Study of Osimertinib in Patients With a Lung Cancer With Brain or

Status Active, not recruiting

Clinical Trial Summary

Treatment of non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation is mainly based on tyrosine kinase inhibitors (TKIs) targeting EGFR. 1st or 2nd generation inhibitors have been shown to be superior to chemotherapy in terms of Progression-Free Survival (PFS) when used as 1st line treatment. In case of progression at several metastatic sites, systemic treatment will be considered and will depend on the presence of the TKI resistance mutation, the T790M mutation. In the presence of the T790M mutation, osimertinib is superior to chemotherapy in terms of progression-free survival, while in the absence of the T790M mutation, platinum salt chemotherapy is recommended. In case of local progression, treatment of the site in progression by radiotherapy and/or surgery is considered. As these local treatments can cause long-term adverse effects, systemic treatments are increasingly being considered in this indication. Brain and leptomeningeal metastases are the most frequent isolated site of progression in EGFR mutated patients treated with TKI. The high frequency of isolated cerebral and leptomeningeal progression is a consequence of the lower diffusion of 1st and 2nd generation TKIs in the central nervous system (CNS). Osimertinib is a 3rd generation TKI that has the particularity of overcoming the T790M mutation and having greater brain penetration than 1st or 2nd generation TKIs, which could make it an attractive therapeutic option in the event of brain progression or leptomeningeal progression. However, its efficacy in patients with cerebral or leptomeningeal metastases is still poorly understood.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04233021
Study type	Interventional
Source	Intergroupe Francophone de Cancerologie Thoracique
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	July 16, 2020
Completion date	February 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04074096` - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis	Phase 2
Recruiting	`NCT04474925` - Pre- Versus Post-operative SRS for Resectable Brain Metastases	Phase 3
Recruiting	`NCT05358340` - Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions	N/A
Recruiting	`NCT05559853` - Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
Completed	`NCT03189381` - Pilot Phase 2 Study Whole Brain Radiation Therapy With Simultaneous Integrated Boost for Patients With Brain Metastases	N/A
Completed	`NCT02082587` - Toronto BNB Pilot Study	N/A
Terminated	`NCT01551680` - A Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib in Multiple Non Operable Brain Metastases	Phase 1
Terminated	`NCT00717275` - Study of Temozolomide to Treat Newly Diagnosed Brain Metastases	Phase 2
Recruiting	`NCT05048212` - A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases	Phase 2
Recruiting	`NCT03714243` - Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases	N/A
Recruiting	`NCT05573815` - Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images	N/A
Recruiting	`NCT04899908` - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases	Phase 2
Completed	`NCT04507217` - Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC	Phase 2
Recruiting	`NCT05452005` - Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer	Phase 1
Recruiting	`NCT06457906` - SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC	Phase 3
Completed	`NCT04170777` - Perfexion Registration Using CBCT
Recruiting	`NCT03027544` - Tomotherapy for Refractory Brain Metastases	N/A
Completed	`NCT04178330` - Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases	N/A
Terminated	`NCT02187822` - Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases	Phase 1
Terminated	`NCT00538343` - RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation — ORBITAL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms