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Alectinib - Usual

Phase 2

Non-small Cell Lung Cancer | Small molecule | Oncology |Design Therapeutics, Inc.|Last Updated: Apr 30, 2026

Target and mechanism

Molecular targetALK, EML4, RET
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Alectinib - Usual · 1 trial · 1 indication

Phase 2 1
NCT05987956Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide PolymorphismsNon-small Cell Lung Cancer
ACTIVE NOT_RECRUITING600 Analytics
PHASE2ACTIVE NOT_RECRUITING
Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Up to 12 weeks

* Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...01 on ALECENSA - alectinib 600 mg orally twice daily, after biopsy diagnosis, to be the usual approach group. * Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...86 on ALECENSA - alectinib 600 mg orally twice daily, after biopsy diagnosis, to be the study approach group. * Measure above every NSCLC patient-specific Alectinib drug target (ALK) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence. * Measure above every NSCLC patient-specific Alectinib drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every NSCLC patient-specific CYP4503A4 SNP genotype in whole genome DNA sequence.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH

Treatment Arms

ArmTypeDescription
Alectinib - UsualEXPERIMENTAL* Usual ALECENSA - Alectinib * Chemotherapy (NDC...01) * Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily * Usual Approach Group (NDC...01) * ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
Alectinib - StudyEXPERIMENTAL* Study ALECENSA - Alectinib * Chemotherapy (NDC...86) * Study ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily * Study Approach Group (NDC...86) * ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Interventions

NameTypeDescription
Alectinib - UsualDRUGUsual Alectinib Chemotherapy (NDC...01) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
Alectinib - StudyDRUGStudy Alectinib Chemotherapy (NDC...86) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
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Eligibility Criteria

Age Range22 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

* Select 600 Non-Small Cell Lung Cancer Patients who are suitable for blood-drawing. * Dosage Duration at least 90 days * The usual approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA - alectinib hydrochloride capsule 6...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 393 trials

Recent Changes (Last 90 Days)

LOWMay 24, 2026NCT05987956studyFirstPostDate: changed

Frequently asked questions about Alectinib - Usual

What is Alectinib - Usual used for in Non-small Cell Lung Cancer?

Alectinib - Usual is an investigational small molecule being studied for the treatment of Non-small Cell Lung Cancer. It is currently in Phase 2 clinical development. The drug is being evaluated in a randomized, double-blind, controlled trial that uses a biomarker to select patients.

What does Alectinib - Usual target?

Alectinib - Usual targets ALK, EML4, and RET, and it is an inhibitor of these molecular targets. By inhibiting these targets, the drug is designed to interfere with cancer cell growth and survival in Non-small Cell Lung Cancer.

Who makes Alectinib - Usual?

Alectinib - Usual is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol DSGN. The company is conducting clinical research on this drug for Non-small Cell Lung Cancer.

What phase is Alectinib - Usual in?

Alectinib - Usual is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and efficacy for Non-small Cell Lung Cancer.

What clinical trials is Alectinib - Usual in?

Alectinib - Usual is being studied in one active clinical trial with the identifier NCT05987956. This Phase 2 trial, titled 'Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms,' is enrolling 600 participants with Non-small Cell Lung Cancer in the United States.

Is Alectinib - Usual the same as alectinib?

Alectinib - Usual is a specific formulation or version of alectinib, a drug that targets ALK, EML4, and RET. It is being developed by Design Therapeutics, Inc. under the name Alectinib - Usual for Non-small Cell Lung Cancer.