Nazartinib (EGF816) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 have evaluated nazartinib (EGF816) as monotherapy and combination regimens for EGFR-mutated non-small cell lung cancer, advanced solid tumors, melanoma, and gastrointestinal stromal tumors. Sponsored by major pharmaceutical entities such as Novartis alongside academic medical centers, these studies encompass completed, active not recruiting, terminated, and withdrawn protocols. This includes a clinical trial evaluating nazartinib against standard EGFR inhibitors in first-line settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03040973	ACTIVE_NOT_RECRUITING	Advanced Solid Tumors Which Are cMET-dependent	Novartis Pharmaceuticals	2017-08-23	PHASE2
NCT03333343	ACTIVE_NOT_RECRUITING	EGFR-mutant Non-small Cell Lung Cancer	Novartis Pharmaceuticals	2018-01-29	PHASE1
NCT03114319	TERMINATED	Advanced EGFR Mutant Non Small Cell LungCancer (NSCLC); KRAS G12-mutant NSCLC; Esophageal Squamous Cell Cancer (SCC); Head/Neck SCC; Melanoma; Advanced Gastrointestinal Stromal Tumors (GIST); Advanced NRAS/BRAFT wt Cutaneous Melanoma	Novartis Pharmaceuticals	2017-05-26	PHASE1
NCT03516214	COMPLETED	Bronchial Neoplasms	University of Cologne	2018-04-25	PHASE1
NCT03292133	TERMINATED	Lung Cancer	Massachusetts General Hospital	2017-10-31	PHASE2
NCT02900664	COMPLETED	Colorectal Cancer, Triple Negative Breast Cancer, NSCLC - Adenocarcinoma	Novartis Pharmaceuticals	2016-08-23	PHASE1
NCT02335944	TERMINATED	Non Small Cell Lung Cancer	Novartis Pharmaceuticals	2015-01-13	PHASE1; PHASE2
NCT03529084	WITHDRAWN	Carcinoma, Non-small Cell Lung	Novartis Pharmaceuticals	2018-07-24	PHASE3
NCT02323126	TERMINATED	Non Small Cell Lung Cancer	Novartis Pharmaceuticals	2015-02-09	PHASE2
NCT03529084	Withdrawn	Carcinoma Non-small Cell Lung	Novartis Pharmaceuticals\|Novartis	2018-07-24	Phase 3
NCT03516214	Completed	Bronchial Neoplasms	University of Cologne	2018-04-25	Phase 1
NCT02108964	COMPLETED	Advanced Non-small Cell Lung Cancer	Novartis Pharmaceuticals	2014-06-06	PHASE1; PHASE2
NCT03292133	Active not recruiting	Lung Cancer	Massachusetts General Hospital\|Novartis	2017-10-31	Phase 2
NCT02323126	Terminated	Non Small Cell Lung Cancer	Novartis Pharmaceuticals\|Novartis	2015-02-09	Phase 2
NCT02335944	Terminated	Non Small Cell Lung Cancer	Novartis Pharmaceuticals\|Novartis	2015-01-13	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-06-11)

Check the Nazartinib (EGF816) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nazartinib functions as a covalent, irreversible inhibitor that selectively targets mutated epidermal growth factor receptor (EGFR), specifically inhibiting T790M and activating mutations to block downstream intracellular signal transduction and suppress cancer cell proliferation. This targeted inhibition directly halts tumor expansion in patients with EGFR-mutant non-small cell lung cancer and other advanced solid malignancies evaluated in clinical studies.

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>).