Non-small cell lung cancer, EGFR-mutated - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main NSCLC page for regimens that include active anticancer treatment.
Last updated on 2024-12-02:2 regimens on this page
2 variants on this page
=Adjuvant therapy=
==Placebo==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Wu et al. 2020 (ADAURA)	2015-11 to 2019-02 	Phase 3 (C)	Osimertinib	Shorter DFS1 (primary endpoint)DFS48: 38% vs 73%(HR 3.70, 95% CI 2.94-4.76)Shorter OS2 (secondary endpoint)OS60: 73% vs 85%(HR 2.04, 95.03% CI 1.37-3.03)
1Reported efficacy is based on the January 2023 update.
2Reported efficacy is based on the June 2023 update.
No active antineoplastic treatment after surgery.
====Biomarker eligibility criteria====
*ADAURA: EGFR exon 19 deletion or p.L858R mutation, alone or in combination with other EGFR mutations
====Preceding treatment====
*Surgery
===References===
#ADAURA: Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. Epub 2020 Sep 19. link to original article EuroPMC NCT02511106
##HRQoL analysis: Majem M, Goldman JW, John T, Grohe C, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Li S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Atagi S, Zeng L, Kulkarni D, Medic N, Tsuboi M, Herbst RS, Wu YL. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial. Clin Cancer Res. 2022 Jun;28(11):2286-2296. link to original article link to EuroPMC
##Update: Herbst RS, Wu YL, John T, Grohe C, Majem M, Wang J, Kato T, Goldman JW, Laktionov K, Kim SW, Yu CJ, Vu HV, Lu S, Lee KY, Mukhametshina G, Akewanlop C, de Marinis F, Bonanno L, Domine M, Shepherd FA, Urban D, Huang X, Bolanos A, Stachowiak M, Tsuboi M. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial. J Clin Oncol. 2023 Apr 1;41(10):1830-1840. Epub 2023 Jan 31. link to original article link to PMC article EuroPMC
##Update: Tsuboi M, Herbst RS, John T, Kato T, Majem M, Grohé C, Wang J, Goldman JW, Lu S, Su WC, de Marinis F, Shepherd FA, Lee KH, Le NT, Dechaphunkul A, Kowalski D, Poole L, Bolanos A, Rukazenkov Y, Wu YL; ADAURA Investigators. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. N Engl J Med. 2023 Jul 13;389(2):137-147. Epub 2023 Jun 4. link to original article EuroPMC
##HRQoL analysis: John T, Grohé C, Goldman JW, Shepherd FA, de Marinis F, Kato T, Wang Q, Su WC, Choi JH, Sriuranpong V, Melotti B, Fidler MJ, Chen J, Albayaty M, Stachowiak M, Taggart S, Wu YL, Tsuboi M, Herbst RS, Majem M. Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial. J Thorac Oncol. 2023 Sep;18(9):1209-1221. Epub 2023 May 24. link to original article EuroPMC
=Maintenance after definitive therapy for inoperable disease=
==Placebo==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Lu et al. 2024 (LAURA)	2018-08 to 2022-07 	Phase 3 (C)	Osimertinib	Shorter PFSMedian PFS: 5.6 vs 39.1 mo(HR 6.25, 95% CI 4.17-10.00)
No active antineoplastic treatment after chemoradiotherapy.
====Biomarker eligibility criteria====
*EGFR exon 19 deletion or p.L858R mutation, alone or in combination with other EGFR mutations
====Preceding treatment====
*Platinum-based chemoradiotherapy induction
===References===
#LAURA: Lu S, Kato T, Dong X, Ahn MJ, Quang LV, Soparattanapaisarn N, Inoue T, Wang CL, Huang M, Yang JC, Cobo M, Özgüroğlu M, Casarini I, Khiem DV, Sriuranpong V, Cronemberger E, Takahashi T, Runglodvatana Y, Chen M, Huang X, Grainger E, Ghiorghiu D, van der Gronde T, Ramalingam SS; LAURA Trial Investigators. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024 Aug 15;391(7):585-597. Epub 2024 Jun 2. link to original article EuroPMC NCT03521154
##Update: Lu S, Ahn MJ, Reungwetwattana T, Özgüroğlu M, Kato T, Yang JC, Huang M, Fujiki F, Inoue T, Quang LV, Sriuranpong V, Vicente D, Fuentes C, Chaudhry AA, Poole L, Armenteros Monterroso E, Rukazenkov Y, van der Gronde T, Ramalingam SS. Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study. Ann Oncol. 2024 Dec;35(12):1116-1125. Epub 2024 Sep 16. link to original article EuroPMC
Category:Non-small cell lung cancer regimens
Category:Null regimens
Category:Biomarker-specific pages
Category:Non-small cell lung cancers