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

Brazilian Lung Immunotherapy Study

Phase 2

Completed

Conditions: Lung Neoplasm

Interventions: Drug: Alectinib
Drug: Nivolumab
Drug: Erlotinib
Drug: Pembrolizumab

First Posted Date: 2021-10-18

Last Posted Date: 2023-10-11

Lead Sponsor: Hospital Israelita Albert Einstein

Target Recruit Count: 154

Registration Number: NCT05081674

Locations: 🇧🇷
Hospital Municipal Vila Santa Catarina, São Paulo, Brazil

Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

Phase 2

Active, not recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Alectinib

First Posted Date: 2021-08-20

Last Posted Date: 2024-08-09

Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica

Target Recruit Count: 33

Registration Number: NCT05015010

Locations: 🇮🇹
UOC Oncologia Medica Ospedale Versilia USL Toscana Nord Ovest, Lido Di Camaiore, Lucca, Italy
🇮🇹
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - I.R.S.T., Meldola, Forlì-Cesena, Italy
🇮🇹
Centro di Riferimento Oncologico (CRO) - IRCCS Aviano, Aviano, Pordenone, Italy

and more 17 locations

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

Phase 1

Recruiting

Conditions: ALK Fusion-positive Solid or CNS Tumors

Interventions: Drug: Alectinib

First Posted Date: 2021-03-01

Last Posted Date: 2025-05-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 42

Registration Number: NCT04774718

Locations: 🇺🇸
Lucile Packard Children's Hospital, Palo Alto, California, United States
🇺🇸
Children's Minnesota, Minneapolis, Minnesota, United States
🇧🇷
Hospital de Cancer de Barretos, Barretos, São Paulo, Brazil

and more 30 locations

An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib

Active, not recruiting

Conditions: NSCLC

Interventions: Drug: Alectinib

First Posted Date: 2021-02-21

Last Posted Date: 2025-04-22

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 800

Registration Number: NCT04764188

Locations: 🇦🇷
Clinica Adventista Belgrano, Ciudad Autonoma Buenos Aires, Argentina
🇦🇺
Lifehouse, Camperdown, New South Wales, Australia
🇦🇺
Liverpool Hospital, Liverpool, New South Wales, Australia

and more 113 locations

Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients

Conditions: Mutation
Lung Cancer
ALK Gene Mutation
Resistance, Disease

First Posted Date: 2021-01-14

Last Posted Date: 2021-02-02

Lead Sponsor: Aarhus University Hospital

Target Recruit Count: 40

Registration Number: NCT04708639

Locations: 🇩🇰
Aarhus University Hospital, Aarhus, Denmark

Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

Completed

Conditions: ALK-positive NSCLC

Interventions: Drug: crizotinib
Drug: alectinib
Drug: brigatinib
Drug: ceritinib
Drug: lorlatinib

First Posted Date: 2020-11-30

Last Posted Date: 2023-04-06

Lead Sponsor: Pfizer

Target Recruit Count: 549

Registration Number: NCT04647110

Locations: 🇸🇪
Pfizer Innovations AB, Sollentuna, Sweden

A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

Phase 2

Terminated

Conditions: Melanoma
Pancreatic Neoplasms
Ovarian Neoplasms
Brain Neoplasms
Thyroid Neoplasms
Neuroendocrine Tumors
Salivary Gland Neoplasms
Digestive System Diseases
Neoplasms
Cholangiocarcinoma

Interventions: Drug: Alectinib

First Posted Date: 2020-11-25

Last Posted Date: 2023-08-07

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1

Registration Number: NCT04644315

Locations: 🇺🇸
Science 37-Cannon; Dept 002-Cannon, Culver City, California, United States
🇺🇸
Science 37-Basem; Dept 004- Basem, Culver City, California, United States
🇺🇸
Science 37, Inc, Culver City, California, United States

and more 4 locations

A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

Phase 2

Completed

Conditions: Advanced Unresectable or Metastatic Solid Malignancy

Interventions: Drug: Entrectinib
Drug: Inavolisib
Drug: Alectinib
Drug: Ipatasertib
Drug: Atezolizumab
Drug: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
Drug: Pralsetinib
Drug: Investigator's Choice of Chemotherapy
Drug: Trastuzumab Emtansine
Drug: Tucatinib
Drug: Paclitaxel
Drug: Tiragolumab

First Posted Date: 2020-11-17

Last Posted Date: 2025-01-08

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 252

Registration Number: NCT04632992

Locations: 🇺🇸
Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga, Tennessee, United States
🇺🇸
SCRI Oncology Partners, Nashville, Tennessee, United States
🇺🇸
Alaska Oncology and Hematology, Anchorage, Alaska, United States

and more 35 locations

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Phase 2

Active, not recruiting

Conditions: Other Cancer
Breast Cancer
Gastrointestinal Cancer
Non Small Cell Lung Cancer

First Posted Date: 2020-10-19

Last Posted Date: 2023-10-03

Lead Sponsor: Fondazione per la Medicina Personalizzata

Target Recruit Count: 400

Registration Number: NCT04591431

Locations: 🇮🇹
I.R.S.T. Srl Irccs, Meldola, Italy
🇮🇹
Ospedale Classificato Sacro Cuore - Don Calabria, Negrar, Italy
🇮🇹
I.R.C.C.S. Istituto Oncologico Veneto, Padova, Italy

and more 34 locations

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

Phase 2

Recruiting

Conditions: Solid Tumors

Interventions: Drug: Entrectinib
Drug: Alectinib
Drug: Pralsetinib
Drug: Camonsertib
Drug: Atezolizumab
Drug: Ipatasertib
Drug: Trastuzumab emtansine
Drug: Inavolisib
Drug: Belvarafenib
Drug: Divarasib

First Posted Date: 2020-10-19

Last Posted Date: 2025-05-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 920

Registration Number: NCT04589845

Locations: 🇧🇪
GHdC Site Les Viviers, Charleroi, Belgium
🇧🇪
UZ Antwerpen, Edegem, Belgium
🇨🇳
Jilin Cancer Hospital, Changchun, China

and more 159 locations

Drug Development Updates

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