Clinical Trials

Multiple clinical trials sponsored by Nuvalent Inc. are currently evaluating NVL-655 (neladalkib) in patients with locally advanced solid tumors, metastatic solid tumors, and ALK-positive non-small cell lung cancer (NSCLC). Spanning Phase 1, Phase 2, and Phase 3 evaluations alongside expanded access protocols, active recruitment is ongoing for studies including a Phase 1/2 trial and a Phase 3 comparative study against alectinib. Additionally, expanded access treatment options remain available for eligible patients.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06765109 RECRUITING
Non-small Cell Lung Cancer; Anaplastic Lymphoma Kinase-positive
Nuvalent Inc.
 2025-07-17 PHASE3
NCT05384626 RECRUITING
Locally Advanced Solid Tumor; Metastatic Solid Tumor
Nuvalent Inc.
 2022-06-09 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-25)

Check the NVL-655 (Neladalkib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

NVL-655 (Neladalkib) selectively binds to and inhibits anaplastic lymphoma kinase (ALK), including key resistance mutations such as G1202R, thereby blocking downstream oncogenic signaling pathways and inhibiting tumor cell proliferation. This targeted inhibition suppresses tumor growth, providing therapeutic relevance for treating ALK-positive non-small cell lung cancer and advanced solid tumors.

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.