We also explored clinical phosEGFR reduction induced by the 3rd generation TKI osimertinib, suggesting that limited target engagement may explain modest response achieved in EGFR Exon20Ins at the clinically investigated doses. The developed model is a valuable tool to understand the impact of kinetic characteristics on phosEGFR reduction and related efficacy, select a target engagement-based criterion for therapeutic dose predictions, and provide interpretation and insights on observed clinical efficacy of irreversible inhibitors in EGFR Exon20Ins.

2 days ago

PK/PD data • Preclinical • Journal

EGFR (Epidermal growth factor receptor)

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

Tagrisso (osimertinib) • simmitinib (SYHA1817)

Therapeutic Impact of Third-generation Tyrosine Kinase Inhibitors on Lung Squamous Cell Carcinoma with Epidermal Growth Factor Receptor Mutations: A Case Description and Systematic Literature Review. (PubMed, Intern Med)

The efficacy of TKIs was consistent across SQC forms (including de novo or adenocarcinoma-transformed cases) and EGFR mutation types. The findings indicate that, compared with early-generation TKIs, third-generation TKIs are effective against de novo SQCs and should be considered a plausible treatment option for transformed SQCs.

2 days ago

Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation

Tagrisso (osimertinib) • simmitinib (SYHA1817)

TATTON: AZD9291 in Combination With Ascending Doses of Novel Therapeutics (clinicaltrials.gov)

P1, N=344, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Dec 2026

3 days ago

Trial completion date

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

Tagrisso (osimertinib) • Imfinzi (durvalumab) • Koselugo (selumetinib) • Orpathys (savolitinib) • simmitinib (SYHA1817)

Local Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer (clinicaltrials.gov)

P2, N=64, Not yet recruiting, Chinese University of Hong Kong

3 days ago

New P2 trial

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR positive

Tagrisso (osimertinib) • simmitinib (SYHA1817)

Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib. (clinicaltrials.gov)

P2, N=36, Recruiting, Guangzhou Medical University | Not yet recruiting --> Recruiting | Trial completion date: Mar 2026 --> Mar 2027

3 days ago

Enrollment open • Trial completion date

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion

Tagrisso (osimertinib) • pemetrexed • simmitinib (SYHA1817)

First Line and Treatment Sequencing in EGFR-Mutated Metastatic NSCLC: What is Right for Which Patient? (PubMed, Drugs)

For classical EGFR mutations such as exon 19 deletion and exon 21 L858R mutation, combination strategies in the first-line setting, based on the results of the MARIPOSA (lazertinib and amivantamab) and FLAURA 2 (platinum-based doublet chemotherapy and osimertinib) trials, provide promising outcomes. Optimising the treatment sequence in advanced EGFR-mutated NSCLC is crucial to ensure the best survival outcomes along with the best treatment tolerance and quality of life. Predictive biomarkers are strongly needed as well as biomarker-based escalation and de-escalation clinical trials.

4 days ago

Review • Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L858R + EGFR exon 19 deletion

Tagrisso (osimertinib) • Lazcluze (lazertinib) • simmitinib (SYHA1817)

Study on the resistance mechanism of ANGPTL4 mediated by NF-Kb/HIF-1 α to osimertinib in non-small cell lung cancer (ChiCTR2600117670)

P=N/A, N=8, Not yet recruiting, Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital); Guangdong Second Provincial General Hospital (Guangdong Provin

4 days ago

New trial

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion

Tagrisso (osimertinib) • simmitinib (SYHA1817)

Clinical Characteristics of Osimertinib-Related Cardiac Toxicity (ChiCTR2600117457)

P=N/A, N=80, Not yet recruiting, The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University

4 days ago

New trial

Tagrisso (osimertinib) • simmitinib (SYHA1817)

Exploration of the Efficacy and Safety of metronomic chemotherapy with vinorelbine capsules combined with third-generation EGFR-TKI as First-Line Treatment in Elderly Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutations (ChiCTR2500115674)

P=N/A, N=66, Not yet recruiting, Beijing hospital; Beijing hospital

4 days ago

New trial

EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion

Tagrisso (osimertinib) • Ameile (aumolertinib) • vinorelbine tartrate • Ivesa (firmonertinib) • simmitinib (SYHA1817)

The Study on the Mechanism of Osimertinib-induced Pulmonary Toxicity through Up-regulating TRAPPC9 in Lung Epithelial Cells to Activate Secretory Autophagy and Recruit Macrophages (ChiCTR2500115251)

P=N/A, N=100, Not yet recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

4 days ago

New trial

Tagrisso (osimertinib) • simmitinib (SYHA1817)

The resistance mechanism and genetic profile of EGFRm advanced NSCLC patients who had disease progression on 1st line Osimertinib plus chemotherapy(SURPASS study) (ChiCTR2500113266)

P=N/A, N=100, Not yet recruiting, Shanghai Gobroad Cancer Hospital; Shanghai Gobroad Cancer Hospital

4 days ago

New trial

EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion

Tagrisso (osimertinib) • simmitinib (SYHA1817)

Adjuvant icotinib and osimertinib in the treatment of EGFR-mutated resectable non-small cell lung cancer: A real-world multicenter cohort study in China (ChiCTR2500112843)

P=N/A, N=200, Not yet recruiting, Beijing Chest Hospital Capital Medical University; Beijing Chest Hospital Capital Medical University

4 days ago

New trial

EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)

TP53 mutation • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR S768I

Tagrisso (osimertinib) • Conmana (icotinib) • simmitinib (SYHA1817)