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NotableSponsor changed: Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair to Medicine Invention Design, IncPrimary endpoints: details revised at 2 of 2 entries · Eligibility criteria expanded, about 29 words · Study description expanded, about 8 words · 1 moreShow 4 more changesShow less
Primary endpoints: details revised at 2 of 2 entries
Eligibility criteria expanded, about 29 words
Study description expanded, about 8 words
Collaborators: 2 to 3
NotableSponsor changed: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair to Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB ChairTrial arms changed: 2 → 1 · Interventions: Alectinib (Drug) to ALECENSA - alectinib hydrochloride capsule (Drug) · Eligibility criteria shortened, about 10 wordsv25Show 3 more changesShow less
Trial arms changed: 2 → 1
Interventions: Alectinib (Drug) to ALECENSA - alectinib hydrochloride capsule (Drug)
NotableLead sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair to Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB ChairInterventions: Alectinib - Study (Drug), Alectinib - Usual (Drug) to Alectinib (Drug) · Study arms: 2 to 1 · Eligibility criteria shortened, about 4 words · 1 morev24Show 4 more changesShow less
Interventions: Alectinib - Study (Drug), Alectinib - Usual (Drug) to Alectinib (Drug)
NotablePrimary endpoint(s) modifiedEligibility criteria expanded, about 2 words · Study description expanded, about 2 wordsv21Show 2 more changesShow less
NotableStart date changed from estimate of Nov 8, 2025 to Mar 18, 2026Trial status: Not Yet Recruiting to Active, Not Recruiting · Study site revised · Study title revisedv14Show 3 more changesShow less
Trial status: Not Yet Recruiting to Active, Not Recruiting
NotablePrimary completion date: Nov 18, 2025 to Nov 18, 2026Start date: Nov 8, 2024 to Nov 8, 2025 · Completion date: Dec 28, 2025 to Dec 28, 2026v13Show 2 more changesShow less
NotablePrimary completion date: Nov 18, 2024 to Nov 18, 2025Start date: Mar 8, 2024 to Nov 8, 2024 · Completion date: Dec 28, 2024 to Dec 28, 2025 · Eligibility criteria shortened, about 10 words · 1 morev11Show 4 more changesShow less
NotablePrimary completion date: May 18, 2024 to Nov 18, 2024Start date: Nov 8, 2023 to Mar 8, 2024 · Completion date: May 28, 2024 to Dec 28, 2024v9Show 2 more changesShow less
Start date: Nov 8, 2023 to Mar 8, 2024
Completion date: May 28, 2024 to Dec 28, 2024
MinorRe-verified, no change to tracked fieldsv8
NotableStart date: Sep 8, 2023 to Nov 8, 2023Trial status: Active, Not Recruiting to Not Yet Recruiting · Study description shortened, about 6 words · Site contact updated · 1 morev7Show 4 more changesShow less
Trial status: Active, Not Recruiting to Not Yet Recruiting
NotablePrimary endpoint revisedInterventions: Alectinib - Study (Drug), Alectinib - Usual (Drug) to Crizotinib - Study (Drug), Crizotinib - Usual (Drug) · Site contact updated · Study title revised · 2 morev2Show 5 more changesShow less
Interventions: Alectinib - Study (Drug), Alectinib - Usual (Drug) to Crizotinib - Study (Drug), Crizotinib - Usual (Drug)
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Explore the relationship between drug target ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Trial Details
NCT Number
NCT05987956
Lead Sponsor
Medicine Invention Design, Inc Collaborators: UnitedHealthcare, Omnicure Clinical Research, Responsible Party: Individual Sponsor: Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair