Clinical Trials

Numerous clinical trials evaluate the efficacy, safety, and pharmacokinetics of alectinib across diverse oncology indications, primarily ALK-positive non-small cell lung cancer, brain metastases, ALK fusion-positive solid or central nervous system tumors, neuroblastoma, and lymphoma. Spanning Phase 1 through Phase 4, these studies investigate various clinical scenarios—such as radiotherapy timing and pediatric applications—with recruitment statuses ranging from actively enrolling to completed. These investigations are sponsored by major pharmaceutical companies, including Hoffmann-La Roche and Genentech, as well as multi-center academic institutions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05725200 RECRUITING
Metastatic Colorectal Cancer
Oslo University Hospital
 2022-09-27 PHASE2
NCT04589845 ACTIVE_NOT_RECRUITING
Solid Tumors
Hoffmann-La Roche
 2021-01-18 PHASE2
NCT04774718 ACTIVE_NOT_RECRUITING
ALK Fusion-positive Solid or CNS Tumors
Hoffmann-La Roche
 2021-09-14 PHASE1; PHASE2
NCT07001384 RECRUITING
Anaplastic Lymphoma Kinase; Anaplastic Large Cell Lymphoma
Memorial Sloan Kettering Cancer Center
 2025-08-08 PHASE1
NCT05170204 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2022-11-01 PHASE3
NCT07573696 NOT_YET_RECRUITING
Nonsmall Cell Lung Cancer Stage III
Wen-zhao ZHONG
 2026-06-15 PHASE2
NCT06765109 RECRUITING
Non-small Cell Lung Cancer; Anaplastic Lymphoma Kinase-positive
Nuvalent Inc.
 2025-07-17 PHASE3
NCT05722886 RECRUITING
Haematological Malignancy; Solid Tumour
Cancer Research UK
 2023-03-01 PHASE2; PHASE3
NCT05770037 RECRUITING
Haematological Malignancy; Malignant Neoplasm; Lymphoproliferative Disorders; Neoplasms by Histologic Type; Neoplasms by Site; Cancer; Anaplastic Large Cell Lymphoma; Lymphoma; Renal Cell Carcinoma; Neuroblastoma; Solid Tumour
Cancer Research UK
 2023-12-18 PHASE2; PHASE3
NCT04341181 RECRUITING
Cancer; Tumors; Neoplasms; Neoplasia
Ulrik Lassen
 2020-08-24 PHASE2
NCT07560410 NOT_YET_RECRUITING
Bone Cancer
China Medical University Hospital
 2026-05-15 PHASE1; PHASE2
NCT03202940 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer
Massachusetts General Hospital
 2017-09-14 PHASE1; PHASE2
NCT06709274 NOT_YET_RECRUITING
Non-Small Cell Lung Cancer
Guangdong Association of Clinical Trials
 2024-11
NCT03768063 ACTIVE_NOT_RECRUITING
Cancer
Hoffmann-La Roche
 2019-02-28 PHASE3
NCT05987644 RECRUITING
Lung Cancer; NSCLC; Brain Metastases
Joshua Palmer
 2024-03-07 PHASE1; PHASE2
NCT06692491 NOT_YET_RECRUITING
Rare Tumour
Peking University Shenzhen Hospital
 2025-01-01 PHASE2
NCT02925234 RECRUITING
Cancer; Tumors; Neoplasm; Neoplasia
The Netherlands Cancer Institute
 2016-08 PHASE2
NCT03178552 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2017-09-22 PHASE2; PHASE3
NCT04322890 RECRUITING
Non Small Cell Lung Cancer; EGFR Gene Mutation; ALK Gene Mutation; ROS1 Gene Mutation; MET Gene Mutation
Hunan Province Tumor Hospital
 2020-04-16 PHASE2
NCT05713006 RECRUITING
Non-small Cell Lung Cancer Stage IIIB; ALK Gene Mutation
Instituto Nacional de Cancerologia de Mexico
 2022-05-01 PHASE1; PHASE2
NCT04302025 RECRUITING
Non-small Cell Lung Cancer
Genentech, Inc.
 2020-11-06 PHASE2
NCT05159245 RECRUITING
Advanced Cancer; Solid Tumor; Haematological Malignancy
Helsinki University Central Hospital
 2021-12-10 PHASE2
NCT05987956 ACTIVE_NOT_RECRUITING
ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair
 2026-03-18 PHASE2; PHASE3
NCT05266846 RECRUITING
ALK Gene Mutation; Lung Adenocarcinoma; Immunotherapy
Hunan Province Tumor Hospital
 2024-05-29 PHASE2
NCT04116541 RECRUITING
Malignant Solid Tumor
Centre Leon Berard
 2020-01-28 PHASE2
NCT06624059 COMPLETED
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2024-11-18 PHASE3
NCT04423185 RECRUITING
Rare Tumor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2020-08-15 PHASE2
NCT05238831 WITHDRAWN
Advanced Breast Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Ovarian Carcinoma; Advanced Pancreatic Carcinoma; Advanced Prostate Carcinoma; Advanced Sarcoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Recurrent Adult Soft Tissue Sarcoma; Recurrent Breast Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Prostate Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8
OHSU Knight Cancer Institute
 2023-01-30 EARLY_PHASE1
NCT06354387 COMPLETED
Hepatocellular Carcinoma
China Medical University Hospital
 2022-02-16 PHASE1
NCT05525338 RECRUITING
Drug Monitoring; Carcinoma, Non-Small-Cell Lung; Lung Cancer; Anaplastic Lymphoma Kinase Gene Mutation; Anaplastic Lymphoma Kinase Gene Translocation
University Medical Center Groningen
 2022-03-23 PHASE4
NCT05296278 UNKNOWN
Non Small Cell Lung Cancer
Hunan Province Tumor Hospital
 2023-12-25 PHASE2
NCT02314481 COMPLETED
Non-small Cell Lung Cancer
University College, London
 2017-05-12 PHASE2
NCT03194893 COMPLETED
Neoplasms
Hoffmann-La Roche
 2017-07-05 PHASE3
NCT03944772 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
AstraZeneca
 2019-06-25 PHASE2
NCT04551521 COMPLETED
Metastatic or Locally Advanced Malignancies
German Cancer Research Center
 2021-10-13 PHASE2
NCT05015010 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer
Gruppo Oncologico Italiano di Ricerca Clinica
 2021-05-20 PHASE2
NCT04591431 UNKNOWN
Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer
Fondazione per la Medicina Personalizzata
 2020-10-07 PHASE2
NCT05710133 COMPLETED
NSCLC
The Netherlands Cancer Institute
 2024-02-01
NCT05724004 RECRUITING
Radiotherapy Side Effect; Non-small Cell Lung Cancer; ALK Gene Mutation
Karolinska University Hospital
 2023-10-05
NCT05987956 Not yet recruiting
Non-small Cell Lung Cancer
Han Xu M.D. Ph.D. FAPCR Sponsor-Investigator IRB Chair|Medicine Invention Design Inc
 2024-03-08 Phase 2|Phase 3
NCT05987644 Recruiting
Lung Cancer|NSCLC|Brain Metastases
Joshua Palmer|Genentech Inc.|Hoosier Cancer Research Network
 2024-03-07 Phase 1|Phase 2
NCT03596866 COMPLETED
ALK+ Advanced NSCLC
Takeda
 2019-04-19 PHASE3
NCT05710133 Enrolling by invitation
NSCLC
The Netherlands Cancer Institute
 2024-02-01 Not Applicable
NCT04997382 COMPLETED
Non-small Cell Lung Cancer
Hunan Province Tumor Hospital
 2021-08-17 PHASE2
NCT04632992 COMPLETED
Advanced Unresectable or Metastatic Solid Malignancy
Genentech, Inc.
 2021-01-13 PHASE2
NCT05770037 Recruiting
Solid Tumor|Haematological Malignancy|Malignant Neoplasm|Lymphoproliferative Disorders|Neoplasms by Histologic Type|Neoplasms by Site|Cancer|Anaplastic Large Cell Lymphoma|Lymphoma|Renal Cell Carcinoma|Neuroblastoma
Cancer Research UK|University of Manchester|University of Birmingham|Royal Marsden NHS Foundation Trust|Hoffmann-La Roche
 2023-12-18 Phase 2|Phase 3
NCT05081674 COMPLETED
Lung Neoplasm
Hospital Israelita Albert Einstein
 2020-01-01 PHASE2
NCT03456076 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Hoffmann-La Roche
 2018-08-16 PHASE3
NCT02091141 COMPLETED
Neoplasms; Solid Tumors; Biliary Cancer; Salivary Cancer; Bladder Cancer
Genentech, Inc.
 2014-04-14 PHASE2
NCT03158389 COMPLETED
Glioblastoma, Adult
University Hospital Heidelberg
 2018-05-07 PHASE1; PHASE2
NCT03498521 COMPLETED
Cancer of Unknown Primary Site
Hoffmann-La Roche
 2018-07-10 PHASE2
NCT03779191 COMPLETED
ALK Gene Rearrangement Positive; Non-Squamous Non-Small Cell Neoplasm of Lung
Instituto Nacional de Cancerologia de Mexico
 2020-04-08 PHASE2
NCT04644315 TERMINATED
Neoplasms; Colorectal Neoplasms; Melanoma; Pancreatic Neoplasms; Sarcoma; Ovarian Neoplasms; Brain Neoplasms; Thyroid Neoplasms; Neuroendocrine Tumors; Cholangiocarcinoma; Salivary Gland Neoplasms; Head and Neck Neoplasms; Thyroid Cancer, Papillary; Lymphoma, Large-Cell, Anaplastic; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Central Nervous System
Hoffmann-La Roche
 2021-05-24 PHASE2
NCT02521051 TERMINATED
Non-Small Cell Lung Cancer (NSCLC)
Massachusetts General Hospital
 2015-09-28 PHASE1; PHASE2
NCT05525338 Recruiting
Drug Monitoring|Carcinoma Non-Small-Cell Lung|Lung Cancer|Anaplastic Lymphoma Kinase Gene Mutation|Anaplastic Lymphoma Kinase Gene Translocation
University Medical Center Groningen|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|Erasmus Medical Center|Maastricht University Medical Center|Radboud University Medical Center|The Netherlands Cancer Institute|Leiden University Medical Center
 2022-03-23 Phase 4
NCT04774718 Recruiting
ALK Fusion-positive Solid or CNS Tumors
Hoffmann-La Roche
 2021-09-14 Phase 1|Phase 2
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
NCT03445000 TERMINATED
Non-small Cell Lung Cancer; Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Recurrent
ETOP IBCSG Partners Foundation
 2018-11-06 PHASE2
NCT03535740 COMPLETED
ALK-positive Advanced NSCLC
Ariad Pharmaceuticals
 2019-01-31 PHASE2
NCT02013219 COMPLETED
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2014-04-03 PHASE1
NCT03155009 COMPLETED
Carcinoma, Non-Small-Cell Lung
Hoffmann-La Roche
 2017-07-10 PHASE2
NCT03131206 TERMINATED
ALK-positive Non-small Cell Lung Cancer (NSCLC); RET-positive Non-small Cell Lung Cancer (NSCLC); RET-positive Thyroid Cancer
Dana-Farber Cancer Institute
 2017-06-19 PHASE1; PHASE2
NCT02838420 COMPLETED
Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer
Hoffmann-La Roche
 2016-08-03 PHASE3
NCT02450903 COMPLETED
Non-Small-Cell Lung Cancer
Novartis Pharmaceuticals
 2015-08-21 PHASE2
NCT02075840 COMPLETED
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2014-08-19 PHASE3
NCT02604342 COMPLETED
Non-small Cell Lung Cancer
Hoffmann-La Roche
 2015-11-03 PHASE3
NCT02621047 COMPLETED
Hepatic Impairment
Hoffmann-La Roche
 2015-12-04 PHASE1
NCT01801111 COMPLETED
Non-Small-Cell Lung Carcinoma
Hoffmann-La Roche
 2013-06-20 PHASE1; PHASE2
NCT01871805 COMPLETED
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2013-09-30 PHASE1; PHASE2
NCT01984229 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2013-12 PHASE1
NCT02023125 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2013-12 PHASE1

(data from https://clinicaltrials.gov, updated on 2023-02-21)

Check the Alectinib (CH5424802) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alectinib selectively binds to the ATP-binding site of anaplastic lymphoma kinase, including the gatekeeper L1196M mutant, which blocks receptor autophosphorylation and suppresses downstream STAT3 and AKT signaling pathways to inhibit cellular proliferation in ALK-dependent malignancies. This targeted inhibition directly underlies its therapeutic relevance in clinical trials for ALK-positive non-small cell lung cancer, central nervous system metastases, and ALK fusion-positive 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>).

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