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Alectinib

Phase 2

Cancer | Small molecule | Oncology |GSK plc|Last Updated: Jul 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04341181ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic ProfilingPHASE2 RECRUITING 300Aug 24, 2020Apr 30, 2030Jul 25, 20257 Denmark
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Study Endpoints
Primary Endpoints
Response rate
16 weeks

Response according to RECIST

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AlectinibEXPERIMENTALAlectinib for patients with a molecular tumor profile that can potentially be targeted by Alectinib.
AtezolizumabEXPERIMENTALAtezolizumab for patients with a molecular tumor profile that can potentially be targeted by Atezolizumab.
AvelumabEXPERIMENTALAvelumab for patients with a molecular tumor profile that can potentially be targeted by Avelumab.
AxitinibEXPERIMENTALAxitinib for patients with a molecular tumor profile that can potentially be targeted by Axitinib.
ErlotinibEXPERIMENTALErlotinib for patients with a molecular tumor profile that can potentially be targeted by Erlotinib.
Vemurafenib plus Cobimetinib (combination)EXPERIMENTALVemurafenib plus Cobimetinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Vemurafenib plus Cobimetinib.
Trastuzumab plus Pertuzumab (combination)EXPERIMENTALTrastuzumab plus Pertuzumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Trastuzumab plus Pertuzumab.
Trastuzumab emtansinEXPERIMENTALTrastuzumab emtansin for patients with a molecular tumor profile that can potentially be targeted by Trastuzumab emtansin.
VismodegibEXPERIMENTALVismodegib for patients with a molecular tumor profile that can potentially be targeted by Vismodegib.
NiraparibEXPERIMENTALNiraparib for patients with a molecular tumor profile that can potentially be targeted by Niraparib.
Interventions
NameTypeDescription
AlectinibDRUGAlectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Alectinib might be expected based on their molecular tumor profile.
AtezolizumabDRUGAtezolizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Atezolizumab might be expected based on their molecular tumor profile.
AvelumabDRUGAvelumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Avelumab might be expected based on their molecular tumor profile.
AxitinibDRUGAxitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Axitinib might be expected based on their molecular tumor profile.
ErlotinibDRUGErlotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Erlotinib might be expected based on their molecular tumor profile.
Vemurafenib plus Cobimetinib (combination)DRUGVemurafenib plus Cobimetinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vemurafenib plus Cobimetinib might be expected based on their molecular tumor profile.
Trastuzumab plus Pertuzumab (combination)DRUGTrastuzumab plus Pertuzumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Trastuzumab plus Pertuzumab might be expected based on their molecular tumor profile.
Trastuzumab emtansineDRUGTrastuzumab emtansine treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Trastuzumab emtansine might be expected based on their molecular tumor profile.
VismodegibDRUGVismodegib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vismodegib might be expected based on their molecular tumor profile.
NiraparibDRUGNiraparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Niraparib might be expected based on their molecular tumor profile.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Patient (age≥ 18 years) with a histologically-proven locally advanced or metastatic malignant disease who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated. 2. ECOG perform...

Countries:Denmark
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04341181studyFirstPostDate: changed