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


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
Blood creatine phosphokinase increased
Decreased appetite
Mucosal inflammation
Pain in extremity
Cardio-respiratory arrest
Mouth Ulceration
Dengue fever
Disease progression
Deep Vein Thrombosis
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.
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
Completed Phase 4
Biospecimen Collection
Completed Phase 1
Computed Tomography
Completed Phase 2
Magnetic Resonance Imaging
Completed Phase 3
FDA approved

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
~12 spots leftby Jul 2024