FLAURA2

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

A Phase III, Open-label, Randomized Study of Osimertinib With or Without Platinum Plus Pemetrexed Chemo, as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).

Phase

Phase 3

Status

Active not recruiting

Conditions

Non-Small Cell Lung Cancer

Interventions

Osimertinib; Pemetrexed/Carboplatin; Pemetrexed/Cisplatin

Arms

• Osimertinib 80mg QD · Active comparator
• Osimertinib 80 mg QD and platinum-based chemotherapy · Experimental

Enrollment

587

Primary outcomes

• Adverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In Treatment Arms Only)
• Progression-free Survival (PFS) (Randomized Component)
• Sensitivity Analysis for Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment (Randomized Component)

Sponsor

AstraZeneca

Start

Jul 2, 2019

Primary completion

Apr 3, 2023

Results posted

Yes

Registry record

NCT04035486 · updated Sep 3, 2026

• Planchard D, Janne PA, Yang JC, Kobayashi K, Valdiviezo N, Fan Y, Kim TM, Galvez ML, Nishino K, Biswas B, Feng PH, Sriuranpong V, Koubkova L, Pinto GDJ, Escriu C, Tran TV, Takahashi T, Neron Y, Han JY, Figueroa A, Donachie V, Khullar A, Evans A, Albayaty M, Lee CK. Long-term safety of first-line osimertinib plus platinum-pemetrexed in EGFR-mutated advanced NSCLC: FLAURA2. Lung Cancer. 2026 Sep 14:109588. doi: 10.1016/j.lungcan.2026.109588. Online ahead of print. PubMed 42728193
• Janne PA, Planchard D, Kobayashi K, Yang JC, Liu Y, Valdiviezo N, Kim TM, Jiang L, Kagamu H, Yanagitani N, Wang J, Biswas B, Poltoratskiy A, Neron Y, Rojas C, Koubkova L, Escriu C, Ezeife DA, Mann H, Armenteros-Monterroso E, Rukazenkov Y, Lee CK; FLAURA2 Investigators. Survival with Osimertinib plus Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2026 Jan 1;394(1):27-38. doi: 10.1056/NEJMoa2510308. Epub 2025 Oct 17. PubMed 41104938
• Yang J, Olabode D, Sawant-Basak A, Baldry R, Vishwanathan K, Bachina S, Todd A, Ghiorghiu D, Rukazenkov Y, Zhou D, Shahraz A. Population Pharmacokinetics and Exposure-Response Analysis of First-Line Osimertinib Plus Chemotherapy in Patients with EGFR-Mutated Advanced NSCLC. Clin Pharmacol Ther. 2025 Nov;118(5):1110-1121. doi: 10.1002/cpt.3759. Epub 2025 Jul 10. PubMed 40637621
• Murat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18. PubMed 40311309
• Janne PA, Planchard D, Kobayashi K, Cheng Y, Lee CK, Valdiviezo N, Laktionov K, Yang TY, Yu Y, Kato T, Jiang L, Chewaskulyong B, Lucien Geater S, Maurel JM, Rojas C, Takahashi T, Havel L, Shepherd FA, Tanaka K, Ghiorghiu D, Amin NP, Armenteros-Monterroso E, Huang X, Chaudhry AA, Yang JC. CNS Efficacy of Osimertinib With or Without Chemotherapy in Epidermal Growth Factor Receptor-Mutated Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2024 Mar 1;42(7):808-820. doi: 10.1200/JCO.23.02219. Epub 2023 Dec 2. PubMed 38042525
• Planchard D, Janne PA, Cheng Y, Yang JC, Yanagitani N, Kim SW, Sugawara S, Yu Y, Fan Y, Geater SL, Laktionov K, Lee CK, Valdiviezo N, Ahmed S, Maurel JM, Andrasina I, Goldman J, Ghiorghiu D, Rukazenkov Y, Todd A, Kobayashi K; FLAURA2 Investigators. Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2023 Nov 23;389(21):1935-1948. doi: 10.1056/NEJMoa2306434. Epub 2023 Nov 8. PubMed 37937763
• 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. PubMed 34543864
• 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. PubMed 33610453
• 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. PubMed 33199228