Farmakogenomik IND SNP Klinik Çalışması - Alectinib ve Tek Nükleotid Polimorfizmleri

Sade dilde özet

Bu çalışma, ALK pozitif metastatik küçük hücreli dışı akciğer kanseri (non-small cell lung cancer) olan hastalarda Alectinib tedavisi ile tek nükleotid polimorfizmleri (SNP; kişiye özgü genetik farklılıklar) arasındaki ilişkiyi incelemektedir. Çalışmaya, en az 90 gündür günde iki kez Alectinib kullanan, 24-64 yaş arası hastalar alınmaktadır. Çalışma Faz 2/Faz 3 aşamasında yürütülmekte olup şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

PHASE2/PHASE3

Durum

Devam ediyor, katılım kapalı

Sponsor

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Müdahale

Alectinib - Usual, Alectinib - Study

Başlangıç

18.03.2026

Tahmini bitiş

28.12.2026

Ülkeler

United States

İlgili genler

Merkezler

• Doral, United States
• Rockville, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

* Select 600 patients with Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:

  * Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
  * Had no further NSCLC metastatic or growth in more than previous 90 days
* 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 600 mg orally twice daily, film coated diagnosed metastatic ALK-positive NSCLC, like as the usual approach group.
* The study approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...86 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, film coated diagnosed metastatic ALK-positive NSCLC, like as the study approach group.

Inclusion Criteria:

* 1\. Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
* Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
* Had no further NSCLC metastatic or growth in more than previous 90 days
* 2\. Suitable for enough blood-drawing
* 3\. Random and double blind
* 4\. Measurable disease
* 5\. Adequate organ functions
* 6\. Adequate performance status
* 7\. Age 24-64 years old
* 8\. Sign an informed consent form
* 9\. Receive blood-drawing

Exclusion Criteria:

* 1\. Pneumonectomy
* 2\. Treatment with other anti-cancer therapies and cannot be stopped currently
* 3\. Pregnancy
* 4\. Breast-feeding
* 5\. The patients with other serious intercurrent illness or infectious diseases
* 6\. Have more than one different kind of cancer at the same time
* 7\. Serious Allergy to Drugs
* 8\. Serious Bleed Tendency
* 9\. Serious Risks or Serious Adverse Events of the drug product
* 10\. The prohibition of drug products
* 11\. Have no therapeutic effects
* 12\. Follow up to the most current label