Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti−PD-L1 Antibody) Compared With Docetaxel in Patients With Non−Small Cell Lung Cancer After Platinum Failure
Verified date | September 2019 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Status | Completed |
Enrollment | 287 |
Est. completion date | September 6, 2018 |
Est. primary completion date | November 19, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult participants, >/= 18 years of age - Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC) - Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens - Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen - Measurable disease, as defined by RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: - Known active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome - History of autoimmune disease - History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. - Active hepatitis B or hepatitis C - Prior treatment with docetaxel - Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven Gasthuisberg | Leuven | |
Belgium | Chr de La Citadelle | Liège | |
Canada | Cite de La Sante de Laval; Hemato-Oncologie | Laval | Quebec |
Canada | McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec |
France | Hopital Gabriel Montpied; Service de Pneumologie | Clermont-ferrand | |
France | Hôpital Nord Michallon; Pneumologie | La Tronche | |
France | Centre D'Oncologie de Gentilly; Oncology | Nancy | |
France | Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie | St Brieuc | |
France | Hopital Larrey; Pneumologie | Toulouse | |
Germany | Asklepios-Fachkliniken Muenchen-Gauting; Onkologie | Gauting | |
Germany | Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II | Halle | |
Germany | Fachklinik für Lungenerkrankungen | Immenhausen | |
Germany | Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie | Regensburg | |
Italy | Citta Ospedaliera; Divisione Oncologia Medica | Avellino | Campania |
Italy | Irccs Ospedale San Raffaele;Oncologia Medica | Milano | Lombardia |
Korea, Republic of | National Cancer Center; Medical Oncology | Gyeonggi-do | |
Korea, Republic of | Samsung Medical Centre; Division of Hematology/Oncology | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Poland | Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gdansk | |
Poland | Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii | Lodz | |
Poland | Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii | Otwock | |
Poland | Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii | Warszawa | |
Spain | Hospital La Paz | Madrid | |
Spain | Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | |
Spain | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | |
Spain | Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | |
Sweden | Universitetssjukhuset Linköping; Lungmedicinkliniken | Linköping | |
Thailand | Chulalongkorn Hospital; Medical Oncology | Bangkok | |
Thailand | Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | |
Thailand | Rajavithi Hospital; Division of Medical Oncology | Bangkok | |
Turkey | Akdeniz University Medical Faculty; Medical Oncology Department | Antalya | |
Turkey | Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | |
United Kingdom | Charing Cross Hospital; Medical Oncology. | London | |
United Kingdom | Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | |
United Kingdom | Royal Free Hospital; Dept of Oncology | London | |
United Kingdom | Christie Hospital Nhs Trust; Medical Oncology | Manchester | |
United States | New York Oncology Hematology, P.C. | Albany | New York |
United States | Georgia Cancer Specialists | Atlanta | Georgia |
United States | Texas Oncology - South Austin | Austin | Texas |
United States | Billings Clinic; Research Center | Billings | Montana |
United States | Broome Oncology - Binghamton | Binghamton | New York |
United States | Karmanos Cancer Institute.. | Detroit | Michigan |
United States | Willamette Valley Cancer Ctr - 520 Country Club | Eugene | Oregon |
United States | Virginia Cancer Specialists, PC | Fairfax | Virginia |
United States | Texas Oncology, P.A. - Fort Worth | Fort Worth | Texas |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Genesis Cancer Center | Hot Springs | Arkansas |
United States | Center for Biomedical Research LLC | Knoxville | Tennessee |
United States | Comprehensive Cancer Centers of Nevada - Eastern Avenue | Las Vegas | Nevada |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Rocky Mountain Cancer Centers - Colorado Springs (Circle) | Lone Tree | Colorado |
United States | Virginia Oncology Associates | Norfolk | Virginia |
United States | Ocala Oncology Center | Ocala | Florida |
United States | The Valley Hospital | Paramus | New Jersey |
United States | Illinois Cancer Care | Peoria | Illinois |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Blue Ridge Cancer Care | Roanoke | Virginia |
United States | Kaiser Permanente - San Marcos | San Marcos | California |
United States | New England Cancer Specialists | Scarborough | Maine |
United States | Arizona Oncology Associates, PC - HOPE | Tucson | Arizona |
United States | Kaiser Permanente - Vallejo | Vallejo | California |
United States | Northwest Cancer Specialists - Vancouver | Vancouver | Washington |
United States | Providence St. Mary Regional Cancer Center | Walla Walla | Washington |
United States | Wenatchee Valley Hospital & Clinics | Wenatchee | Washington |
United States | Innovative Clinical Research Institute | Whittier | California |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Belgium, Canada, France, Germany, Italy, Korea, Republic of, Poland, Spain, Sweden, Thailand, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive. | From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) | |
Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) | |
Secondary | Progression-Free Survival (PFS) | PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) | |
Secondary | Duration of Response (DOR) | DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first. | From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months) | |
Secondary | ORR (Modified RECIST) | ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months) | |
Secondary | PFS (Modified RECIST) | PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months) | |
Secondary | DOR (Modified RECIST) | DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first. | From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months) |
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