Squamous Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Verified date | March 2022 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.
Status | Completed |
Enrollment | 1021 |
Est. completion date | February 17, 2021 |
Est. primary completion date | October 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC - Previously obtained archival tumor tissue or tissue obtained from biopsy at screening - Measurable disease as defined by RECIST v1.1 - Adequate hematologic and end organ function Exclusion Criteria: - Active or untreated central nervous system (CNS) metastasis - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome - Pregnant or lactating women - History of autoimmune disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted - Positive test for Human Immunodeficiency Virus (HIV) - Active hepatitis B or hepatitis C - Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody - Severe infection within 4 weeks prior to randomization - Significant history of cardiovascular disease |
Country | Name | City | State |
---|---|---|---|
Argentina | Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | |
Argentina | Sanatorio Allende | Cordoba | |
Argentina | Centro Oncologico Riojano Integral (CORI) | La Rioja | |
Argentina | Clínica Pergamino | Pergamino | |
Argentina | Fundacion Koriza | Santa Rosa | |
Argentina | Centro de Investigacion; Clinica - Clinica Viedma S.A. | Viedma | |
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Chris O'Brien Lifehouse | Camperdown | New South Wales |
Australia | Prince Charles Hospital | Chermside | Queensland |
Australia | Austin Health | Heidelberg | Victoria |
Australia | Cabrini Hospital Malvern | Malvern | Victoria |
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | Sunshine Hospital | St Albans | Victoria |
Australia | Townsville Hospital | Townsville | Queensland |
Australia | Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Austria | Paracelsus Medizinische Privatuniversität | Salzburg | |
Belgium | Cliniques Universitaires St-Luc | Bruxelles | |
Belgium | CHU Sart-Tilman | Liège | |
Belgium | Clinique Ste-Elisabeth | Namur | |
Belgium | Werken Glorieux VZW | Ronse | |
Belgium | GasthuisZusters Antwerpen | Wilrijk | |
Brazil | *X*Fundação Pio XII Hospital de Câncer de Barretos | Barretos | SP |
Brazil | Cenantron - Centro Avancado de Tratamento Oncologico | Belo Horizonte | MG |
Brazil | IPCEM; Instituto de Pesquisa de Estudos Multicêntricos | Caxias do Sul | RS |
Brazil | Hospital Bruno Born | Lajeado | RS |
Brazil | Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica | Londrina | PR |
Brazil | Liga Norte Riograndense Contra O Câncer | Natal | RN |
Brazil | Hospital das Clinicas - UFRGS | Porto Alegre | RS |
Brazil | Hospital Mae de Deus | Porto Alegre | RS |
Brazil | Hospital de Base de Sao Jose do Rio Preto | Sao Jose do Rio Preto | SP |
Brazil | Hospital Do Cancer A C Camargo | Sao Paulo | SP |
Bulgaria | Multiprofile Hospital for Active Treatment Central Onco Hospital OOD | Plovdiv | |
Bulgaria | Multiprofile Hospital for Active Treatment Serdika EOOD | Sofia | |
Canada | Royal Victoria Regional Health Centre | Barrie | Ontario |
Canada | William Osler Health Centre | Etobicoke | Ontario |
Canada | Cite de La Sante de Laval; Hemato-Oncologie | Laval | Quebec |
Canada | Hôpital du Sacré-Coeur de Montreal | Montreal | Quebec |
Canada | Lakeridge Health Center | Oshawa | Ontario |
Canada | St. Jerome Medical Research | St. Jerome | Quebec |
Chile | Health & Care SPA | Santiago | |
Chile | Sociedad de Investigaciones Medicas Ltda (SIM) | Temuco | |
France | CHU de Grenoble | Grenoble | |
France | Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd | Le Mans | |
France | Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes | Lyon | |
France | Clinique Clémentville | Montpellier | |
France | Hopital de La Source | Orleans | |
France | Centre Hospitalier Lyon Sud | Pierre Benite | |
France | Hopital de Pontchaillou; Service de Pneumologie | Rennes | |
France | Centre Hospitalier Regional Sud Reunion; Service de Pneumologie | Saint Pierre | |
France | CH de Saint Quentin | Saint Quentin | |
France | Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques | Toulon Cedex 9 | |
Germany | Charite - Universitätsmedizin Berlin | Berlin | |
Germany | Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie | Bielefeld | |
Germany | Augusta Kranken-Anstalt gGmbH | Bochum | |
Germany | Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | |
Germany | St. Elisabethen Krankenhaus | Frankfurt am Main | |
Germany | Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie | Gerlingen | |
Germany | LungenClinic Großhansdorf GmbH | Großhansdorf | |
Germany | Krankenhaus Martha-Maria; Halle-Dolau gGmbH | Halle | |
Germany | Asklepios Klinik Harburg | Hamburg | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Lungenklinik Hemer | Hemer | |
Germany | Universität Des Saarlandes; Klinik für Innere Medizin V | Homburg | |
Germany | Fachklinik für Lungenerkrankungen | Immenhausen | |
Germany | Kliniken der Stadt Koln gGmbH | Koln | |
Germany | Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin | Minden | |
Germany | Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie | München | |
Germany | Klinikum der Universität Regensburg | Regensburg | |
Germany | Krankenhaus Barmherzige Bruder Regensburg | Regensburg | |
Germany | Stiftung Mathias-Spital Rheine | Rheine | |
Germany | Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie | Villingen-Schwenningen | |
Israel | Soroka Medical Center | Beer Sheva | |
Israel | Hadassah University Hospital - Ein Kerem | Jerusalem | |
Israel | Meir Medical Center; Oncology | Kfar-Saba | |
Israel | Rabin Medical Center | Petach Tiqwa | |
Israel | Chaim Sheba Medical Center; Oncology Dept | Ramat Gan | |
Israel | Rambam Health Corporation; Oncology Institute | Rambam | |
Israel | Tel Aviv Sourasky Medical Ctr; Oncology | Tel Aviv | |
Italy | Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati | Avellino | Campania |
Italy | IRCCS Giovanni Paolo II Istituto Oncologico | Bari | Puglia |
Italy | Policlinico Vittorio Emanuele | Catania | Sicilia |
Italy | ASL 3 Genovese; DSM | Genova | Liguria |
Italy | Ospedale Civile - Livorno | Livorno | Toscana |
Italy | AORN A Cardarelli | Napoli | Campania |
Italy | Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata | Napoli | Campania |
Italy | Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale | Napoli | Campania |
Italy | Fondazione IRCCS Policlinico San Matteo | Pavia | Lombardia |
Italy | Ospedale Silvestrini | Perugia | Umbria |
Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | Toscana |
Italy | Azienda Ospedaliera San Camillo Forlanini | Roma | Lazio |
Japan | Aichi Cancer Center Hospital; Respiratory Medicine | Aichi | |
Japan | Nagoya University Hospital; Respiratory Medicine | Aichi | |
Japan | National Cancer Center Hospital East; Thoracic Oncology | Chiba | |
Japan | National Hospital Organization Shikoku Cancer Center; Internal Medicine | Ehime | |
Japan | Kyushu University Hospital; Respiratory | Fukuoka | |
Japan | National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine | Fukuoka | |
Japan | Hyogo Cancer Center; Thoracic Oncology | Hyogo | |
Japan | Kobe City Medical Center General Hospital; Respiratory Medicine | Hyogo | |
Japan | National Hospital Organization Himeji Medical Center | Hyogo | |
Japan | Ibaraki Prefectural Central Hospital; Division of respiratory | Ibaraki | |
Japan | Kanagawa Cancer Center;Thoracic Oncology | Kanagawa | |
Japan | Kyoto University Hospital, Respiratory Medicine | Kyoto | |
Japan | Sendai Kousei Hospital; Pulmonary Medicine | Miyagi | |
Japan | Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease | Niigata | |
Japan | Okayama University Hospital; Respiratory and Allergy Medicine | Okayama | |
Japan | Kansai Medical university Hospital; Thoracic Oncology | Osaka | |
Japan | Osaka City Uni Hospital; Respiratory Medicine | Osaka | |
Japan | Osaka Habikino Medical Center | Osaka | |
Japan | Osaka International Cancer Institute; Thoracic Oncology | Osaka | |
Japan | National Hospital Organization Kinki-Chuo Chest Medical Center | Sakai-shi | |
Japan | Saitama Cancer Center; Thoracic Oncology | Satima | |
Japan | Shizuoka Cancer Center; Thoracic Oncology | Shizuoka | |
Japan | National Cancer Center Hospital; Thoracic Medical Oncology | Tokyo | |
Japan | Tokyo Medical University Hospital; Dept of Surgery | Tokyo | |
Latvia | Pauls Stradins Clinical University Hospital | Riga | |
Latvia | Riga East Clinical University Hospital Latvian Oncology Centre | Riga | |
Lithuania | National Cancer Institute | Vilnius | |
Mexico | Centro Universitario Contra El Cancer | Monterrey | |
Mexico | Cancerología | Queretaro | |
Netherlands | Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis | Amsterdam | |
Netherlands | VU Medisch Centrum; VU University Medical Center | Amsterdam | |
Netherlands | Ziekenhuis Gelderse Vallei | EDE | |
Netherlands | Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose | Eindhoven | |
Netherlands | St. Antonius Ziekenhuis; R&D Long | Nieuwegein | |
Peru | Centro Medico Monte Carmelo | Arequipa | |
Peru | Hospital Nacional Guillermo Almenara Irigoyen ESSALUD | Lima | |
Peru | Instituto Regional de Enfermedades Neoplásicas Del Norte | Trujillo | |
Portugal | Hospital Pulido Valente; Servico de Pneumologia | Lisboa | |
Portugal | IPO de Lisboa; Servico de Pneumologia | Lisboa | |
Portugal | Centro Hospitalar do Porto - Hospital de Santo António | Porto | |
Portugal | Hospital de Sao Joao; Servico de Pneumologia | Porto | |
Portugal | Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe | Porto | |
Russian Federation | Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moskovskaja Oblast |
Russian Federation | Russian Oncology Research Center n.a. N.N. Blokhin | Moscow | |
Russian Federation | Clinical Oncology Dispensary | Omsk | |
Russian Federation | City Clinical Oncology Dispensary | Saint-Petersburg | |
Russian Federation | Volgograd Regional Clinical Oncology Dispensary | Volgograd | |
Singapore | National Cancer Centre | Singapore | |
Singapore | National University Hospital | Singapore | |
Slovakia | Narodny onkologicky ustav | Bratislava | |
Slovakia | Univerzitna nemocnica Bratislava | Bratislava | |
Slovakia | POKO Poprad s.r.o. | Poprad | |
Spain | Complejo Hospitalario Universitario A Coruña | A Coruña | LA Coruña |
Spain | Hospital Clinic de Barcelona | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | |
Spain | Hospital Universitario Reina Sofia | Cordoba | |
Spain | Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia | L'Hospitalet de Llobregat | Barcelona |
Spain | Complejo Hospitalario Universitario Insular-Materno Infantil | Las Palmas de Gran Canaria | LAS Palmas |
Spain | Hospital Lucus Augusti; Servicio de Oncologia | Lugo | |
Spain | Fundación Jimenez Díaz | Madrid | |
Spain | Hospital Clinico San Carlos; Servicio de Oncologia | Madrid | |
Spain | HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia | Madrid | |
Spain | Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | |
Spain | Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Son Espases | Palma De Mallorca | Islas Baleares |
Spain | Hospital Universitario de Canarias | S. Cristobal De La Laguna | Tenerife |
Spain | Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona |
Spain | Hospital Universitario Marques de Valdecilla; Servicio de Oncologia | Santander | Cantabria |
Spain | Hospital Nuestra Senora de Valme | Seville | Sevilla |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
Spain | Hospital General Universitario de Valencia | Valencia | |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
Taiwan | Changhua Christian Hospital; Hematology-Oncology | Changhua | |
Taiwan | Kaohsiung Medical University Hospital; Department of Urology | Kaohsiung City | |
Taiwan | Chi Mei Medical Center Liou Ying Campus | Liuying Township | |
Taiwan | Chang Gung Memorial Hospital Chiayi | Putzu | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | Mackay Memorial Hospital | Taipei | |
Taiwan | National Taiwan Uni Hospital | Taipei City | |
Ukraine | Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1 | Chernivtsi | |
Ukraine | Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy | Dnipropetrovsk | Katerynoslav Governorate |
Ukraine | Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs | Kharkiv | Kharkiv Governorate |
Ukraine | SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine | Kharkiv | |
Ukraine | ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department | Kryvyi Rih | |
Ukraine | MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy | Lviv | Volhynian Governorate |
Ukraine | Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department | Poltava | |
Ukraine | Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary | Sumy | |
Ukraine | Uzhgorod Central City Clinical Hospital | Uzhhorod | Katerynoslav Governorate |
Ukraine | Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council | Vinnytsia | KIEV Governorate |
Ukraine | MNPE Zaporizhzhia Regional Antitumor Center ZRC | Zaporizhzhia | Katerynoslav Governorate |
United States | St. Joseph Mercy Health System | Ann Arbor | Michigan |
United States | University Cancer & Blood Center, LLC; Research | Athens | Georgia |
United States | Southern CA Permanente Med Grp | Bellflower | California |
United States | St. Luke's Cancer Care Associates | Bethlehem | Pennsylvania |
United States | Hematology-Oncology; Associates of the Quad Cities | Bettendorf | Iowa |
United States | Billings Clinic | Billings | Montana |
United States | Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Carrollton | Georgia |
United States | Ironwood Cancer & Research Centers | Chandler | Arizona |
United States | SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee |
United States | University of Chicago | Chicago | Illinois |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Mark H. Zangmeister Center | Columbus | Ohio |
United States | Danbury Hospital | Danbury | Connecticut |
United States | SCRI The Center For Cancer and Blood Disorders | Denton | Texas |
United States | Rocky Mountain Cancer Center | Denver | Colorado |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | St. Luke's Regional Cancer Center | Duluth | Minnesota |
United States | Providence Regional Cancer Partnership | Everett | Washington |
United States | Virginia Cancer Specialists, PC | Fairfax | Virginia |
United States | Southcoast Health System; Southcoast Centers For Cancer Care | Fairhaven | Massachusetts |
United States | Holy Cross Hospital Inc | Fort Lauderdale | Florida |
United States | SCRI Florida Cancer Specialists South | Fort Myers | Florida |
United States | Fort Wayne Med Oncology & Hematology Inc | Fort Wayne | Indiana |
United States | Maryland Oncology Hematology (Lanham) - USOR | Gettysburg | Pennsylvania |
United States | Oncology Hematology Care, Inc. | Hamilton | Ohio |
United States | Joliet Oncology-Hematology; Associates, Ltd. | Joliet | Illinois |
United States | Tennessee Cancer Specialists | Knoxville | Tennessee |
United States | Lahey Clinic Med Ctr | Lexington | Kentucky |
United States | Longview Cancer Center | Longview | Texas |
United States | Norton Cancer Institute | Louisville | Kentucky |
United States | Central Georgia Cancer Care PC | Macon | Georgia |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Southeastern Regional Medical Center, Inc. | Newnan | Georgia |
United States | Virginia Oncology Associates | Norfolk | Virginia |
United States | Kaiser Permanente Oakland Medical Center | Oakland | California |
United States | Florida Cancer Specialists | Palm Beach Gardens | Florida |
United States | Valley Hospital; Oncology Research | Paramus | New Jersey |
United States | Allegheny Cancer Center | Pittsburgh | Pennsylvania |
United States | Univ of Pittsburgh Medical Ctr | Pittsburgh | Pennsylvania |
United States | Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida |
United States | Oregon Health & Science Uni | Portland | Oregon |
United States | Quincy Medical Group | Quincy | Illinois |
United States | Blue Ridge Cancer Care | Roanoke | Virginia |
United States | Kaiser Permanente - Sacramento Medical Center and Medical Offices | Sacramento | California |
United States | Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) | Saint Petersburg | Florida |
United States | W.G. Bill Hefner VA Medical Center | Salisbury | North Carolina |
United States | Kaiser Permanente - San Leandro Medical Center | San Leandro | California |
United States | Kaiser Permanente - Santa Clara | Santa Clara | California |
United States | New England Cancer Specialists | Scarborough | Maine |
United States | Regional Cancer Care Associates LLC | Sewell | New Jersey |
United States | Siouxland Hematology/Oncology | Sioux City | Iowa |
United States | Medical Oncology Associates | Spokane | Washington |
United States | Highlands Oncology Group | Springdale | Arkansas |
United States | Hematology and Oncology Associates at Bridgepoint | Tupelo | Mississippi |
United States | Kaiser Permanente; Oncology Clinical Trials | Vallejo | California |
United States | Kaiser Permanente - Walnut Creek | Walnut Creek | California |
United States | Clinical Research Alliance | Westbury | New York |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, France, Germany, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Peru, Portugal, Russian Federation, Singapore, Slovakia, Spain, Taiwan, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population. | Up to approximately 30 months after first participant enrolled | |
Primary | Overall Survival (OS) in the ITT Population | OS is defined as the time between the date of randomization and date of death from any cause in the ITT population. | Up to approximately 39 months after first participant enrolled | |
Secondary | OS in the in the Teff Population | OS is defined as the time between the date of randomization and date of death from any cause in the in the Teff Population. | Up to approximately 39 months after first participant enrolled | |
Secondary | PFS as Determined by the Investigator Using RECIST v1.1 in the Teff Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Teff Population. | Up to approximately 30 months after first participant enrolled | |
Secondary | PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population. | Up to approximately 30 months after first participant enrolled | |
Secondary | PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the TC1/2/3 or IC1/2/3 Population. | Up to approximately 30 months after first participant enrolled | |
Secondary | OS in the TC2/3 or IC2/3 Population | OS is defined as the time between the date of randomization and date of death from any cause, in the TC2/3 or IC2/3 Population. | Up to approximately 39 months after first participant enrolled | |
Secondary | OS in the TC1/2/3 or IC1/2/3 Population | OS is defined as the time between the date of randomization and date of death from any cause in the TC1/2/3 or IC1/2/3 Population. | Up to approximately 39 months after first participant enrolled | |
Secondary | Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population | Proportion of participants with an objective response (CR or PR) in the ITT population. | Up to approximately 30 months after first participant enrolled | |
Secondary | Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population | Duration of response is defined as the time from the first documented objective response to documented PD or death from any cause, whichever occurred first, in the ITT Population. | Up to approximately 30 months after first participant enrolled | |
Secondary | Event Free Rate at 1 and 2 Years in the ITT Population | Event free rate at 1 and 2 years is defined as the proportion of participants alive at 1 and 2 years after randomization estimated using Kaplan-Meier (KM) methodology for the ITT population. | 1 and 2 years | |
Secondary | Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population | TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population. The EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC scales and single-item measures will be linearly transformed so that each score has a range of 0-100. A high score for a functional scale represents a high or healthy level of functioning, and a high score for the global health status and HRQoL represents a high HRQoL; however, a high score for a symptom scale or item represents a high level of symptomatology or problems. | Up to approximately 30 months after first participant enrolled | |
Secondary | TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population | TTD was documented for a 3-symptom composite endpoint using the following EORTC QLQ-LC13 symptom scores: cough, chest pain, and dyspnea multi--item scale. In this instance, symptom deterioration will be determined as a >= 10-point increase above baseline in any of the listed symptom scores, whichever occurs first (cough, chest pain, and dyspnea multi-item scale). Confirmed clinically meaningful symptom deterioration will need to be held for the original symptom; a >= 10-point increase above baseline in a symptom score must be held for at least two consecutive assessments or an initial>=10-point increase above baseline followed by death within 3 weeks from the last assessment. A >= 10-point change in the EORTC scale score is perceived by patients as clinically significant. | Up to approximately 30 months after the first participant enrolled | |
Secondary | Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population | Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of =0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of =0.5 points for chest pain score is considered to be clinically significant. (Note: PD=progression of disease) | Baseline up to approximately 30 months after first participant enrolled | |
Secondary | PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A and Arm B) | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT Population Arm A and Arm B. | Up to approximately 30 months after first participant enrolled | |
Secondary | OS in the ITT Population (Arm A and Arm B) | OS is defined as the time between the date of randomization and date of death from any cause in the ITT Population, Arm A and Arm B. | Up to approximately 39 months after first participant enrolled | |
Secondary | Percentage of Participants With Adverse Events | Percentage of participants with at least one adverse event. | Up to approximately 68 months after first participant enrolled | |
Secondary | Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab | Percentage of participants with Anti-therapeutic Antibody (ATA) response to atezolizumab. | Up to approximately 30 months after first participant enrolled | |
Secondary | Maximum Observed Serum Atezolizumab Concentration (Cmax) | Maximum observed serum atezolizumab concentration (Cmax). The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes. | Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days) | |
Secondary | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Minimum observed serum atezolizumab concentration (Cmin). The predose samples will be collected on the same day of treatment administration. | Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 30 months), at treatment discontinuation (up to 30 months), and at 120 days after the last dose of atezolizumab (up to approximately 30 months, each cycle is 21 days) | |
Secondary | Plasma Concentrations for Paclitaxel | Plasma concentrations for paclitaxel. | Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 180 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) | |
Secondary | Plasma Concentrations for Nab-Paclitaxel | Plasma concentrations for nab-paclitaxel. | Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) | |
Secondary | Plasma Concentrations for Carboplatin | Plasma concentrations for carboplatin. | Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 15 to 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03542461 -
Early Switch Maintenance vs Delayed Second-line Nivolumab in Advanced Stage Squamous Non-small Cell Lung Cancer (NSCLC) Patients (EDEN Trial)
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NCT04073537 -
Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
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Phase 3 | |
Completed |
NCT03717155 -
Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC
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Phase 2 | |
Terminated |
NCT02204345 -
A Study Evaluating RO5479599 in Combination With Carboplatin and Paclitaxel in Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histology
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Phase 1/Phase 2 | |
Terminated |
NCT01911325 -
Phase II Study of Buparlisib + Docetaxel in Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) Patients
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Phase 1 | |
Withdrawn |
NCT02924233 -
Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
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Phase 1/Phase 2 | |
Withdrawn |
NCT03319316 -
Combination of Durvalumab and Tremelimumab as Maintenance Treatment in Patients With Non Squamous and Squamous (NSCLC)
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Phase 2 | |
Completed |
NCT04552535 -
A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung
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Completed |
NCT01763788 -
A Study of Necitumumab in the First-Line Treatment of Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
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Phase 1/Phase 2 | |
Not yet recruiting |
NCT05879484 -
Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS
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Phase 1/Phase 2 | |
Recruiting |
NCT04149691 -
Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
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Phase 1 | |
Recruiting |
NCT05243355 -
Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Sq-NSCLC
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Phase 2 | |
Completed |
NCT03366480 -
A Study to Assess the Efficacy and Safety of ABTL0812
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Phase 1/Phase 2 | |
Not yet recruiting |
NCT04266730 -
Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab
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Phase 1 | |
Terminated |
NCT02109016 -
A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations
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Phase 2 | |
Completed |
NCT02106546 -
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
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Phase 3 | |
No longer available |
NCT02475382 -
Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen
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