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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02367794
Other study ID # GO29437
Secondary ID 2014-003208-59
Status Completed
Phase Phase 3
First received
Last updated
Start date June 11, 2015
Est. completion date February 17, 2021

Study information

Verified date March 2022
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody
Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.
Carboplatin
Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.
Nab-Paclitaxel
Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.
Paclitaxel
Paclitaxel 200 mg/m^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m^2 IV.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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, 

Outcome

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)
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