A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) (FLAURA2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04035486

Recruitment Status : Active, not recruiting

First Posted : July 29, 2019

Last Update Posted : February 14, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Results Submitted - Quality Control (QC) Review Has Not Concluded

Results information for an applicable clinical trial (ACT) is posted within 30 days of submission even if the submission has not completed the ClinicalTrials.gov Results Quality Control (QC) review process. Results information is submitted to ClinicalTrials.gov by the sponsor or investigator, and National Library of Medicine (NLM) staff assess for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.

All versions of ACT results information submissions that have not completed the QC review process are posted on ClinicalTrials.gov (since January 2020). After the QC review process is completed, the results information is posted without QC review comments and previous versions are archived.

Recruitment Status :	Active, not recruiting
Actual Primary Completion Date :	April 3, 2023
Estimated Study Completion Date :	June 3, 2026

Submission Cycle	Results Submitted to ClinicalTrials.gov	Results Returned after Quality Control Review
1	February 20, 2024	March 18, 2024 Submission with QC Comments
2	April 12, 2024	May 7, 2024 Submission with QC Comments

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Planchard D, Feng PH, Karaseva N, Kim SW, Kim TM, Lee CK, Poltoratskiy A, Yanagitani N, Marshall R, Huang X, Howarth P, Janne PA, Kobayashi K. Osimertinib plus platinum-pemetrexed in newly diagnosed epidermal growth factor receptor mutation-positive advanced/metastatic non-small-cell lung cancer: safety run-in results from the FLAURA2 study. ESMO Open. 2021 Oct;6(5):100271. doi: 10.1016/j.esmoop.2021.100271. Epub 2021 Sep 17.

White MN, Piotrowska Z, Stirling K, Liu SV, Banwait MK, Cunanan K, Sequist LV, Wakelee HA, Hausrath D, Neal JW. Combining Osimertinib With Chemotherapy in EGFR-Mutant NSCLC at Progression. Clin Lung Cancer. 2021 May;22(3):201-209. doi: 10.1016/j.cllc.2021.01.010. Epub 2021 Jan 27.

Asahina H, Tanaka K, Morita S, Maemondo M, Seike M, Okamoto I, Oizumi S, Kagamu H, Takahashi K, Kikuchi T, Isobe T, Sugio K, Kobayashi K. A Phase II Study of Osimertinib Combined With Platinum Plus Pemetrexed in Patients With EGFR-Mutated Advanced Non-Small-cell Lung Cancer: The OPAL Study (NEJ032C/LOGIK1801). Clin Lung Cancer. 2021 Mar;22(2):147-151. doi: 10.1016/j.cllc.2020.09.023. Epub 2020 Oct 16.

To Top