Lung Cancer - Non Small Cell Squamous Clinical Trial
Official title:
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)
| Verified date | June 2020 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
| Status | Completed |
| Enrollment | 1289 |
| Est. completion date | August 22, 2017 |
| Est. primary completion date | June 9, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com. Inclusion Criteria: - Non small cell lung cancer (NSCLC) - squamous cell - Stage IV or recurrent NSCLC - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: - Brain Metastases - Autoimmune diseases |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution | Cordoba | |
| Argentina | Local Institution | Cordoba | |
| Argentina | Local Institution | Mendoza | |
| Argentina | Local Institution | Quilmes | Buenos Aires |
| Argentina | Local Institution | Rosario | Santa FE |
| Argentina | Local Institution | San Miguel De Tucuman | Tucuman |
| Argentina | Local Institution | Santa Fe | |
| Australia | Local Institution | Bedford Park | South Australia |
| Australia | Local Institution | Box Hill | Victoria |
| Australia | Local Institution | Frankston | Victoria |
| Australia | Local Institution | Heidelberg | Victoria |
| Australia | Local Institution | Wodonga | Victoria |
| Austria | Local Institution | Graz | |
| Austria | Local Institution | Linz | |
| Austria | Local Institution | Salzburg | |
| Belgium | Local Institution | Aalst | |
| Belgium | Local Institution | Liege | |
| Belgium | Local Institution | Sint Niklaas | |
| Belgium | Local Institution | Yvoir | |
| Brazil | Local Institution | Barretos | SAO Paulo |
| Brazil | Local Institution | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution | Curitiba | Parana |
| Brazil | Local Institution | Fortaleza | Ceara |
| Brazil | Local Institution | Passo Fundo | RIO Grande DO SUL |
| Brazil | Local Institution | Porto Alegre | |
| Brazil | Local Institution | Ribeirao Preto | |
| Brazil | Local Institution | Rio de Janeiro | |
| Brazil | Local Institution | Sao Jose dos Campos | SAO Paulo |
| Brazil | Local Institution | Sao Paulo | |
| Brazil | Local Institution | Sao Paulo | |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Oshawa | |
| Chile | Local Institution | Santiago | Metropolitana |
| Chile | Local Institution | Santiago | Metropolitana |
| Chile | Local Institution | Vina Del Mar | Valparaiso |
| China | Local Institution | Beijing | |
| China | Local Institution | Beijing | |
| China | Local Institution | Beijing | |
| China | Local Institution | Beijing | |
| China | Local Institution | Changchun | Jilin |
| China | Local Institution | Guangzhou | Guangdong |
| China | Local Institution | Guanzhou | Guangdong |
| China | Local Institution | Hangzhou | Zhejiang |
| China | Local Institution | Nanjing | Jiangsu |
| China | Local Institution | Nanjing | Jiangsu |
| China | Local Institution | Santiago | |
| China | Local Institution | Shanghai | |
| China | Local Institution | Shanghai | |
| China | Local Institution | Shantou | Guangdong |
| China | Local Institution | Suzhou | Jiangsu |
| China | Local Institution | Urumqi | Xinjiang |
| China | Local Institution | Wuhan | Hubei |
| China | Local Institution | Xi'an | Shaanxi |
| China | Local Institution | Xi'an | Shaanxi |
| Colombia | Local Institution | Monteria | Cordoba |
| Colombia | Local Institution | Pereira | Risaralda |
| Czechia | Local Institution | Ostrava | Poruba |
| Czechia | Local Institution | Prague 2 | |
| Czechia | Local Institution | Praha 5 | |
| Czechia | Local Institution | Praha 8 | |
| Czechia | Local Institution | Pribram V-Zdabor | |
| Czechia | Local Institution | Usti Nad Labem | |
| Czechia | Local Institution | Znojmo | |
| Denmark | Local Institution | Aalborg | |
| Denmark | Local Institution | Herlev | |
| Denmark | Local Institution | Hillerod | |
| Denmark | Local Institution | Naestved | |
| Denmark | Local Institution | Odense | |
| France | Local Institution | Caen Cedex 05 | |
| France | Local Institution | Marseille Cedex 20 | |
| France | Local Institution | Paris | |
| France | Local Institution | Poitiers | |
| France | Local Institution | Rennes Cedex 9 | |
| France | Local Institution | Toulouse Cedex 9 | |
| France | Local Institution | Vandoeuvre-les-nancy | |
| Germany | Local Institution | Bad Berka | |
| Germany | Local Institution | Bochum | |
| Germany | Local Institution | Darmstadt | |
| Germany | Local Institution | Dresden | |
| Germany | Local Institution | Frankfurt Am Main | |
| Germany | Local Institution | Gauting | |
| Germany | Local Institution | Grosshandsdorf | |
| Germany | Local Institution | Hamburg | |
| Germany | Local Institution | Heidelberg | |
| Germany | Local Institution | Kassel | |
| Germany | Local Institution | Lubeck | |
| Germany | Local Institution | Mainz | |
| Germany | Local Institution | Muenchen | |
| Germany | Local Institution | Neumunster | |
| Germany | Local Institution | Nuernberg | |
| Germany | Local Institution | Regensburg | |
| Germany | Local Institution | Tuebingen | |
| Germany | Local Institution | Ulm | |
| Germany | Local Institution | Villingen-Schwenningen | |
| Hong Kong | Local Institution | Hong Kong | |
| Hong Kong | Local Institution | Hong Kong | |
| Hong Kong | Local Institution | New Territories | |
| Hungary | Local Institution | Budapest | |
| Hungary | Local Institution | Budapest | |
| Hungary | Local Institution | Deszk | |
| Hungary | Local Institution | Farkasgyepu | |
| Hungary | Local Institution | Gyula | |
| Hungary | Local Institution | Matrahaza | |
| Hungary | Local Institution | Nyiregyhaza | |
| Hungary | Local Institution | Pecs | |
| Hungary | Local Institution | Sopron | |
| Hungary | Local Institution | Szekesfehervar | |
| Hungary | Local Institution | Szolnok | |
| Ireland | Local Institution | Dublin | |
| Ireland | Local Institution | Dublin | |
| Ireland | Local Institution | Dublin | |
| Ireland | Local Institution | Galway | |
| Israel | Local Institution | Beer Sheva | |
| Israel | Local Institution | Haifa | |
| Israel | Local Institution | Jerusalem | |
| Israel | Local Institution | Nahariya | |
| Israel | Local Institution | Petah-Tikva | |
| Israel | Local Institution | Rehovot | |
| Israel | Local Institution | Tel Aviv | |
| Israel | Local Institution | Tel-aviv | |
| Israel | Local Institution | Tel-hashomer | |
| Israel | Local Institution | Zerifin | |
| Italy | Local Institution | Benevento | |
| Italy | Local Institution | Bologna | |
| Italy | Local Institution | Lido Di Camaiore | |
| Italy | Local Institution | Lucca | |
| Italy | Local Institution | Monza | |
| Italy | Local Institution | Padova | |
| Italy | Local Institution | Perugia | |
| Italy | Local Institution | Siena | |
| Italy | Local Institution | Sondrio | |
| Italy | Local Institution | Terni | |
| Italy | Local Institution | Treviglio | |
| Japan | Local Institution | Akashi, Hyogo | |
| Japan | Local Institution | Chuo-ku | Tokyo |
| Japan | Local Institution | Fukuoka | |
| Japan | Local Institution | Hirakata-shi | Osaka |
| Japan | Local Institution | Kanazawa-shi | Ishikawa |
| Japan | Local Institution | Kashiwa | Chiba |
| Japan | Local Institution | Kurashiki-shi | Okayama |
| Japan | Local Institution | Kurashiki-shi | Okayama |
| Japan | Local Institution | Matsuyama, Ehime | |
| Japan | Local Institution | Nagoya | Aichi |
| Japan | Local Institution | Nagoya-shi | Aichi |
| Japan | Local Institution | Natori-shi | Miyagi |
| Japan | Local Institution | Osaka-shi | Osaka |
| Japan | Local Institution | Osakasayama-city | |
| Japan | Local Institution | Sapporo Hokkaido | |
| Japan | Local Institution | Sapporo, Hokkaido | |
| Japan | Local Institution | Sendai | Miyagi |
| Japan | Local Institution | Sendai, Miyagi | |
| Japan | Local Institution | Sunto-gun | Shizuoka |
| Japan | Local Institution | Takatsuki | |
| Japan | Local Institution | Tokyo | |
| Japan | Local Institution | Ube-shi | Yamaguchi |
| Japan | Local Institution | Yokohama-Shi | Kanagawa |
| Japan | Local Institution | Yokohama-shi | Kanagawa |
| Korea, Republic of | Local Institution | Busan | |
| Korea, Republic of | Local Institution | Cheonju-si | Chungcheongbuk-do |
| Korea, Republic of | Local Institution | Daegu | |
| Korea, Republic of | Local Institution | Goyang-si | Gyeonggi-do |
| Korea, Republic of | Local Institution | Gyeonggi-do | |
| Korea, Republic of | Local Institution | Seoul | |
| Korea, Republic of | Local Institution | Seoul | |
| Korea, Republic of | Local Institution | Seoul | |
| Korea, Republic of | Local Institution | Seoul | |
| Korea, Republic of | Local Institution | Seoul | |
| Korea, Republic of | Local Institution | Seoul | |
| Korea, Republic of | Local Institution | Seoul | |
| Korea, Republic of | Local Institution | Seoul | Kangnam-gu |
| Korea, Republic of | Local Institution | Seoul | Seodaemungu |
| Korea, Republic of | Local Institution | Suwon | |
| Korea, Republic of | Local Institution | Suwon-si | Gyeonggi-do |
| Mexico | Local Institution | Mexico | Distrito Federal |
| Mexico | Local Institution | Monterrey | Nuevo LEON |
| Mexico | Local Institution | Zapopan | Jalisco |
| Netherlands | Local Institution | Breda | |
| Netherlands | Local Institution | Harderwijk | |
| Netherlands | Local Institution | Hertogenbosch | |
| Netherlands | Local Institution | Nieuwegein | |
| Peru | Local Institution | Arequipa | |
| Peru | Local Institution | Cercado | |
| Peru | Local Institution | Lima | |
| Peru | Local Institution | Trujillo | LA Libertad |
| Poland | Local Institution | Elblag | |
| Poland | Local Institution | Gdansk | |
| Poland | Local Institution | Gdansk- Zaspa | |
| Poland | Local Institution | Grudziadz | |
| Poland | Local Institution | Olsztyn | |
| Poland | Local Institution | Otwock | |
| Poland | Local Institution | Poznan | |
| Poland | Local Institution | Szczecin | |
| Poland | Local Institution | Torun | |
| Poland | Local Institution | Warsaw | |
| Portugal | Local Institution | Lisboa | |
| Portugal | Local Institution | Lisboa | |
| Portugal | Local Institution | Porto | |
| Portugal | Local Institution | Santa Maria Da Feira | |
| Portugal | Local Institution | Sao Martinho Do Bispo | Coimbra |
| Portugal | Local Institution | Vila Nova De Gaia | |
| Romania | Local Institution | Bucharest | |
| Romania | Local Institution | Bucuresti | |
| Romania | Local Institution | Cluj Napoca | |
| Romania | Local Institution | Sibiu | |
| Romania | Local Institution | Suceava | |
| Romania | Local Institution | Timisoara | |
| Russian Federation | Local Institution | Chelyabinsk | |
| Russian Federation | Local Institution | Kazan | |
| Russian Federation | Local Institution | Moscow | |
| Russian Federation | Local Institution | Moscow | |
| Russian Federation | Local Institution | Pyatigorsk | |
| Russian Federation | Local Institution | Saint Petersburg | |
| Russian Federation | Local Institution | St-Peterburg | |
| Russian Federation | Local Institution | St. Petersburg | |
| Russian Federation | Local Institution | Tula | |
| Singapore | Local Institution | Singapore | |
| South Africa | Local Institution | Cape Town | |
| South Africa | Local Institution | Durban | |
| South Africa | Local Institution | Panorama,cape Town | Western CAPE |
| South Africa | Local Institution | Vereeniging | Gauteng |
| Spain | Local Institution | Avila | |
| Spain | Local Institution | Barakaldo | Vizcaya |
| Spain | Local Institution | Benidorm-alicante | |
| Spain | Local Institution | Castellon | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Manresa | |
| Spain | Local Institution | Ourense | |
| Spain | Local Institution | Valencia | |
| Spain | Local Institution | Valencia | |
| Sweden | Local Institution | Gothenburg | |
| Sweden | Local Institution | Lund | |
| Sweden | Local Institution | Stockholm | |
| Sweden | Local Institution | Umea | |
| Switzerland | Local Institution | Basel | |
| Switzerland | Local Institution | Winterthur | |
| Taiwan | Local Institution | Changhua City | |
| Taiwan | Local Institution | Chiayi | |
| Taiwan | Local Institution | Kaohsiung County | |
| Taiwan | Local Institution | Taichung | |
| Taiwan | Local Institution | Taichung | |
| Taiwan | Local Institution | Taipei | |
| Taiwan | Local Institution | Taipei | |
| Taiwan | Local Institution | Taipei City | |
| Thailand | Local Institution | Bangkok | Tungpayathai |
| Thailand | Local Institution | Bangkok | |
| Thailand | Local Institution | Bangkok | |
| Thailand | Local Institution | Bangkok | |
| Thailand | Local Institution | Chiang Mai | |
| Thailand | Local Institution | Songkhla | |
| United Kingdom | Local Institution | Dundee | Angus/forfarshire |
| United Kingdom | Local Institution | Nottingham | |
| United Kingdom | Local Institution | Sheffield | |
| United Kingdom | Local Institution | Southampton | Hampshire |
| United Kingdom | Local Institution | Truro | Cornwall |
| United States | Texas Oncology, PA - South Austin Cancer Center | Austin | Texas |
| United States | Blue Ridge Cancer Care | Blacksburg | Virginia |
| United States | Lynn Cancer Institute Center For Hematology-Oncology | Boca Raton | Florida |
| United States | Gabrail Cancer Center Research | Canton | Ohio |
| United States | Associated in Oncology and Hematology | Chattanooga | Tennessee |
| United States | University Of Illinois At Chicago Medical Center | Chicago | Illinois |
| United States | Wjb Dorn Va Medical Center | Columbia | South Carolina |
| United States | Durham Va Medical Center (111g) | Durham | North Carolina |
| United States | Cancer Center Of The Carolinas | Greenville | South Carolina |
| United States | Kentucky Cancer Clinic | Hazard | Kentucky |
| United States | Carolina Biooncology Institute | Huntersville | North Carolina |
| United States | St. Francis Hospital & Health Centers | Indianapolis | Indiana |
| United States | Integrated Community Oncology Network | Jacksonville | Florida |
| United States | University Of Kansas Cancer Center | Kansas City | Missouri |
| United States | Tennessee Cancer Specialists | Knoxville | Tennessee |
| United States | Thompson Oncology Group | Knoxville | Tennessee |
| United States | Clinical Research Alliance, Inc. | Lake Success | New York |
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | Novant Health Oncology Specialists | Lexington | North Carolina |
| United States | Norton Cancer Institute | Louisville | Kentucky |
| United States | Wisconsin Institutes for Medical Research | Madison | Wisconsin |
| United States | Montgomery Cancer Center | Mount Sterling | Kentucky |
| United States | Floyd Memorial Cancer Center Of Indiana | New Albany | Indiana |
| United States | Kaiser Permanente Northwest Region | Portland | Oregon |
| United States | Quincy Medical Group | Quincy | Illinois |
| United States | Washington University School Of Medicine | Saint Louis | Missouri |
| United States | Sharp Memorial Hospital | San Diego | California |
| United States | Guthrie Medical Group, P.C. | Sayre | Pennsylvania |
| United States | Presence Medical Group Hematology Oncology | Skokie | Illinois |
| United States | Southern Illinois University School Of Medicine | Springfield | Illinois |
| United States | Oklahoma Oncology And Hematology, Pc Dba | Tulsa | Oklahoma |
| United States | Va Connecticut Healthcare System | West Haven | Connecticut |
| United States | St Joseph Mercy Hospital | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint | Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants. | Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start) | |
| Secondary | Overall Survival (OS) in All Randomized Participants at Primary Endpoint | Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants. | Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start) | |
| Secondary | Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint | Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization. | Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start) |