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This is an open-label, multicenter, single-arm, expanded access study designed to provide alectinib to participants with ALK-rearranged NSCLC after disease progression on or intolerance to prior ALK tyrosine kinase inhibitor (TKI) therapy. Participants will receive alectinib until disease progression, unacceptable toxicity, withdrawal of consent, patient or physician decision to discontinue treatment, death, alectinib becomes commercially available in the United States following approval of alectinib by the FDA, or the Sponsor decides to close the trial, whichever occurs first (approximately 15 months).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alectinib | Drug | Alectinib 600 mg administered orally with food. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Bimingham | Alabama | 35226 | United States | ||
| Southern Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39661917 | Derived | Sikkema BJ, Baart SJ, Paats MS, Smit EF, Schols AMWJ, Mathijssen RHJ, van Rossum EFC, Dingemans AC. Body Weight Gain Associated With Alectinib in Patients With ALK+ Non-Small Cell Lung Cancer: Pooled Analysis of Individual Patient Data From Four Prospective Clinical Trials. J Clin Oncol. 2025 Feb 20;43(6):641-650. doi: 10.1200/JCO-24-01579. Epub 2024 Dec 11. |
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| Daphne |
| Alabama |
| 36526 |
| United States |
| Southern Cancer Center | Mobile | Alabama | 36607 | United States |
| Southern Cancer Center - Mobile | Mobile | Alabama | 36608 | United States |
| Southern Cancer Center, PC | Mobile | Alabama | 36608 | United States |
| Lalita Pandit Inc. | Fountain Valley | California | 92708 | United States |
| University of California San Diego Medical Center; Moores Cancer Center | La Jolla | California | 92037 | United States |
| Loma Linda Cancer Center | Loma Linda | California | 92354 | United States |
| LAC USC Medical Center | Los Angeles | California | 90033 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
| St. Joseph Heritage Healthcare | Sebastopol | California | 95472 | United States |
| Innovative Clinical Research Institute | Whittier | California | 90603 | United States |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
| Loyola University Med Center | Maywood | Illinois | 60153 | United States |
| Investigative Clin Rsch of IN | Indianapolis | Indiana | 46260 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Partners Can Ctr | Boston | Massachusetts | 02115-6084 | United States |
| Beth Israel Deaconess Med Ctr; Hem/Onc | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | United States |
| Henry Ford Health System | West Bloomfield | Michigan | 48322 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Comprehensive Cancer Care, P.C. | St Louis | Missouri | 63141 | United States |
| Billings Clinic Cancer Center; Billings Cancer Research | Billings | Montana | 59101 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| Columbia University Medical Center; Clinical Research Management Office | New York | New York | 10032 | United States |
| W.G. Bill Hefner VA Medical Center | Salisbury | North Carolina | United States |
| Mark H. Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Tulsa Cancer Institute | Tulsa | Oklahoma | 74146 | United States |
| Oregon Health & Science Uni | Portland | Oregon | 97239 | United States |
| Forbes Hospital | Monroeville | Pennsylvania | 15146 | United States |
| Allegheny Valley Hospital | Natrona Heights | Pennsylvania | 15065 | United States |
| Cancer Treatment Centers of America - Eastern Regional Medical Center | Philadelphia | Pennsylvania | 19124 | United States |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | United States |
| West Penn Cancer Institute | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina; Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390-8813 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| University of Washington Seattle Cancer Care Alliance | Seattle | Washington | 98195 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| University of Wisconsin; Oncology | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C582670 | alectinib |
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