Stage IV or Recurrent Non-Small Cell Lung Cancer Clinical Trial
Official title:
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer
| Verified date | February 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy
| Status | Completed |
| Enrollment | 541 |
| Est. completion date | May 27, 2022 |
| Est. primary completion date | July 1, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 1 - Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria - PD-L1+ on immunohistochemistry testing performed by central lab - Men and women, ages = 18 years of age Exclusion Criteria: - Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy - Known anaplastic lymphoma kinase (ALK) translocations - Untreated central nervous system (CNS) metastases - Previous malignancies - Active, known or suspected autoimmune disease |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0051 | Berazategui | Buenos Aires |
| Argentina | Local Institution - 0049 | Capital Federal | Buenos Aires |
| Argentina | Local Institution - 0052 | Ciudad Autonoma De Buenos Aire | Buenos Aires |
| Argentina | Local Institution - 0048 | Cordoba | |
| Argentina | Local Institution - 0050 | Cordoba | |
| Australia | Local Institution - 0091 | Brisbane | Queensland |
| Australia | Local Institution - 0090 | Camperdown | New South Wales |
| Australia | Local Institution - 0071 | Elizabeth Vale | South Australia |
| Australia | Local Institution - 0072 | Fitzroy | Victoria |
| Australia | Local Institution - 0104 | Heidelberg | Victoria |
| Austria | Local Institution - 0088 | Wels | |
| Austria | Local Institution - 0087 | Wien | |
| Belgium | Local Institution - 0044 | Brussels | |
| Belgium | Local Institution - 0055 | Edegem | |
| Belgium | Local Institution - 0056 | Gent | |
| Belgium | Local Institution - 0062 | Leuven | |
| Brazil | Local Institution - 0135 | Barretos | Sao Paulo |
| Brazil | Local Institution - 0134 | Ijui | Rio Grande Do Sul |
| Brazil | Local Institution - 0133 | Porto Alegre | Rio Grande Do Sul |
| Canada | Local Institution - 0086 | Calgary | Alberta |
| Canada | Local Institution - 0115 | Hamilton | Ontario |
| Canada | Local Institution - 0110 | Montreal | Quebec |
| Canada | Local Institution - 0109 | Rimouski | Quebec |
| Canada | Local Institution - 0113 | Toronto | Ontario |
| Czechia | Local Institution - 0059 | Olomouc | |
| Czechia | Local Institution - 0061 | Ostrava - Poruba | |
| Czechia | Local Institution - 0058 | Praha 8 | |
| Czechia | Local Institution - 0060 | Usti nad Labem | |
| Finland | Local Institution - 0120 | Helsinki | |
| Finland | Local Institution - 0119 | Tampere | |
| Finland | Local Institution - 0118 | Vaasa | |
| France | Local Institution - 0123 | Caen | |
| France | Local Institution - 0105 | Lille | |
| France | Local Institution - 0102 | Marseille Cedex 20 | |
| France | Local Institution - 0167 | Pontoise Cedex | |
| France | Local Institution - 0100 | Rennes Cedex 9 | |
| France | Local Institution - 0140 | Strasbourg | |
| Germany | Local Institution - 0074 | Bamberg | |
| Germany | Local Institution - 0065 | Grosshansdorf | |
| Germany | Local Institution - 0064 | Heidelberg | |
| Germany | Local Institution - 0063 | Koeln | |
| Germany | Local Institution - 0066 | Stuttgart | |
| Germany | Local Institution - 0092 | Wiesbaden | |
| Greece | Local Institution - 0075 | Athens | |
| Greece | Local Institution - 0073 | Heraklion | Creta |
| Hungary | Local Institution - 0126 | Budapest | |
| Hungary | Local Institution - 0116 | Debrecen | |
| Hungary | Local Institution - 0094 | Matrahaza | |
| Italy | Local Institution - 0084 | Avellino | |
| Italy | Local Institution - 0079 | Livorno | |
| Italy | Local Institution - 0143 | Milano | |
| Italy | Local Institution - 0142 | Napoli | |
| Italy | Local Institution - 0083 | Perugia | |
| Italy | Local Institution - 0082 | Terni | |
| Japan | Local Institution - 0159 | Akashi, Hyogo | |
| Japan | Local Institution - 0154 | Chuo-ku | Tokyo |
| Japan | Local Institution - 0166 | Habikino-shi | Osaka |
| Japan | Local Institution - 0150 | Kitaadachi-gun | Saitama |
| Japan | Local Institution - 0153 | Kobe City | Hyogo |
| Japan | Local Institution - 0148 | Matsuyama-shi | Ehime |
| Japan | Local Institution - 0147 | Miyakojima-ku | Osaka |
| Japan | Local Institution - 0146 | Nagoya | Aichi |
| Japan | Local Institution - 0161 | Nagoya-shi | Aichi |
| Japan | Local Institution - 0144 | Natori-shi | Miyagi |
| Japan | Local Institution - 0151 | Niigata-shi | Niigata |
| Japan | Local Institution - 0145 | Osaka-sayama | Osaka |
| Japan | Local Institution - 0162 | Ota, Gunma | |
| Japan | Local Institution - 0152 | Sakai | Osaka |
| Japan | Local Institution - 0165 | Sapporo, Hokkaido | |
| Japan | Local Institution - 0149 | Sunto-gun | Shizuoka |
| Japan | Local Institution - 0160 | Tokyo | |
| Japan | Local Institution - 0158 | Wakayama | |
| Korea, Republic of | Local Institution - 0155 | Gangnam-gu | |
| Korea, Republic of | Local Institution - 0163 | Seoul | |
| Korea, Republic of | Local Institution - 0164 | Seoul | |
| Mexico | Local Institution - 0122 | Guadalajara | Jalisco |
| Mexico | Local Institution - 0124 | Merida | Yucatan |
| Mexico | Local Institution - 0117 | Mexico | Distrito Federal |
| Netherlands | Local Institution - 0045 | Amsterdam | |
| Netherlands | Local Institution - 0057 | Groningen | |
| Netherlands | Local Institution - 0046 | Rotterdam | |
| Poland | Local Institution - 0114 | Bydgoszcz | |
| Poland | Local Institution - 0131 | Krakow | |
| Poland | Local Institution - 0139 | Lodz | |
| Poland | Local Institution - 0089 | Warszawa | |
| Poland | Local Institution - 0093 | Wodzislaw Slaski | |
| Romania | Local Institution - 0068 | Cluj Napoca | |
| Romania | Local Institution - 0067 | Cluj-napoca | |
| Romania | Local Institution - 0069 | Ploiesti | |
| Spain | Local Institution - 0040 | Barcelona | |
| Spain | Local Institution - 0041 | Las Palmas De Gran Canaria | |
| Spain | Local Institution - 0047 | Madrid | |
| Spain | Local Institution - 0042 | Malaga | |
| Spain | Local Institution - 0039 | Sevilla | |
| Spain | Local Institution - 0043 | Valencia | |
| Sweden | Local Institution - 0127 | Stockholm | |
| Sweden | Local Institution - 0125 | Uppsala | |
| Switzerland | Local Institution - 0076 | Chur | |
| Switzerland | Local Institution - 0077 | Lausanne | |
| Switzerland | Local Institution - 0078 | Zuerich | |
| Taiwan | Local Institution - 0157 | Taipei | |
| Turkey | Local Institution - 0130 | Kayseri | |
| United Kingdom | Local Institution - 0053 | Leeds | Yorkshire |
| United Kingdom | Local Institution - 0098 | London | Greater London |
| United Kingdom | Local Institution - 0097 | Manchester | Greater Manchester |
| United States | Local Institution - 0007 | Allentown | Pennsylvania |
| United States | Local Institution - 0010 | Atlanta | Georgia |
| United States | University Of Colorado Hosp | Aurora | Colorado |
| United States | Local Institution - 0024 | Baltimore | Maryland |
| United States | Local Institution - 0036 | Boston | Massachusetts |
| United States | Local Institution - 0070 | Boston | Massachusetts |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina |
| United States | Local Institution - 0011 | Charleston | South Carolina |
| United States | Local Institution - 0037 | Chicago | Illinois |
| United States | Local Institution - 0012 | Cleveland | Ohio |
| United States | Local Institution - 0027 | Columbus | Ohio |
| United States | Local Institution - 0006 | Dallas | Texas |
| United States | Local Institution - 0003 | Durham | North Carolina |
| United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
| United States | Local Institution - 0038 | Greenville | South Carolina |
| United States | Local Institution - 0023 | Houston | Texas |
| United States | Local Institution - 0014 | Lexington | Kentucky |
| United States | Northwest Georgia Oncology Center, P.C. | Marietta | Georgia |
| United States | Crescent City Research Consortium, LLC | Marrero | Louisiana |
| United States | Local Institution - 0030 | Miami | Florida |
| United States | Southern Cancer Center, Inc. | Mobile | Alabama |
| United States | Local Institution - 0008 | Nashville | Tennessee |
| United States | Local Institution - 0020 | New Haven | Connecticut |
| United States | Local Institution - 0005 | New York | New York |
| United States | Local Institution - 0009 | New York | New York |
| United States | Local Institution - 0033 | Ocala | Florida |
| United States | Local Institution - 0002 | Philadelphia | Pennsylvania |
| United States | Local Institution - 0054 | Philadelphia | Pennsylvania |
| United States | Local Institution - 0018 | Pittsburgh | Pennsylvania |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Cancer Centers of South Texas | San Antonio | Texas |
| United States | Local Institution - 0016 | Stanford | California |
| United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
| United States | Local Institution - 0034 | Tucson | Arizona |
| United States | Local Institution - 0029 | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-Free Survival in Participants With PD-L1 Expression >= 5% | Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy. | From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months) | |
| Secondary | Progression-Free Survival in All Randomized Participants | Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy. | From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months) | |
| Secondary | Overall Survival in Participants With PD-L1 Expression >= 5% | Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up. | From date of randomization to date of death (up to approximately 89 months) | |
| Secondary | Overall Survival in All Randomized Participants | Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up. | From date of randomization to date of death (up to approximately 89 months) | |
| Secondary | Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5% | ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir. | From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months) | |
| Secondary | Disease-related Symptom Improvement Rate by Week 12 | The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12. | From date of randomization to week 12 |