Clinical Trials

A completed Phase 2 clinical trial sponsored by Eli Lilly and Company evaluated the therapeutic application of Etalocib (LY293111) in patients diagnosed with non-small-cell lung carcinoma. The study assessed the efficacy and safety of integrating distinct dosage levels of LY293111 into a chemotherapy regimen of gemcitabine and cisplatin versus a placebo control. Overall, the clinical evaluation of Etalocib highlights industry-sponsored, mid-stage research aimed at enhancing chemotherapeutic outcomes in lung cancer management.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00069875 Completed
Carcinoma Non-Small-Cell Lung
Eli Lilly and Company
 2003-09 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Etalocib competitively binds to the leukotriene B4 receptor (LTB4R), effectively blocking LTB4-mediated signal transduction pathways and inhibiting human neutrophil activation and chemotaxis. By suppressing pro-inflammatory neutrophil infiltration and associated signaling within the tumor microenvironment, this targeted receptor antagonism aims to diminish tumor progression and enhance treatment responsiveness in non-small-cell lung carcinoma.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.