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Brief Title: A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Official Title: Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC
Study ID: NCT02998528
Brief Summary: The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 0121, Glendale, Arizona, United States
Local Institution - 0081, Los Angeles, California, United States
Local Institution - 0025, Denver, Colorado, United States
Local Institution - 0007, Plainville, Connecticut, United States
Memorial Regional Hospital, Hollywood, Florida, United States
Local Institution - 0136, Miami, Florida, United States
Cancer Institute Of Florida, Orlando, Florida, United States
Orlando Health, Inc., Orlando, Florida, United States
Indian River Medical Center, Vero Beach, Florida, United States
Northwest Georgia Oncology Center, P.C., Marietta, Georgia, United States
Local Institution - 0015, Chicago, Illinois, United States
Local Institution - 0002, Chicago, Illinois, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Local Institution - 0171, Fort Wayne, Indiana, United States
Local Institution - 0170, Lexington, Kentucky, United States
Local Institution - 0186, Louisville, Kentucky, United States
University Medical Center New Orleans, New Orleans, Louisiana, United States
Local Institution - 0151, Baltimore, Maryland, United States
Local Institution - 0001, Baltimore, Maryland, United States
Local Institution - 0006, Boston, Massachusetts, United States
Local Institution - 0008, Boston, Massachusetts, United States
Southcoast Center For Cancer, Fairhaven, Massachusetts, United States
Local Institution - 0012, Detroit, Michigan, United States
Local Institution - 0090, Hattiesburg, Mississippi, United States
St Vincent Frontier Cancer Center, Billings, Montana, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Local Institution - 0009, Hackensack, New Jersey, United States
Valley Hospital Luckow Pavili, Westwood, New Jersey, United States
Local Institution - 0027, Albany, New York, United States
Local Institution - 0011, New York, New York, United States
Local Institution - 0140, High Point, North Carolina, United States
Christ Hospital, Cincinnati, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Genesis Health Care System, Zanesville, Ohio, United States
Kaiser Permanente, Portland, Oregon, United States
Local Institution - 0139, Portland, Oregon, United States
Local Institution - 0010, Philadelphia, Pennsylvania, United States
Local Institution - 0018, Pittsburgh, Pennsylvania, United States
Local Institution - 0013, Charleston, South Carolina, United States
Local Institution - 0021, Charleston, South Carolina, United States
Local Institution - 0146, Greenville, South Carolina, United States
Local Institution - 0092, Nashville, Tennessee, United States
Local Institution - 0005, Nashville, Tennessee, United States
Local Institution - 0035, Austin, Texas, United States
Texas Oncology, Bedford, Texas, United States
Local Institution - 0153, Fort Bliss, Texas, United States
Local Institution - 0106, Houston, Texas, United States
Southwest Cancer Center, Lubbock, Texas, United States
Texas Cancer Center - Sherman, Sherman, Texas, United States
Local Institution - 0143, Tyler, Texas, United States
Local Institution - 0026, Waco, Texas, United States
Intermountain Medical Center, Murray, Utah, United States
Southwest Regional Cancer Clinic, Saint George, Utah, United States
Local Institution - 0003, Salt Lake City, Utah, United States
Local Institution - 0135, Burlington, Vermont, United States
Local Institution - 0125, Fairfax, Virginia, United States
Local Institution - 0198, Fredericksburg, Virginia, United States
Local Institution - 0022, Capital Federal, Buenos Aires, Argentina
Local Institution - 0023, Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Local Institution - 0079, Brasilia, Distrito Federal, Brazil
Local Institution - 0077, Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0076, Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0073, Porto Alegre, RIO Grande DO SUL, Brazil
Fundacao Pio Xii Hosp Cancer De Barretos, Barretos, Sao Paulo, Brazil
Local Institution - 0075, Rio de Janeiro, , Brazil
Local Institution - 0095, Gatineau, Quebec, Canada
Local Institution - 0138, Montreal, Quebec, Canada
Local Institution - 0017, Montreal, Quebec, Canada
Local Institution - 0052, Trois-Rivieres, Quebec, Canada
Local Institution - 0016, Saskatoon, Saskatchewan, Canada
Local Institution - 0161, Beijing, Beijing, China
Local Institution, Beijing, Beijing, China
Local Institution - 0156, Beijing, Beijing, China
Local Institution - 0190, Guangzhou, Guangdong, China
Local Institution - 0192, Changsha, Hunan, China
Local Institution - 0175, Changsha, Hunan, China
Local Institution - 0193, Changsha, Hunan, China
Local Institution - 0166, Nanchang, Jiangxi, China
Local Institution - 0179, Nanchang, Jiangxi, China
Local Institution, Changchun, Jilin, China
Local Institution - 0159, XiAn, Shan1xi, China
Local Institution - 0180, Xian, Shan3xi, China
Local Institution - 0160, Shanghai, Shanghai, China
Local Institution - 0178, Chengdu, Sichuan, China
Local Institution - 0163, Tianjin, Tianjin, China
Local Institution - 0189, Hangzhou, Zhejiang, China
Local Institution - 0183, Hangzhou, Zhejiang, China
Local Institution - 0182, Hangzhou, Zhejiang, China
Local Institution - 0165, Shanghai, , China
Local Institution - 0059, Marseille Cedex 20, , France
Local Institution - 0112, Paris Cedex 5, , France
Local Institution - 0060, Paris, , France
Local Institution - 0064, Pierre Benite, , France
Local Institution - 0061, Rennes Cedex 9, , France
Local Institution - 0113, Strasbourg, , France
Local Institution - 0058, Toulouse, , France
Local Institution - 0062, Tours Cedex 09, , France
Local Institution - 0019, Athens, , Greece
Local Institution - 0122, Thessaloniki, , Greece
Local Institution, Budapest, , Hungary
Local Institution, Szekesfehervar, , Hungary
Local Institution - 0068, Bari, , Italy
Local Institution - 0080, Genova, , Italy
Local Institution - 0070, Perugia, , Italy
Local Institution - 0066, Ravenna, , Italy
Local Institution - 0067, Roma, , Italy
Local Institution - 0131, Nagoya-shi, Aichi, Japan
Local Institution - 0118, Kashiwa-shi, Chiba, Japan
Local Institution - 0111, Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0110, Fukushima-shi, Fukushima, Japan
Local Institution - 0109, Hiroshima-Shi, Hiroshima, Japan
Local Institution - 0147, Sapporo-shi, Hokkaido, Japan
Local Institution - 0133, Kobe-shi, Hyogo, Japan
Local Institution - 0123, Yokohama-shi, Kanagawa, Japan
Local Institution - 0148, Sendai-shi, Miyagi, Japan
Local Institution - 0108, Osaka-sayama-shi, Osaka, Japan
Local Institution - 0127, Osaka-shi, Osaka, Japan
Local Institution - 0119, Sakai-shi, Osaka, Japan
Local Institution - 0132, Sunto-gun, Shizuoka, Japan
Local Institution - 0126, Bunkyo-ku, Tokyo, Japan
Local Institution - 0120, Shinjuku-ku, Tokyo, Japan
Local Institution - 0124, Tokyo, , Japan
Local Institution - 0097, Busan, , Korea, Republic of
Local Institution - 0098, Hwasun, , Korea, Republic of
Local Institution - 0105, Seoul, , Korea, Republic of
Local Institution - 0050, Craiova, , Romania
Local Institution - 0051, Romania, , Romania
Local Institution - 0069, Sector 2, , Romania
Local Institution - 0028, Barcelona, , Spain
Local Institution - 0029, Madrid, , Spain
Local Institution - 0031, Majadahonda - Madrid, , Spain
Local Institution - 0102, New Taipei City, , Taiwan
Local Institution - 0107, Taichung, , Taiwan
Local Institution - 0099, Taipei, , Taiwan
Local Institution - 0100, Taipei, , Taiwan
Local Institution - 0093, Adana, , Turkey
Local Institution - 0084, Ankara, , Turkey
Local Institution - 0115, Istanbul, , Turkey
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR