Alectinib

Generic Name: Alectinib

Brand Names: Alecensa, Alecensaro

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₃₄N_₄O_₂

CAS Number: 1256580-46-7

Unique Ingredient Identifier: LIJ4CT1Z3Y

Background: Alectinib is a second generation oral drug that selectively inhibits the activity of anaplastic lymphoma kinase (ALK) tyrosine kinase. It is specifically used in the treatment of non-small cell lung cancer (NSCLC) expressing the ALK-EML4 (echinoderm microtubule-associated protein-like 4) fusion protein that causes proliferation of NSCLC cells. Inhibition of ALK prevents phosphorylation and subsequent downstream activation of STAT3 and AKT resulting in reduced tumour cell viability.

Approved under accelerated approval in 2015, alectinib is indicated for use in patients who have progressed on or were not tolerant of crizotinib, which is associated with the development of resistance.

Indication: Alectinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Associated Conditions: Refractory, metastatic Non small cell lung cancer

Clinical Trials

Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Lung Non-Squamous Non-Small Cell Carcinoma

Interventions: Drug: Crizotinib
Drug: Alectinib
Drug: Brigatinib
Drug: Ceritinib
Drug: Lorlatinib
Drug: Carboplatin
Drug: Ensartinib
Drug: Cisplatin
Drug: Pemetrexed

First Posted Date: 2018-11-13

Last Posted Date: 2025-05-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 10

Registration Number: NCT03737994

Locations: 🇺🇸
Macomb Hematology Oncology PC, Warren, Michigan, United States
🇺🇸
Kaiser Permanente-Richmond, Richmond, California, United States
🇺🇸
Carle Cancer Center, Urbana, Illinois, United States

and more 486 locations

A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

Phase 3

Completed

Conditions: ALK+ Advanced NSCLC

Interventions: Drug: Brigatinib
Drug: Alectinib

First Posted Date: 2018-07-24

Last Posted Date: 2025-03-25

Lead Sponsor: Takeda

Target Recruit Count: 248

Registration Number: NCT03596866

Locations: 🇦🇷
Sanatorio Duarte Quiros, Cordoba, Argentina
🇨🇳
Peking Union Medical College Hospital - East, Beijing, Beijing, China
🇨🇱
Centro de Investigacion Clinica Bradford Hill, Recoleta, Santiago, Chile

and more 108 locations

A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors

Completed

Conditions: Anaplastic Lymphoma Kinase-positive
Carcinoma Non-small-cell Lung

Interventions: Drug: Brigatinib
Drug: Alectinib
Drug: Ceritinib
Drug: Lorlatinib
Drug: Any FDA Approved ALK Inhibitors

First Posted Date: 2018-06-06

Last Posted Date: 2024-07-15

Lead Sponsor: Takeda

Target Recruit Count: 111

Registration Number: NCT03546894

Locations: 🇺🇸
EmpiraMed, Inc., Maynard, Massachusetts, United States

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

Phase 2

Completed

Conditions: Cancer of Unknown Primary Site

Interventions: Drug: Alectinib
Drug: Vismodegib
Drug: Carboplatin
Drug: Ipatasertib
Drug: Olaparib
Drug: Erlotinib
Drug: Cisplatin
Drug: Bevacizumab
Drug: Gemcitabine
Drug: Vemurafenib
Drug: Cobimetinib
Drug: Trastuzumab Subcutaneous (SC)
Drug: Pertuzumab
Drug: Atezolizumab
Drug: Paclitaxel
Drug: Entrectinib
Drug: Ivosidenib
Drug: Pemigatinib

First Posted Date: 2018-04-13

Last Posted Date: 2025-02-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 528

Registration Number: NCT03498521

Locations: 🇫🇷
Centre Antoine Lacassagne, Nice, France
🇫🇷
Institut Curie, Paris, France
🇫🇷
CHU Lyon - Centre Hospitalier Lyon Sud, Pierre-Benite (Lyon), France

and more 127 locations

ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer

Phase 2

Terminated

Conditions: Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Recurrent

Interventions: Drug: Alectinib

First Posted Date: 2018-02-26

Last Posted Date: 2025-04-08

Lead Sponsor: ETOP IBCSG Partners Foundation

Target Recruit Count: 14

Registration Number: NCT03445000

Locations: 🇳🇱
University Medical Center Maastricht, Maastricht, Netherlands
🇳🇱
The Netherlands Cancer Institute Amsterdam, Amsterdam, Netherlands
🇨🇭
Hôpital Universitaire de Genève, Genève, Switzerland

and more 16 locations

Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Alectinib

First Posted Date: 2017-09-05

Last Posted Date: 2022-11-18

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 355

Registration Number: NCT03271554

Locations: 🇰🇷
Inje University Busan Paik Hospital, Busan, Korea, Republic of
🇰🇷
Dong-A University Hospital, Busan, Korea, Republic of
🇰🇷
Pusan National University Hospital, Busan, Korea, Republic of

and more 33 locations

A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC

Phase 1

Active, not recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Alectinib
Drug: Cobimetinib

First Posted Date: 2017-06-29

Last Posted Date: 2024-04-23

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 16

Registration Number: NCT03202940

Locations: 🇺🇸
Massachusetts general Hospital, Boston, Massachusetts, United States

A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

Phase 3

Active, not recruiting

Conditions: Neoplasms

Interventions: Drug: Alectinib
Drug: Crizotinib

First Posted Date: 2017-06-21

Last Posted Date: 2025-05-11

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 200

Registration Number: NCT03194893

Locations: 🇫🇷
Groupe Hospitalier Sud - Hôpital Haut Lévêque, Pessac, France
🇭🇰
Queen Elizabeth Hospital Department of Clinical Oncology, Kowloon, Hong Kong
🇮🇹
Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1, Roma, Lazio, Italy

and more 26 locations

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Active, not recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Alectinib
Drug: Entrectinib
Drug: Atezolizumab
Drug: Divarasib
Drug: Cisplatin
Drug: Pemetrexed
Drug: Docetaxel
Drug: Cobimetinib
Drug: Gemcitabine
Drug: Carboplatin
Drug: Vemurafenib
Drug: Bevacizumab

First Posted Date: 2017-06-07

Last Posted Date: 2025-05-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1000

Registration Number: NCT03178552

Locations: 🇵🇪
Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru
🇵🇪
Instituto Peruano de Oncología y Radioterapia, Lima, Peru
🇵🇪
Clinica Ricardo Palma, San Isidro, Peru

and more 156 locations

NCT Neuro Master Match - N²M² (NOA-20)

Phase 1

Completed

Conditions: Glioblastoma, Adult

Interventions: Drug: Temsirolimus
Drug: APG101
Drug: Alectinib
Drug: Atezolizumab
Drug: Vismodegib
Drug: Palbociclib
Drug: Idasanutlin

First Posted Date: 2017-05-18

Last Posted Date: 2023-09-28

Lead Sponsor: University Hospital Heidelberg

Target Recruit Count: 228

Registration Number: NCT03158389

Locations: 🇩🇪
University Hospital Mainz, Neurosurgery, Mainz, Germany
🇩🇪
University Hospital Heidelberg, Neurology Clinic, Heidelberg, Germany
🇩🇪
University Hospital Frankfurt, Neurooncology, Frankfurt am Main, Germany

and more 10 locations

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