Lung Cancer Clinical Trial
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
Summary
This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test
Life expectancy of at least 12 weeks
Eastern cooperative oncology group performance status (ECOG PS) of 0-2
Participants with no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
Adequate renal, and hematologic function
Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1) prior to the administration of study treatment
Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline)
Negative pregnancy test for all females of child bearing potential
Use of highly effective contraception as defined by the study protocol
Exclusion Criteria:
Participants with a previous malignancy within the past 3 years
Any gastrointestinal (GI) disorder or liver disease
National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia)
History of organ transplant
Co-administration of anti-cancer therapies other than those administered in this study
Participants with baseline QTc greater than (>) 470 milliseconds or symptomatic bradycardia
Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment
Recipient of any drug with potential QT interval prolonging effects within 14 days prior to the first dose for all participants and while on treatment through the end of the study for crizotinib-treated participants only
History of hypersensitivity to any of the additives in the alectinib and crizotinib drug formulation
Pregnancy or lactation
Any clinically significant disease or condition (or history of) that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in this study
Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participant before trial entry
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There are 116 Locations for this study
Phoenix Arizona, 85259, United States
Northridge California, 91328, United States
Orange California, 92868, United States
Redondo Beach California, 90277, United States
San Francisco California, 94158, United States
Aurora Colorado, 80045, United States
Grand Junction Colorado, 81501, United States
Greeley Colorado, 85234, United States
Deerfield Beach Florida, 33442, United States
Orlando Florida, 32804, United States
Pembroke Pines Florida, 33028, United States
Atlanta Georgia, 30322, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60612, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89128, United States
New York New York, 10032, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Darlinghurst New South Wales, 2010, Australia
St. Leonards New South Wales, 2065, Australia
Waratah New South Wales, 2298, Australia
Woodville South South Australia, 5011, Australia
Victoria , 3168, Australia
Banja Luka , 78000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Porto Alegre RS, 90035, Brazil
Sao Paulo SP, 01246, Brazil
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 1, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Santiago , 84203, Chile
Guangzhou City , 51066, China
Shanghai , 20043, China
San José , 10103, Costa Rica
Cairo , 11555, Egypt
Grenoble , 38043, France
Lille , 59037, France
Lyon , 69373, France
Pessac , 33604, France
Rennes , 35033, France
Karlsruhe , 76137, Germany
Löwenstein , 74245, Germany
Guatemala City , 01015, Guatemala
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Shatin , , Hong Kong
Haifa , 31096, Israel
Kfar-Saba , 44281, Israel
Napoli Campania, 80131, Italy
Parma Emilia-Romagna, 43100, Italy
Ravenna Emilia-Romagna, 48100, Italy
Roma Lazio, 00161, Italy
Milano Lombardia, 20133, Italy
Milano Lombardia, 20141, Italy
Orbassano Piemonte, 10043, Italy
Bari Puglia, 70124, Italy
Catania Sicilia, 95122, Italy
Sant'Andrea Delle Fratte (PG) Umbria, 06132, Italy
Goyang-si , 10408, Korea, Republic of
Seongnam-si , 463-7, Korea, Republic of
Seoul , 003-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Ciudad de México Mexico CITY (federal District), 14080, Mexico
Auckland , , New Zealand
Gda?sk , 80-21, Poland
Lublin , 20-06, Poland
Olsztyn , 10-35, Poland
Otwock , 05-40, Poland
Warszawa , 02-78, Poland
Coimbra , 3000-, Portugal
Lisboa , 1099-, Portugal
Porto , 4200-, Portugal
Obninsk Kaluga, 24903, Russian Federation
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Moscow Moskovskaja Oblast, 10522, Russian Federation
Sankt-peterburg Sankt Petersburg, 19702, Russian Federation
St. Petersburg Sankt Petersburg, 19775, Russian Federation
Novosibirsk , 63004, Russian Federation
Belgrade , 11000, Serbia
Sremska Kamenica , 21204, Serbia
Singapore , 11922, Singapore
Singapore , 16858, Singapore
Badalona Barcelona, 08916, Spain
Sant Andreu de La Barca Barcelona, 08740, Spain
Majadahonda Madrid, 28222, Spain
Alicante , 3010, Spain
Barcelona , 08028, Spain
Sevilla , 41013, Spain
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Lausanne , 1011, Switzerland
Zürich , 8091, Switzerland
Tainan , 00704, Taiwan
Taipei City , 112, Taiwan
Taipei , 10002, Taiwan
Xitun Dist. , 40705, Taiwan
Bangkok , 10400, Thailand
Chiang Rai , 57000, Thailand
Khonkaen , 40000, Thailand
Patumwan , 10330, Thailand
Songkhla , 90110, Thailand
Adana , 01230, Turkey
Ankara , 06100, Turkey
Edirne , 22770, Turkey
Malatya , 44280, Turkey
Dnipropetrovsk , 49102, Ukraine
Kharkiv , 61070, Ukraine
Kyiv , 04107, Ukraine
Lviv , 79031, Ukraine
Birmingham , B9 5S, United Kingdom
London , N7 9N, United Kingdom
London , SE1 9, United Kingdom
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