Alectinib
- Generic Name
- Alectinib
- Brand Names
- Alecensa, Alecensaro
- Drug Type
- Small Molecule
- Chemical Formula
- C30H34N4O2
- 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
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
- First Posted Date
- 2025-03-06
- Last Posted Date
- 2025-05-08
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 800
- Registration Number
- NCT06862869
- Locations
- 🇨🇳
Shanghai Pulmonary Hospital, Shanghai, China
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
- Conditions
- Non-small Cell Lung CancerAnaplastic Lymphoma Kinase-positive
- Interventions
- Drug: Neladalkib (NVL-655)
- First Posted Date
- 2025-01-09
- Last Posted Date
- 2025-03-12
- Lead Sponsor
- Nuvalent Inc.
- Target Recruit Count
- 450
- Registration Number
- NCT06765109
- Locations
- 🇺🇸
Washington University Center for Advanced Medicine, Saint Louis, Missouri, United States
🇺🇸Clinical Research Alliance Inc., New Hyde Park, New York, United States
Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2024-11-29
- Last Posted Date
- 2024-11-29
- Lead Sponsor
- Guangdong Association of Clinical Trials
- Target Recruit Count
- 342
- Registration Number
- NCT06709274
- Locations
- 🇨🇳
Dongguan People's Hospital, Dongguan, Guangdong, China
🇨🇳The First People's Hospital of Foshan, Foshan, Guangdong, China
🇨🇳Guangdong Provincial People's Hostpital, Guangzhou, Guangdong, China
Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS
- Conditions
- Rare Tumour
- Interventions
- Drug: Other
- First Posted Date
- 2024-11-18
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Peking University Shenzhen Hospital
- Target Recruit Count
- 200
- Registration Number
- NCT06692491
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2024-10-02
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 150
- Registration Number
- NCT06624059
- Locations
- 🇦🇺
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
🇦🇺Calvary Mater Newcastle, Waratah, New South Wales, Australia
🇨🇳Xiangya Hospital of Centre-South University, Changsha, China
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
- Conditions
- Hypogonadism, MaleNSCLC Stage IVSex DisorderErectile Dysfunction
- Interventions
- First Posted Date
- 2024-08-01
- Last Posted Date
- 2024-08-09
- Target Recruit Count
- 80
- Registration Number
- NCT06532149
- Locations
- 🇮🇹
Fondazione Policlinico Gemelli IRCCS, Rome, Italy
Alectinib in Combination with Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided with Serum RNase1 and Tumor Expression of PD-L1
- Conditions
- Hepatocellular Carcinoma
- Interventions
- First Posted Date
- 2024-04-09
- Last Posted Date
- 2025-02-12
- Lead Sponsor
- China Medical University Hospital
- Target Recruit Count
- 8
- Registration Number
- NCT06354387
- Locations
- 🇨🇳
CMUH, Taichung, Taiwan
Alectinib-induced Endocrine Toxicity
- First Posted Date
- 2024-04-01
- Last Posted Date
- 2024-04-01
- Target Recruit Count
- 98
- Registration Number
- NCT06339554
- Locations
- 🇮🇹
Fondazione Policlinico Gemelli IRCCS, Rome, Italy
Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements
- Conditions
- Lung CancerNSCLCBrain Metastases
- Interventions
- Radiation: Stereotactic Radiosurgery
- First Posted Date
- 2023-08-14
- Last Posted Date
- 2025-05-04
- Lead Sponsor
- Joshua Palmer
- Target Recruit Count
- 56
- Registration Number
- NCT05987644
- Locations
- 🇺🇸
Stanford University, Stanford, California, United States
🇺🇸Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- First Posted Date
- 2023-08-14
- Last Posted Date
- 2024-08-13
- Lead Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- Target Recruit Count
- 600
- Registration Number
- NCT05987956
- Locations
- 🇺🇸
Medicine Invention Design, Inc. - IORG0007849, Rockville, Maryland, United States
Drug Development Updates
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