Lorlatinib (PF-6463922) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 570

Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate lorlatinib across monotherapy and combination regimens for advanced or metastatic ALK- or ROS1-rearranged non-small cell lung cancer, relapsed neuroblastoma, and central nervous system progression. Additional studies assess drug-drug interactions and pharmacokinetics in healthy volunteers and individuals with hepatic impairment. Sponsored by pharmaceutical companies, academic institutions, and oncology consortia, these studies encompass various recruitment statuses, including recruiting, active, and completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03126916	RECRUITING	Ganglioneuroblastoma; Ganglioneuroblastoma, Nodular; Neuroblastoma	Children's Oncology Group	2018-05-14	PHASE3
NCT07617337	RECRUITING	ALK Positive Non-small Cell Lung Cancer	Chugai Pharmaceutical	2026-07-24	PHASE1
NCT07782359	NOT_YET_RECRUITING	Lung Cancer	University of Chicago	2026-10	PHASE1
NCT06858410	NOT_YET_RECRUITING	Neoadjuvant Non-Small Cell Lung Cancer	Guangdong Association of Clinical Trials	2025-03	PHASE3
NCT07750704	NOT_YET_RECRUITING	ALK Positive Non-small Cell Lung Cancer	Guangdong Association of Clinical Trials	2026-09	PHASE2
NCT06333899	RECRUITING	High Grade Glioma; Diffuse Intrinsic Pontine Glioma; Anaplastic Astrocytoma; Infant Type Hemispheric Glioma; Glioblastoma; Glioblastoma Multiforme; WHO Grade III Glioma; WHO Grade IV Glioma; Diffuse Midline Glioma, H3K27-altered	Nationwide Children's Hospital	2025-08-03	EARLY_PHASE1
NCT07671560	NOT_YET_RECRUITING	ALK-positive, Locally Advanced or Metastatic (TNM Stage IIIB-IV) Non-small Cell Lung Cancer That Has Developed Resistance to Prior Treatment With Lorlatinib	Qiming Wang	2026-07-01	PHASE4
NCT06487078	RECRUITING	ALK+ Non-Small-Cell Lung Carcinoma	Pfizer	2025-01-20
NCT06007937	ACTIVE_NOT_RECRUITING	Non Small Cell Lung Cancer; Metastatic; Recurrent	Memorial Sloan Kettering Cancer Center	2023-08-17	PHASE1; PHASE2
NCT07415005	RECRUITING	Advanced Non-Small Cell Lung Cancer	M.D. Anderson Cancer Center	2026-04-24	PHASE2
NCT07674368	NOT_YET_RECRUITING	ALK Fusion-positive Non-small Cell Lung Cancer	Hunan Cancer Hospital	2026-07-10	PHASE4
NCT06378892	RECRUITING	Non Small Cell Lung Cancer Metastatic; ALK Gene Mutation	Centro di Riferimento Oncologico - Aviano	2024-03-15	PHASE2
NCT02925234	RECRUITING	Cancer; Tumors; Neoplasm; Neoplasia	The Netherlands Cancer Institute	2016-08	PHASE2
NCT07784959	RECRUITING	ALK Positive; ALK Positive Non-small Cell Lung Cancer; NSCLC; ALK+ Non-Small-Cell Lung Carcinoma	Nuvectis Pharma, Inc.	2026-08-17	PHASE1
NCT06893354	NOT_YET_RECRUITING	NSCLC	The First Affiliated Hospital of Guangzhou Medical University	2025-05-10	PHASE4
NCT07083687	NOT_YET_RECRUITING	Lung Cancer (NSCLC)	Hunan Cancer Hospital	2025-08-15	PHASE2
NCT05144997	ACTIVE_NOT_RECRUITING	Non-Small-Cell Lung Cancer; NSCLC	Pfizer	2021-12-28	PHASE4
NCT06282874	ACTIVE_NOT_RECRUITING	Carcinoma, Non-Small-Cell Lung; Brain Metastases; Leptomeningeal Metastasis	Guangdong Association of Clinical Trials	2024-08-01	PHASE4
NCT06682884	NOT_YET_RECRUITING	Neoadjuvant Non-Small Cell Lung Cancer	Peking University People's Hospital	2024-11-15	PHASE2
NCT03505554	COMPLETED	Anaplastic Large Cell Lymphoma, ALK-Positive	University of Milano Bicocca	2019-09-28	PHASE2
NCT05740943	ACTIVE_NOT_RECRUITING	Stage III NSCLC; Surgery	Guangdong Provincial People's Hospital	2023-03-15	PHASE2
NCT06092086	RECRUITING	ALK Positive Non-small Cell Lung Cancer	Guangdong Association of Clinical Trials	2023-08-18	PHASE2
NCT05948462	WITHDRAWN	Lung Cancer; Non-small Cell Lung Cancer	SCRI Development Innovations, LLC	2023-11	PHASE2
NCT04621188	ACTIVE_NOT_RECRUITING	Non Small Cell Lung Cancer Metastatic	Intergroupe Francophone de Cancerologie Thoracique	2021-03-19	PHASE2
NCT03107988	COMPLETED	Neuroblastoma	New Approaches to Neuroblastoma Therapy Consortium	2017-09-05	PHASE1
NCT05224609	COMPLETED	Moderate Hepatic Impairment; Severe Hepatic Impairment; Healthy Volunteers	Pfizer	2022-04-28	PHASE1
NCT04127110	ACTIVE_NOT_RECRUITING	Non Small Cell Lung Cancer	European Organisation for Research and Treatment of Cancer - EORTC	2020-11-17	PHASE2
NCT04800822	TERMINATED	Solid Tumor	Pfizer	2021-03-17	PHASE1
NCT05097599	TERMINATED	Cancer; Advanced Solid Tumor	Strata Oncology	2022-04-29	PHASE2
NCT04362072	COMPLETED	Carcinoma; Non-Small-Cell Lung	Pfizer	2020-09-29	PHASE4
NCT06378892	Recruiting	Non Small Cell Lung Cancer Metastatic\|ALK Gene Mutation	Centro di Riferimento Oncologico - Aviano	2024-03-15	Phase 2
NCT05297890	ACTIVE_NOT_RECRUITING	Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer	CStone Pharmaceuticals	2022-05-27	PHASE2
NCT06092086	Recruiting	ALK Positive Non-small Cell Lung Cancer	Guangdong Association of Clinical Trials	2023-08-18	Phase 2
NCT03612154	UNKNOWN	Nonsmall Cell Lung Cancer	National Cancer Center, Korea	2019-05-02	PHASE2
NCT04292119	UNKNOWN	Lung Cancer; Anaplastic Lymphoma Kinase Gene Translocation; ROS1 Rearrangement; Relapsed Cancer; MET Amplification; Resistant Cancer; NSCLC	Massachusetts General Hospital	2020-05-01	PHASE1; PHASE2
NCT04111705	COMPLETED	Non Small Cell Lung Cancer Metastatic	Intergroupe Francophone de Cancerologie Thoracique	2020-08-05	PHASE2
NCT04541706	COMPLETED	Advanced Non-Small Cell Lung Cancer	Pfizer	2020-08-27	PHASE4
NCT03439215	UNKNOWN	Carcinoma, Non-Small-Cell Lung	Fondazione Ricerca Traslazionale	2017-06-13	PHASE2
NCT05297890	Active not recruiting	Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer	CStone Pharmaceuticals\|Pfizer	2022-05-27	Phase 2
NCT04541407	COMPLETED	Non Small Cell Lung Cancer; CNS Progression	University of Colorado, Denver	2020-10-29	PHASE1
NCT05224609	Recruiting	Moderate Hepatic Impairment\|Severe Hepatic Impairment\|Healthy Volunteers	Pfizer	2022-04-28	Phase 1
NCT02927340	UNKNOWN	Non-Small Cell Lung Cancer (NSCLC)	Massachusetts General Hospital	2016-10	PHASE2
NCT03737994	TERMINATED	Lung Non-Squamous Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	National Cancer Institute (NCI)	2019-07-25	PHASE2
NCT03726333	TERMINATED	Advanced Cancers	Pfizer	2020-01-14	PHASE1
NCT03878524	TERMINATED	Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma	OHSU Knight Cancer Institute	2020-04-01	PHASE1
NCT03909971	COMPLETED	Carcinoma, Non-Small-Cell Lung	Pfizer	2019-04-28	PHASE2
NCT03052608	ACTIVE_NOT_RECRUITING	Carcinoma, Non-Small-Cell Lung	Pfizer	2017-04-27	PHASE3
NCT03542305	COMPLETED	Renal Impairment	Pfizer	2018-08-23	PHASE1
NCT03961997	COMPLETED	Adult; Drug Interactions; Healthy Volunteers; Humans	Pfizer	2019-08-22	PHASE1
NCT03184168	COMPLETED	Healthy Volunteers	Pfizer	2017-07-05	PHASE1

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

Check the Lorlatinib (PF-6463922) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lorlatinib selectively binds to the ATP-binding sites of wild-type and mutant ALK and ROS1 receptor tyrosine kinases, preventing their autophosphorylation and suppressing downstream oncogenic signaling cascades. This inhibition induces cell cycle arrest and apoptosis in transformed cells, which directly mediates tumor regression in patients with ALK-positive or ROS1-rearranged 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>).