Lung Cancer Clinical Trial
A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
Summary
This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.
Eligibility Criteria
Inclusion Criteria:
Locally advanced or metastatic non-small cell lung cancer (stage IIIB or IV by American Joint Committee on Cancer [AJCC])
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Documented ALK rearrangement based on Food and Drug Administration (FDA)-approved test
Prior treatment with crizotinib and progression according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria. Participants had to have a minimum 1-week wash-out period between the last dose of crizotinib and the first dose of study treatment. Participants can either be chemotherapy-naïve or have received at least one line of platinum-based chemotherapy
Adequate hematologic, hepatic, and renal function
Participants with brain or leptomeningeal metastases are allowed if protocol defined criteria are met
Measurable disease according to RECIST v1.1 prior to administration of first dose of study drug
Exclusion Criteria:
Receipt of any other ALK inhibitors in addition to crizotinib
Receipt of any prior cytotoxic chemotherapy for ALK-positive NSCLC within 4 weeks prior to the first dose of study drug
Participants who received crizotinib or any other tyrosine kinase inhibitors need to have a minimum 1-week washout period before the first dose of study drug
Active or uncontrolled infectious diseases requiring treatment
National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) Grade 3 or higher toxicities due to prior therapy that have not shown improvement and are considered to interfere with current study medication
History of organ transplant
Co-administration of anti-cancer therapies other than those administered in this study
Baseline corrected Q-T interval (QTc) greater than (>) 470 milliseconds, or baseline symptomatic bradycardia (less than 45 heart beats per minute)
Pregnant or breastfeeding women
Known Human Immunodeficiency Virus (HIV) positivity or Acquired Immunodeficiency Syndrome (AIDS)-related illness
History of hypersensitivity to any of the additives in the alectinib formulation
Any clinically significant concomitant disease or condition that could interfere with, or for which treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in the study
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There are 82 Locations for this study
Birmingham Alabama, 35233, United States
Fullerton California, 92835, United States
Orange California, 92868, United States
San Diego California, 92123, United States
San Luis Obispo California, 93401, United States
Santa Monica California, 90404, United States
Miami Florida, 33176, United States
Orlando Florida, 32804, United States
Chicago Illinois, 60612, United States
Zion Illinois, 60099, United States
Saint Louis Missouri, 63110, United States
Henderson Nevada, 89014, United States
New York New York, 10032, United States
Cleveland Ohio, 44106, United States
Dallas Texas, 75246, United States
San Antonio Texas, 78217, United States
Fairfax Virginia, 22031, United States
St. Leonards New South Wales, 2065, Australia
Chermside Queensland, 4032, Australia
Douglas Queensland, 4184, Australia
Edegem , 2650, Belgium
Gent , 9000, Belgium
Roeselare , 8800, Belgium
Herlev , 2730, Denmark
Angers , 49933, France
Brest , 29200, France
Caen , 14076, France
Dijon , 21000, France
Grenoble , 38043, France
Lille , 59020, France
Lyon , 69008, France
Marseille cedex 20 , 13915, France
Pessac , 33600, France
Rennes , 35033, France
St Herblain , 44805, France
Strasbourg , 67091, France
Toulouse , 31059, France
Berlin , 13353, Germany
Düsseldorf , 40489, Germany
Großhansdorf , 22927, Germany
Hemer , 58675, Germany
Koeln , 51109, Germany
Rheine , 48431, Germany
Parma Emilia-Romagna, 43100, Italy
Aviano Friuli-Venezia Giulia, 33081, Italy
Roma Lazio, 00144, Italy
Roma Lazio, 00149, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20141, Italy
Milano Lombardia, , Italy
Firenze Toscana, 50141, Italy
Lido Di Camaiore Toscana, 55043, Italy
Lucca Toscana, 55100, Italy
Perugia Umbria, 06100, Italy
Gyeonggi-do , 10408, Korea, Republic of
Gyeonggi-do , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 6351, Korea, Republic of
Luxembourg , 1210, Luxembourg
Amsterdam , 1066 , Netherlands
Groningen , 9713 , Netherlands
Maastricht , 6229H, Netherlands
Moskva Moskovskaja Oblast, 11547, Russian Federation
Singapore , 11907, Singapore
Singapore , 30843, Singapore
Alicante , 03010, Spain
Barcelona , 08003, Spain
Barcelona , 08028, Spain
Barcelona , 08036, Spain
Madrid , 28014, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Zaragoza , 50009, Spain
Stockholm , 17176, Sweden
Taichung , 407, Taiwan
Tainan , 00704, Taiwan
Taipei , 10002, Taiwan
Aberdeen , AB25 , United Kingdom
London , SW3 6, United Kingdom
London , SW3 6, United Kingdom
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