Spots Global Cancer Trial Database for Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer
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Trial Identification
Brief Title: Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer
Official Title: A Phase 2, Open-Label, Multi-Center Study to Assess Safety and Efficacy of Second/Third-Line Treatment With NAB®-Paclitaxel (ABI-007) In Combination With Epigenetic Modifying Therapy Of CC-486, Or Immunotherapy of Durvalumab (MEDI4736), Or As Monotherapy In Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC): Abound.2L+
Study ID: NCT02250326
Conditions
Study Description
Brief Summary: This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying therapy of CC-486 or immunotherapy of durvalumab, and nab-paclitaxel monotherapy in subjects with advanced non-small cell lung cancer (NSCLC).
Detailed Description: This Phase 2 study will test the hypothesis that epigenetic modifying therapy of CC-486 or immunotherapy of durvalumab can improve the anti-tumor activity of nab-paclitaxel in subjects with advanced non-small cell lung cancer (NSCLC) who have received no more than one prior chemotherapy regimen for their advanced disease. It will further assess efficacy and safety of nab-paclitaxel monotherapy in this setting. Each subject will receive study therapy as second- or third-line of treatment. Approximately 240 male and female subjects with advanced NSCLC will be assigned to one of the following treatment arms (approximately 80 subjects per group): nab-paclitaxel /CC-486 combination therapy, nab-paclitaxel/durvalumab combination therapy or nab-paclitaxel monotherapy prior to receiving first dose of Investigational Product. A permuted-block randomization method will be employed to assign the subjects among the treatment arms that are enrolling simultaneously, when applicable, stratified by the following baseline factors: ECOG performance status (0 versus 1), gender (males versus females), and smoker (yes versus no). Treatment assignments of subjects to the nab-paclitaxel/CC-486 combination therapy and nab-paclitaxel monotherapy arms will be conducted completely in a randomized fashion.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF Helen Diller Medical Center at Parnassus Heights, San Francisco, California, United States
Hospital of Central Connecticut Gynecologic Oncology, New Britain, Connecticut, United States
University Cancer and Blood Center, LLC, Athens, Georgia, United States
Local Institution - 603, Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Weill Cornell Medical College - New York - Presbyterian Hospital, New York, New York, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
Associates in Oncology and Hematology, Chattanooga, Tennessee, United States
Millennium Oncology, Houston, Texas, United States
Local Institution - 642, Ottawa, Ontario, Canada
Local Institution - 641, Montreal, Quebec, Canada
Local Institution - 653, Lille, , France
Local Institution - 651, Saint Herblain, , France
Local Institution - 652, Villejuif, , France
Local Institution - 664, Essen, , Germany
Local Institution - 663, Grosshansdorf, , Germany
Local Institution - 661, Loewenstein, , Germany
Local Institution - 673, Bologna, , Italy
Local Institution - 674, Parma, , Italy
Local Institution - 672, Udine, , Italy
Local Institution - 693, Barcelona, , Spain
Local Institution - 695, Barcelona, , Spain
Local Institution - 692, Madrid, , Spain
Local Institution - 691, Madrid, , Spain
Local Institution - 694, Malaga, , Spain
Local Institution - 697, Valencia, , Spain
Local Institution - 696, Valencia, , Spain
Local Institution - 630, London, Greater London, United Kingdom
Local Institution - 634, Bebington, Wirral, , United Kingdom
Local Institution - 633, Birmingham, , United Kingdom
Local Institution - 635, London, , United Kingdom
Local Institution - 636, Manchester, , United Kingdom
Local Institution - 632, Newcastle Upon Tyne, , United Kingdom
Local Institution - 631, Oxford, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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