Zorifertinib (AZD3759) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials evaluate Zorifertinib (AZD3759) across Phase 1, Phase 2, and Phase 3 investigations, focusing predominantly on patients with EGFR mutation-positive advanced non-small cell lung cancer presenting with central nervous system or leptomeningeal metastases. Sponsored by industry leaders such as AstraZeneca and Alpha Biopharma alongside academic institutions like the Chinese Academy of Medical Sciences, these studies evaluate safety, pharmacokinetics, and therapeutic efficacy in both monotherapy and combination settings. Protocol recruitment statuses range from completed to actively recruiting or pending trials targeting disease progression after prior EGFR tyrosine kinase inhibitor therapies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07361705	RECRUITING	Patients With Advanced Non-small Cell Lung Cancer With Meningeal Progression After Osimertinib Treatment	Alpha Biopharma (Jiangsu) Co., Ltd.	2026-01-31	PHASE1
NCT07551414	NOT_YET_RECRUITING	NSCLC (Non-small Cell Lung Carcinoma); Leptomeningeal Metastasis; EGFR-TKI Sensitizing Mutation; Zorifertinib	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	2026-05-30	PHASE2
NCT07620951	RECRUITING	EGFR Mutant Advanced Non-small Cell Lung Cancer; Central Nervous System (CNS) Metastases	Alpha Biopharma (Jiangsu) Co., Ltd.	2026-07-06	PHASE1
NCT03574402	UNKNOWN	Carcinoma, Non-Small-Cell Lung	Guangdong Association of Clinical Trials	2018-07-09	PHASE2
NCT03653546	COMPLETED	Non-small Cell Lung Cancer; EGFR Gene Mutation; Brain Metastases	Alpha Biopharma (Jiangsu) Co., Ltd.	2018-10-29	PHASE2; PHASE3
NCT03360929	COMPLETED	Non Small Cell Lung Cancer	LYZZ Alpha Holding Ltd	2017-10-30	PHASE1; PHASE2
NCT02228369	COMPLETED	EGFR Mutation Positive Advanced Non Small Cell Lung Cancer	AstraZeneca	2014-11-05	PHASE1
NCT02228369	Completed	EGFR Mutation Positive Advanced Non Small Cell Lung Cancer	AstraZeneca	2014-11-05	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-22)

Check the Zorifertinib (AZD3759) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zorifertinib (AZD3759) is a potent, central nervous system-penetrant small-molecule inhibitor that selectively binds to both wild-type and mutant epidermal growth factor receptor (EGFR) tyrosine kinases, including the L858R and exon 19 deletion variants. This targeted binding blocks receptor autophosphorylation and suppresses downstream oncogenic signaling pathways, thereby inhibiting tumor cell proliferation and driving apoptosis in EGFR-mutant advanced non-small cell lung cancer with brain and leptomeningeal metastases.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).