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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

Target class-Tinib (Kinase)
ModalitySmall molecule

Also known as Alectinib - Usual

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 391 trials

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 and has not been approved by the FDA. The drug is being evaluated in a controlled, randomized, double-blind clinical trial.

What does Alectinib - Usual target?

Alectinib - Usual belongs to the -tinib class of kinase inhibitors, meaning it targets kinases, enzymes that regulate cellular signaling. By inhibiting these kinases, the drug aims to interfere with cancer cell growth and survival in Non-small Cell Lung Cancer.

Who is developing Alectinib - Usual?

Alectinib - Usual is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker DSGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Non-small Cell Lung Cancer.

What phase is Alectinib - Usual in?

Alectinib - Usual is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received FDA approval. The ongoing Phase 2 trial is active but not recruiting participants, with an enrollment target of 600 patients.

What clinical trials is Alectinib - Usual in?

Alectinib - Usual is being studied in one active Phase 2 clinical trial with the identifier NCT05987956. The trial is titled 'Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms' and is being conducted in the United States with 600 participants.

Is Alectinib - Usual the same as Alectinib?

Yes, Alectinib - Usual is also known as Alectinib. The drug is being developed under the name Alectinib - Usual, but it is the same compound. This alternative name is used in clinical trial registrations and research documentation.