinib is assessed at 2, as the trial has reached Phase 2 but efficacy hasn't been fully established."

Answered by AI

Are there still sign-up opportunities for this research project?

"As evidenced by clinicaltrials.gov, the recruitment process for this medical study has ended; initial posting was June 23rd 2017 and it was last updated on July 2nd 2022. Despite the conclusion of this trial's participant search, there are currently 4396 other trials that remain eager to find subjects for their research."

Answered by AI

What diseases is Osimertinib typically employed to address?

"Primarily used to treat and manage malignant neoplasms, osimertinib has been successfully deployed in cases of recurrent platinum sensitive primary peritoneal cancer, stage IV epithelial ovarian cancer post-surgical resection, and locally advanced nonsquamous non-small cell lung cancers."

Answered by AI

How widespread is the implementation of this experiment?

"This study is seeking participants at Ohio State University Comprehensive Cancer Center in Columbus, Ohio, Yale University in New Haven, Connecticut and Nebraska Medicine-Bellevue in Bellevue. Additionally there are 18 other potential sites that can be found on the trial's website."

Answered by AI

Recent research and studies

Clinical Lung CancerJournal

Role of Antiangiogenic Agents Combined with EGFR Tyrosine Kinase Inhibitors in Treatment-naive Lung Cancer: A Meta-analysis

Deng, Zhujun, Yun Qin, Yongmei Liu, Yan Zhang, and You Lu. 2021. “Role of Antiangiogenic Agents Combined with EGFR Tyrosine Kinase Inhibitors in Treatment-naive Lung Cancer: A Meta-analysis”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2020.08.005.

clinicaltrials.govStudy

Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases

2018. "Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02971501.