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

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	Inferior DFS

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

1. 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 PubMed NCT02511106
   1. 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 PubMed
   2. 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 PubMed

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	Inferior PFS

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

1. 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 PubMed NCT03521154