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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504209-35-00 | Registry Identifier | CTIS (EU) |
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This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Atezolizumab + platinum-based chemotherapy | Experimental | Neoadjuvant treatment will consist of 4 cycles; atezolizumab + platinum-based chemotherapy Platinum-based chemotherapy may include:
Post-operative adjuvant treatment will consist of 16-cycles of atezolizumab |
|
| Arm B: Placebo + platinum-based chemotherapy | Placebo Comparator | Neoadjuvant treatment will consist of 4 cycles; placebo + platinum-based chemotherapy Platinum-based chemotherapy may include:
Participants will receive best supportive care and monitoring after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody | Drug | Atezolizumab will be administered as intravenous (IV) infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle (every 3 weeks) for 4 cycles during the neoadjuvant treatment phase Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) every 3 weeks for 16 cycles during the post-operative adjuvant phase |
| Measure | Description | Time Frame |
|---|---|---|
| Independent Review Facility (IRF)-Assessed Event Free Survival (EFS) | IRF-assessed EFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 that precludes surgery, local or distant disease recurrence, or death from any cause, whichever occurs first. | Up to approximately 96 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) | pCR is defined as the absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes as assessed by central and local pathology laboratory. | At time of surgery |
| Major Pathological Response (MPR) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology | Tucson | Arizona | 85711 | United States | ||
| USC Norris Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33661301 | Derived | Romero Roman A, Campo-Canaveral de la Cruz JL, Macia I, Escobar Campuzano I, Figueroa Almanzar S, Delgado Roel M, Galvez Munoz C, Garcia Fontan EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martinez Tellez E, Partida Gonzalez C, Jimenez Lopez MF, Jimenez Maestre U, Mongil Poce R, Sanchez Lorente D, Alvarez Kindelan A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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|
|
| Placebo Comparator | Drug | Placebo will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase |
|
| Nab-paclitaxel | Drug | Nab-paclitaxel 100 mg/m^2 will be administered intravenously on Days 1, 8, and 15 of each 21 day cycle for 4 cycles during the neoadjuvant treatment phase |
|
|
| Pemetrexed | Drug | Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase |
|
|
| Carboplatin | Drug | Carboplatin initial target AUC of 6 mg/mL/min will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase |
|
| Cisplatin | Drug | Cisplatin 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase |
|
| Gemcitabine | Drug | Gemcitabine 1250 mg/m^2 will be administered intravenously on Day 1 and 8 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase |
|
|
MPR is defined as ≤ 10% residual viable tumor cells at the time of surgical resection in the primary tumor, as assessed by central and local pathology laboratory. |
| At time of surgery |
| Objective Response (OR) | Objective response is defined as a complete response or partial response, as determined by the investigator according to RECIST v1.1 | Prior to surgery, up to approximately 84 days |
| Overall Survival (OS) | OS is defined as the time from randomization to death from any cause during the course of the study. | Up to approximately 96 months |
| Investigator-Assessed EFS | EFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 that precludes surgery, local or distant disease recurrence, as assessed by the investigator; or death from any cause, whichever occurs first. | Up to approximately 96 months |
| Disease-Free Survival (DFS) | DFS is defined as the time from the first date of no disease to local or distant recurrence (including occurrence of new primary NSCLC) or death due to any cause, whichever occurs first, as determined by the investigator during the adjuvant treatment and observation follow-up | Up to approximately 96 months |
| 2-Year and 3-Year OS | The 2-year and 3-year OS rate is defined as the probability that a participant will be alive 2 years and 3 years after randomization, respectively. | Up to approximately 96 months |
| 2-Year and 3-Year Independent Review Facility-Assessed EFS | EFS is defined as the probability that a participant will be event-free 2 years and 3 years after randomization, respectively, as assessed by the Independent Review Facility. | Up to approximately 96 months |
| 2-Year and 3-Year Investigator-Assessed EFS | EFS is defined as the probability that a participant will be event-free 2 years and 3 years after randomization, respectively, as assessed by the Investigator. | Up to approximately 96 months |
| Change from baseline in HRQoL scores | Change from baseline in HRQoL scores as assessed through use of the two-item GHS/HRQoL subscale (Questions 29 and 30) of the EORTC QLQ-C30 at each assessment time point during the study through the completion of adjuvant treatment and observation follow-up assessments | Up to approximately 96 months |
| Percentage of Participants With Adverse Events (AEs) | Up to approximately 96 months |
| Number and Severity of Surgical Related Adverse Events | Up to approximately 96 months |
| Number of Surgical Delays | Number of surgical delays. | Up to approximately 96 months |
| Length of Surgical Delays | Length of surgical delays. | Up to approximately 96 months |
| Number of Operative and Post-Operative Complications | Number of operative and post-operative complications. | Up to approximately 96 months |
| Reasons for Surgical Cancellations | Reasons for surgical cancellations. | Up to approximately 96 months |
| Minimum Observed Serum Atezolizumab Concentration (Cmin) | Cmin is the minimum (or trough) concentration that a study drug achieves in the body. | Pre-dose on Day 1 of Cycles 1 and 3 (each cylce is 21 days) for Neoadjuvant Treatment; pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 (each cycle is 21 days) for Arm A; at treatment or observation follow-up discontinuation (up to approximately 96 months) |
| Maximum Observed Serum Atezolizumab Concentration (Cmax) | Cmax is the maximum (or peak) concentration that a study drug achieves in the body. | Pre-dose on Day 1 of Cycles 1 and 3 for Neoadjuvant Treatment; Pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 for Arm A. Each cycle is 21 days; at treatment or observation follow-up discontinuation (up to approximately 96 months) |
| Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab | Pre-dose on Day 1 of Cycles 1 and 3 for Neoadjuvant Treatment; Pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 for Arm A. Each cycle is 21 days; at treatment or observation follow-up discontinuation (up to approximately 96 months) |
| Los Angeles |
| California |
| 90033 |
| United States |
| The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange | Orange | California | 92868 | United States |
| UC Davis Cancer Center | Sacramento | California | 95817 | United States |
| Scripps Clinic | San Diego | California | 92037 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Washington Cancer Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| Uni of Maryland Cancer Center | Baltimore | Maryland | 21201 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Brighton Center for Specialty Care | Brighton | Michigan | 48116 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Minnesota Oncology Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Mercy Clinic Cancer & Hematology | Springfield | Missouri | 65804 | United States |
| Nebraska Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| NYU Winthrop Hospital | Mineola | New York | 11501 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Texas Oncology - South Austin | Austin | Texas | 78745 | United States |
| UT Health East Texas HOPE Cancer Center | Tyler | Texas | 75701 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Northwest Cancer Specialists - Vancouver | Vancouver | Washington | 98684 | United States |
| St George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Peter MacCallum Cancer Center | Melbourne | Victoria | 3000 | Australia |
| Kepler Universitätskliniken GmbH - Med Campus III | Linz | 4020 | Austria |
| Ordensklinikum Linz Elisabethinen | Linz | 4020 | Austria |
| Klinik Penzing | Vienna | 1140 | Austria |
| Krankenhaus Nord - Klinik Floridsdorf | Vienna | 1210 | Austria |
| Cenantron - Centro Avancado de Tratamento Oncologico | Belo Horizonte | Minas Gerais | 30130-090 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Shanghai Chest Hospital | Shanghai | 200030 | China |
| CHU Angers | Angers | 49933 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Hopital d'Instruction des Armees de Begin | Saint-Mandé | 94160 | France |
| Centre Hospitalier Saint Quentin | Saint-Quentin | 02321 | France |
| CHU Strasbourg - Nouvel Hopital Civil | Strasbourg | 67091 | France |
| Hôpital d'Instruction des Armées de Sainte Anne | Toulon | 83000 | France |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Asklepios-Fachkliniken Muenchen-Gauting | Gauting | 82131 | Germany |
| LungenClinic Großhansdorf GmbH | Großhansdorf | 22927 | Germany |
| Krankenhaus Martha-Maria Halle-Doelau gGmbH | Halle | 06120 | Germany |
| Pius-Hospital Oldenburg | Oldenburg | 26121 | Germany |
| Klinikum der Univer Regenburg | Regensburg | 93053 | Germany |
| Robert Bosch Krankenhaus | Stuttgart | 70376 | Germany |
| Missionsärztliche Klinik, Gemeinnützige Gesellschaft mbH | Würzburg | 97074 | Germany |
| Semmelweis Egyetem X | Budapest | 1083 | Hungary |
| Soroka Medical Center | Beersheba | 8410101 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Sourasky / Ichilov Hospital | Tel Aviv | 6423906 | Israel |
| Policlinico Universitario Campus Biomedico | Rome | Lazio | 00128 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int) | Milan | Lombardy | 20133 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO) | Milan | Lombardy | 20141 | Italy |
| A.O. Universitaria Pisana-Ospedale Cisanello | Pisa | Tuscany | 56124 | Italy |
| IOV - Istituto Oncologico Veneto - IRCCS | Padova | Veneto | 35128 | Italy |
| Aichi Cancer Center Hospital | Aichi | 464-8681 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | 730-8518 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Kobe University Hospital | Hyōgo | 650-0017 | Japan |
| Hyogo Medical University Hospital | Hyōgo | 663-8501 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Fukushima Medical University Hospital | Miyagi | 960-1295 | Japan |
| Sendai Kousei Hospital | Miyagi | 981-0914 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Kurashiki Central Hospital | Okayama | 710-8602 | Japan |
| Osaka City General Hospital | Osaka | 534-0021 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Juntendo University Hospital | Tokyo | 113-8431 | Japan |
| Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital | Tokyo | 113-8677 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Uniwersyteckie Centrum Kliniczne | Gda?sk | 80-214 | Poland |
| Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II | Krakow | 31-202 | Poland |
| Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad | Warsaw | 02-781 | Poland |
| Main Military Clinical Hospital named after N.N. Burdenko | Moscow | Moscow Oblast | 105229 | Russia |
| FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF | Moscow | Moscow Oblast | 115478 | Russia |
| S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Scientific Research Oncology Institute named after N.N. Petrov | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| University Hospital Medical Center Bezanijska kosa | Belgrade | 11080 | Serbia |
| University Clinic Golnik | Golnik | 4204 | Slovenia |
| Medical Oncology Centre of Rosebank | Johannesburg | 2196 | South Africa |
| Eugene Marais Hospital | Pretoria | South Africa |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital de Basurto | Bilbao | Vizcaya | 48013 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Regional Universitario Carlos Haya | Málaga | 29010 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitario la Fe | Valencia | 46026 | Spain |
| Lungmedicinska kliniken, Centrum för kirurgi, ortopedi och cancervård, Universitetssjukhuset | Linköping | 58185 | Sweden |
| Uni Hospital in Lund | Lund | 22185 | Sweden |
| Karolinska Universitetssjukhuset, Solna | Solna | 171 64 | Sweden |
| Uppsala University Hospital | Uppsala | SE-75185 | Sweden |
| CHUV | Lausanne | 1011 | Switzerland |
| UniversitätsSpital Zürich | Zurich | 8091 | Switzerland |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 00833 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Taichung Veterans General Hospital | Xitun Dist. | 40705 | Taiwan |
| Chulalongkorn Hospital | Bangkok | 10330 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | 50200 | Thailand |
| Chemotherapy SI Dnipropetrovsk MA of MOHU | Dnipropetrovsk | 49102 | Ukraine |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Barts and the London NHS Trust. | London | EC1A 7BE | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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