News - EGFR exon 20 mutation

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov)

P1, N=105, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Oct 2026 | Trial primary completion date: Mar 2026 --> Oct 2026

4 days ago

Trial completion date • Trial primary completion date

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation

Mekinist (trametinib) • gefitinib • Kisqali (ribociclib) • Tabrecta (capmatinib) • naporafenib (ERAS-254) • nazartinib (EGF816)

10d

First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations (clinicaltrials.gov)

P1/2, N=251, Recruiting, Pierre Fabre Medicament | N=185 --> 251 | Trial completion date: Jun 2028 --> Dec 2029 | Trial primary completion date: Jun 2027 --> Dec 2029

10 days ago

Enrollment change • Trial completion date • Trial primary completion date • First-in-human

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)

EGFR mutation • HER-2 mutation • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation

STX-721

12d

Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer (clinicaltrials.gov)

P2, N=60, Not yet recruiting, Jonsson Comprehensive Cancer Center

12 days ago

New P2 trial

MET (MET proto-oncogene, receptor tyrosine kinase)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • MET overexpression • EGFR exon 20 mutation

CONFIRM anti-Total c-MET (SP44) Rabbit Monoclonal Primary Antibody • VENTANA® MET (SP44) RxDx Assay

Tagrisso (osimertinib) • Emrelis (telisotuzumab vedotin-tllv) • simmitinib (SYHA1817)

15d

Efficacy and safety of later-line targeted therapies in advanced non-small cell lung cancer with EGFR exon 20 insertion mutations: a systematic review. (PubMed, Front Pharmacol)

Recent developments in targeted therapies, including agents such as amivantamab, mobocertinib, and sunvozertinib, have shown promise in patients with pretreated ex20ins-positive NSCLC. No amendments were made to the registered protocol after commencement of the review. The full review protocol can be accessed on the PROSPERO database (Registration number: CRD420251056825).

15 days ago

Review • Journal • IO biomarker

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

Exkivity (mobocertinib) • Zegfrovy (sunvozertinib)

26d

CHRYSALIS-2: A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)

P1, N=701, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2026 --> Mar 2028

26 days ago

Trial completion date

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR expression • EGFR exon 20 mutation

Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib)

A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)

P2, N=43, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2026 --> Dec 2025 | Trial primary completion date: Jul 2026 --> Dec 2025

1 month ago

Trial completion • Trial completion date • Trial primary completion date

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib)

Comparing the effect of traditional and novel tyrosine kinase inhibitors for epidermal growth factor receptor exon 20 insertions by molecular dynamics simulation. (PubMed, J Int Med Res)

When binding to osimertinib, ASV- and SVD-EGFR still revealed two energy minima on their free energy landscapes, but with considerably less conformational probability distribution at collective variable 2 >1.00 Å. In contrast, mobocertinib eliminated the energy minima at collective variable 2 >1.00 Å while decreasing the K745-E762 salt bridge formation rates.ConclusionsMobocertinib outperforms osimertinib in targeting specific subtypes of EGFR exon 20 insertions, highlighting its ability to restore the inactive state of this protein.

1 month ago

Journal

EGFR (Epidermal growth factor receptor)

EGFR exon 20 insertion • EGFR wild-type • EGFR exon 20 mutation

Tagrisso (osimertinib) • Exkivity (mobocertinib)

Genetic modulation of ABCB1: Sunvozertinib reverses ABCB1-mediated multidrug resistance in cancer cells. (PubMed, Cancer Genet)

Furthermore, treatment with sunvozertinib did not change protein expression or subcellular localization of ABCB1. Altogether, these data demonstrate that sunvozertinib, when combined with other conventional chemotherapeutic agents, can overcome MDR and improve therapeutic effect.

1 month ago

Journal

EGFR (Epidermal growth factor receptor) • ABCB1 (ATP Binding Cassette Subfamily B Member 1) • ABCG2 (ATP Binding Cassette Subfamily G Member 2) • ABCC1 (ATP Binding Cassette Subfamily C Member 1)

EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

Zegfrovy (sunvozertinib)

2ms

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) (clinicaltrials.gov)

P1/2, N=315, Active, not recruiting, Dizal Pharmaceuticals | Trial completion date: Jul 2025 --> Dec 2025

2 months ago

Trial completion date

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)

EGFR mutation • HER-2 mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

Zegfrovy (sunvozertinib)

2ms

Advanced lung adenocarcinoma with rare EGFR exon 21 T854A mutation: a case report on increased dose osimertinib following resistance. (PubMed, Am J Transl Res)

Subsequently, the patient started gefitinib treatment, and 3 months later, the treatment effect assessment showed a partial response (PR) at regular follow-up according to RECIST evaluation criteria...Two months later, imaging examination showed that the lesions in various parts of the body were stable. Except for dryness of oral and nasal mucosa, the patient did not experience other serious adverse reactions.

2 months ago

Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR L858R • EGFR amplification • EGFR exon 20 insertion • EGFR exon 20 mutation

Tagrisso (osimertinib) • gefitinib • Cabometyx (cabozantinib tablet)

2ms

FAVOUR: Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation (clinicaltrials.gov)

P1, N=30, Active, not recruiting, Allist Pharmaceuticals, Inc. | Trial completion date: Aug 2025 --> Feb 2026

2 months ago

Trial completion date

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation • EGFR positive

Ivesa (firmonertinib)

2ms

Premature Deaths and Life-Years Lost From Lack of Amivantamab in Brazil's Unified Health System. (PubMed, JCO Glob Oncol)

Delayed SUS incorporation of amivantamab may result in over a 1,000 preventable deaths and life-years lost among Brazilian EGFR exon 20-mutated NSCLC. Urgent real-world studies and cost-effectiveness analyses are needed.

2 months ago

Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

docetaxel