AZ5104 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 397

Clinical Trials

Multiple clinical trials evaluate therapies for non-small cell lung cancer across Phase 2, Phase 3, and Phase 4, investigating combination treatment regimens, adjuvant therapy, and pharmacokinetic boosting, respectively. Sponsored by academic institutions like Maastricht University Medical Center and pharmaceutical leaders such as AstraZeneca, these studies currently maintain recruiting or active, non-recruiting statuses. Together, these clinical investigations aim to optimize therapeutic strategies and improve patient outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05748093	Recruiting	Non-small Cell Lung Cancer	Maastricht University Medical Center	2024-04-01	Phase 4
NCT05120349	Recruiting	Non-Small Cell Lung Cancer	AstraZeneca	2022-02-21	Phase 3
NCT04606771	Active not recruiting	Non-Small Cell Lung Cancer	AstraZeneca	2020-09-28	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the AZ5104 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZ5104 potently and selectively binds to wild-type and mutant forms of epidermal growth factor receptor (EGFR), including the L858R/T790M, L858R, and L861Q variants, thereby blocking downstream receptor autophosphorylation and signaling cascades necessary for cellular survival. By suppressing these oncogenic driver pathways, the compound inhibits tumor cell proliferation, providing a mechanistically targeted strategy directly relevant to clinical trials investigating non-small cell lung cancer.

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>).