News - EGFR T790M - LARVOL VERI

17h

Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer (clinicaltrials.gov)

P1/2, N=66, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2025 --> Aug 2026

17 hours ago

Trial completion date

EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)

BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • ALK rearrangement • ROS1 rearrangement

Opdivo (nivolumab) • Yervoy (ipilimumab) • nintedanib

Australian Retrospective Analysis of EGFRm Advanced & Metastatic NSCLC Patients Treated With 1L or 2L Osimertinib. (clinicaltrials.gov)

P=N/A, N=350, Completed, AstraZeneca | Recruiting --> Completed

2 days ago

Trial completion

EGFR mutation • EGFR T790M

Tagrisso (osimertinib) • simmitinib (SYHA1817)

Endostar overcomes Osimertinib-resistance mediated EGFR-activation mutation, T790M and cis-C797S triple mutations via enhancing the binding of Osimertinib to EGFR protein. (PubMed, Life Sci)

This work demonstrated for the first time that Endostar enhanced the antitumor efficacy of Osimertinib, offering a potential therapeutic approach for patients harboring triple mutations.

2 days ago

Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR L858R • EGFR T790M

Tagrisso (osimertinib) • Endostar (recombinant human endostatin) • simmitinib (SYHA1817)

Prevalence and Clinical Characteristics of Germline Epidermal Growth Factor Receptor Mutations in the Southeastern Unites States. (PubMed, JCO Precis Oncol)

Our analysis represents the largest study to date assessing the prevalence of germline EGFR mutations from both patients with lung cancer and unselected cohorts of individuals and presents evidence for increased prevalence of EGFR T790M mutations within the Southeastern United States. Given the high prevalence and documented hereditary risk of germline EGFR mutations, future studies investigating the role of familial testing and screening in these individuals is warranted.

2 days ago

Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR T790M

Osimertinib-Induced Lung Injury and Treatment Rechallenge: Clinical Insights From a Case Report With a Comprehensive Literature Review. (PubMed, Clin Lung Cancer)

After resolution with corticosteroids, treatment was switched to afatinib. This study highlights the heterogeneous approaches to OILI and the potential feasibility of rechallenge in selected patients. Given the expanding osimertinib use for early and advanced stage NSCLC, further research is warranted to refine treatment decisions and optimize patient safety.

5 days ago

Review • Journal

EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)

EGFR mutation • MET amplification • EGFR T790M • MET mutation

Tagrisso (osimertinib) • Gilotrif (afatinib) • simmitinib (SYHA1817)

IM-BATTLE-2 Program: Trametinib and Pembrolizumab in Treating Patients With Recurrent Non-small Cell Lung Cancer That Is Metastatic, Unresectable, or Locally Advanced (clinicaltrials.gov)

P1/2, N=37, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027

6 days ago

Trial completion date • Trial primary completion date

ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)

EGFR T790M • ALK fusion

Keytruda (pembrolizumab) • Mekinist (trametinib)

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

7 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)

ROSE: Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study (clinicaltrials.gov)

P2, N=42, Active, not recruiting, AIO-Studien-gGmbH | Trial completion date: Dec 2026 --> Mar 2027

9 days ago

Trial completion date

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR T790M • EGFR positive

Tagrisso (osimertinib) • simmitinib (SYHA1817)

13d

Computationally guided design of N4-(2-methyl-2H-indazol-6-yl)-N2-phenylpyrimidine-2,4-diamine inhibitors of EGFR kinase targeting Cys797. (PubMed, Bioorg Med Chem)

Compound 19 was the most potent inhibitor of WT EGFR (3.0 nM) observed, more potent than the EGFR WT inhibitor Erlotinib (5.9 nM). Compounds 48 and 49 demonstrated better activity for the double-mutant EGFR (3.0 & 2.0 nM, respectively) than Osimertinib (12.8 nM)...Kinetic evaluation of 48 (propenamide moiety) vs 49 (acrylamide electrophile) confirms kinact/Ki values consistent with a covalent mode of action for the latter, but not the former. 2009 Elsevier Ltd.

13 days ago

Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR T790M • EGFR wild-type

Tagrisso (osimertinib) • erlotinib • simmitinib (SYHA1817)

14d

AURA17: Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific (clinicaltrials.gov)

P2, N=171, Completed, AstraZeneca | Active, not recruiting --> Completed

14 days ago

Trial completion

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X

Tagrisso (osimertinib)

14d

TROPION Lung15: A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)

P3, N=744, Recruiting, AstraZeneca | Active, not recruiting --> Recruiting

14 days ago

Enrollment open

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR S768I

cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • Datroway (datopotamab deruxtecan-dlnk) • simmitinib (SYHA1817)

14d

Targeting common EGFR mutations in NSCLC-review of global phase III trials of third-generation inhibitors. (PubMed, J Natl Cancer Inst)

The addition of osimertinib to curative-intent strategies have demonstrated improvements in disease-free survival and overall survival (OS) as adjuvant therapy in resected stage IB-IIIa patients, major pathological responses compared to chemotherapy when used as neoadjuvant therapy, and progression-free survival (PFS) compared to placebo when used as consolidation therapy in unresectable stage III patients. Currently, subsequent treatment recommendations include chemotherapy or datopotamab deruxtecan following progression on a third-generation EGFR-TKI combination and amivantamab plus platinum-based chemotherapy following progression on monotherapy. The treatment landscape for NSCLC with common EGFR mutations is rapidly evolving and third-generation EGFR-TKIs play an integral role in both the curative-intent and palliative settings.

14 days ago

P3 data • Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR T790M

Tagrisso (osimertinib) • Datroway (datopotamab deruxtecan-dlnk) • simmitinib (SYHA1817)