Related Experiment Video
Updated: Oct 27, 2025
Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
Published on: November 22, 2021
Neoadjuvant osimertinib with/without chemotherapy versus chemotherapy alone for EGFR-mutated resectable
Masahiro Tsuboi1, Walter Weder2, Carles Escriu3
1National Cancer Center Hospital East, Kashiwa, Chiba 277-8577, Japan.
Abstract:
Osimertinib is a third-generation, irreversible oral EGFR-tyrosine kinase inhibitor), that potently inhibits EGFR-tyrosine kinase inhibitor-sensitizing mutations and T790M resistance mutations together with efficacy in CNS metastases in patients with non-small-cell lung cancer (NSCLC). Here we describe the rationale and design for the Phase III NeoADAURA study (NCT04351555), which will evaluate neoadjuvant osimertinib with or without chemotherapy versus chemotherapy alone prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary end point is centrally assessed major pathological response at the time of resection. Secondary end points include event-free survival, pathological complete response, nodal downstaging at the time of surgery, disease-free survival, overall survival and health-related quality of life. Safety and tolerability will also be assessed. Trial Registration number: NCT04351555 (ClinicalTrials.gov).
Insights
The NeoADAURA study investigates neoadjuvant osimertinib for resectable EGFR-mutation-positive non-small-cell lung cancer. This approach aims to improve pathological response before surgery.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Osimertinib is a potent EGFR-tyrosine kinase inhibitor effective against sensitizing and T790M resistance mutations in non-small-cell lung cancer (NSCLC).
- It demonstrates efficacy in central nervous system (CNS) metastases.
- Neoadjuvant therapy aims to reduce tumor burden before surgery.
Purpose of the Study:
- To evaluate the efficacy and safety of neoadjuvant osimertinib, with or without chemotherapy, compared to chemotherapy alone.
- To assess outcomes in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC prior to surgery.
Main Methods:
- Phase III NeoADAURA study (NCT04351555).
- Patients receive neoadjuvant osimertinib with or without chemotherapy, or chemotherapy alone.
- Primary endpoint: major pathological response at resection.
Main Results:
- Study is ongoing; results are pending.
- Key secondary endpoints include event-free survival, pathological complete response, nodal downstaging, disease-free survival, overall survival, and quality of life.
Conclusions:
- The study will provide critical data on the neoadjuvant use of osimertinib in EGFR-mutation-positive NSCLC.
- Findings may establish a new standard of care for resectable NSCLC.
More Related Videos
09:38Establishment and Characterization of Three Afatinib-resistant Lung Adenocarcinoma PC-9 Cell Lines Developed with Increasing Doses of Afatinib
Published on: June 26, 2019
07:59Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Related Concept Videos
02:57Targeted Cancer Therapies
There are several types of targeted therapies against...
02:49Cancer Therapies
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
02:56Treatment Resistant Cancers