Alectinib
Information
- Drug Name
- Alectinib
- Description
- Entry(CIViC)
- 16
CIViC
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In this initial report of a single-arm Phase I and... | ALK | ALK ALK FUSIONS ALK ALK FUSIONS | Sensitivity | true | CIViC Evidence | detail |
| In this case study of a critically ill 29 year old... | ALK | ALK ALK FUSIONS ALK ALK FUSIONS | Sensitivity | true | CIViC Evidence | detail |
| In this Phase I trial (NCT01588028) in 47 patients... | ALK | ALK ALK FUSIONS ALK ALK FUSIONS | Sensitivity | true | CIViC Evidence | detail |
| In this Phase II trial of 87 patients (NCT01871805... | ALK | ALK ALK FUSIONS ALK ALK FUSIONS | Sensitivity | true | CIViC Evidence | detail |
| The I1171T mutation in ALK fusions was found in a ... | ALK | ALK p.Ile1171Thr (p.I1171T) ALK p.Ile1171Thr (p.I1171T) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| The EML4 ALK variant 1 containing NSCLC cell line ... | ALK | ALK EML4-ALK V1180L | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Ba/F3 cells expressing EML4-ALK with 1151 Tins tre... | ALK | ALK EML4-ALK T1151INST | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Ba/F3 cell line expressing EML4-ALK variant 3 with... | ALK | ALK p.Gly1202Arg (p.G1202R) ALK p.Gly1202Arg (p.G1202R) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| EML4-ALK with ALK G1269A mutation was tested for s... | ALK | ALK p.Gly1269Ala (p.G1269A) ALK p.Gly1269Ala (p.G1269A) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| A 51 year old female never-smoker was diagnosed wi... | ALK | ALK p.Ile1171Thr (p.I1171T) ALK p.Ile1171Thr (p.I1171T) | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| CH5424802 treatment resulted in significant tumor ... | ALK | ALK EML4-ALK L1196M | Sensitivity | true | CIViC Evidence | detail |
| Case study describes a female (age 58) never-smoke... | ALK | ALK HIP1-ALK I1171N | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| Case study describes a caucasian male (age 38) nev... | ALK | ALK EML4-ALK I1171S | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| CH5424802 (Alectinib) is effective in inhibiting t... | ALK |
ALK p.Phe1174Leu (p.F1174L) ( ENST00000389048.8, ENST00000618119.4, ENST00000642122.1 ) ALK p.Phe1174Leu (p.F1174L) ( ENST00000618119.4, ENST00000642122.1, ENST00000389048.8 ) |
Sensitivity | true | CIViC Evidence | detail |
| Alectinib is an anaplastic lymphoma kinase tyrosin... | RET | RET UNKNOWN RET FUSION | Sensitivity | true | CIViC Evidence | detail |
| In a randomized, open-label phase 3 trial 303 pati... | ALK | ALK ALK FUSIONS ALK ALK FUSIONS | Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT02075840 | Active, not recruiting | Phase 3 | A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants | August 19, 2014 | September 29, 2026 |
| NCT02314481 | Active, not recruiting | Phase 2 | Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity | May 12, 2017 | May 2026 |
| NCT04591431 | Active, not recruiting | Phase 2 | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy | October 7, 2020 | June 2025 |
| NCT02838420 | Active, not recruiting | Phase 3 | A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) | August 3, 2016 | March 31, 2026 |
| NCT03202940 | Active, not recruiting | Phase 1/Phase 2 | A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC | September 14, 2017 | January 1, 2027 |
| NCT04764188 | Active, not recruiting | An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib | May 10, 2021 | May 10, 2027 | |
| NCT03498521 | Active, not recruiting | Phase 2 | 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 | July 10, 2018 | June 9, 2024 |
| NCT03596866 | Active, not recruiting | Phase 3 | A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer | April 19, 2019 | September 30, 2024 |
| NCT03737994 | Active, not recruiting | Phase 2 | Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer | July 25, 2019 | September 21, 2024 |
| NCT03944772 | Active, not recruiting | Phase 2 | Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) | June 25, 2019 | May 6, 2025 |
| NCT04647110 | Completed | 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. | December 14, 2020 | March 15, 2021 | |
| NCT02621047 | Completed | Phase 1 | Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib | December 4, 2015 | December 8, 2016 |
| NCT03779191 | Completed | Phase 2 | Alectinib in Combination With Bevacizumab in ALK Positive NSCLC | April 8, 2020 | October 30, 2022 |
| NCT01871805 | Completed | Phase 1/Phase 2 | A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) | September 30, 2013 | August 31, 2017 |
| NCT05081674 | Completed | Phase 2 | Brazilian Lung Immunotherapy Study | January 1, 2020 | July 30, 2023 |
| NCT03155009 | Completed | Phase 2 | A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer | July 10, 2017 | September 26, 2019 |
| NCT03158389 | Completed | Phase 1/Phase 2 | NCT Neuro Master Match - N²M² (NOA-20) | May 7, 2018 | February 22, 2023 |
| NCT01984229 | Completed | Phase 1 | A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers | December 2013 | March 2014 |
| NCT02013219 | Completed | Phase 1 | A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC) | April 3, 2014 | February 5, 2020 |
| NCT03546894 | Completed | 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 | July 23, 2018 | February 13, 2023 | |
| NCT02091141 | Completed | Phase 2 | My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors | April 14, 2014 | May 24, 2023 |
| NCT04632992 | Completed | Phase 2 | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response | January 13, 2021 | February 27, 2024 |
| NCT02604342 | Completed | Phase 3 | Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib | November 3, 2015 | August 13, 2018 |
| NCT04351334 | Completed | Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns | March 27, 2020 | November 1, 2022 | |
| NCT03271554 | Completed | Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea | November 9, 2017 | May 28, 2021 | |
| NCT01801111 | Completed | Phase 1/Phase 2 | A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment | June 20, 2013 | October 27, 2017 |
| NCT02023125 | Completed | Phase 1 | A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers. | December 2013 | March 2014 |
| NCT04708639 | Enrolling by invitation | Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients | June 19, 2019 | June 30, 2025 | |
| NCT02271139 | No longer available | Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy | |||
| NCT05987644 | Recruiting | Phase 1/Phase 2 | Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements | March 7, 2024 | January 2027 |
| NCT02925234 | Recruiting | Phase 2 | The Drug Rediscovery Protocol (DRUP Trial) | August 2016 | December 2027 |
| NCT03178552 | Recruiting | Phase 2/Phase 3 | A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) | September 22, 2017 | August 3, 2028 |
| NCT03194893 | Recruiting | Phase 3 | A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer | July 5, 2017 | June 12, 2026 |
| NCT03768063 | Recruiting | Phase 3 | A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study | February 28, 2019 | July 5, 2028 |
| NCT04116541 | Recruiting | Phase 2 | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. | January 28, 2020 | November 2026 |
| NCT04302025 | Recruiting | Phase 2 | A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer | November 6, 2020 | March 6, 2029 |
| NCT04341181 | Recruiting | Phase 2 | ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling | August 24, 2020 | April 30, 2025 |
| NCT04551521 | Recruiting | Phase 2 | CRAFT: The NCT-PMO-1602 Phase II Trial | October 13, 2021 | June 30, 2025 |
| NCT04589845 | Recruiting | Phase 2 | Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study | January 18, 2021 | September 25, 2032 |
| NCT05525858 | Recruiting | KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II | September 28, 2022 | September 2025 | |
| NCT05722886 | Recruiting | Phase 2/Phase 3 | DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol | March 1, 2023 | October 2029 |
| NCT05725200 | Recruiting | Phase 2 | Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer | September 27, 2022 | December 31, 2040 |
| NCT05770037 | Recruiting | Phase 2/Phase 3 | DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Teenage/Young Adults (TYA) and Paediatric Patients With ALK Positive Cancers | December 18, 2023 | October 2029 |
| NCT05834348 | Recruiting | A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. | June 26, 2023 | February 3, 2025 | |
| NCT04774718 | Recruiting | Phase 1/Phase 2 | A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors | September 14, 2021 | July 3, 2030 |
| NCT05015010 | Recruiting | Phase 2 | Alectinib in Neo-adjuvant Treatment of Stage III NSCLC | May 20, 2021 | May 28, 2026 |
| NCT05159245 | Recruiting | Phase 2 | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs | December 10, 2021 | November 25, 2026 |
| NCT05170204 | Recruiting | Phase 3 | A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) | November 1, 2022 | April 14, 2035 |
| NCT05525338 | Recruiting | Phase 4 | Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels | March 23, 2022 | December 31, 2026 |
| NCT04644315 | Terminated | Phase 2 | A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors | May 24, 2021 | May 16, 2022 |
| NCT03445000 | Terminated | Phase 2 | ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer | November 6, 2018 | March 31, 2021 |
| NCT03131206 | Terminated | Phase 1/Phase 2 | A Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer | June 19, 2017 | April 8, 2019 |
| NCT02521051 | Unknown status | Phase 1/Phase 2 | Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer | October 2015 | June 2022 |
| NCT05238831 | Withdrawn | Early Phase 1 | SMMART Adaptive Clinical Treatment (ACT) Trial | January 30, 2023 | May 31, 2026 |
- Trade name (Drug list of Screening Committee of Anticancer Drugs)
- Alecensa
- US Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2015
- Japan Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2014
- Target (Drug list of Screening Committee of Anticancer Drugs)
- ALK
- Disease name (Drug list of Screening Committee of Anticancer Drugs)
- 非小細胞肺がん（ALK fusion gene）