Epithelioid Mesothelioma Clinical Trial
Official title:
A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed With Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma
Verified date | March 2024 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and surgery with or without radiation therapy works in treating patients with stage I-III pleural malignant mesothelioma. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab, pemetrexed disodium, and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving atezolizumab after surgery may kill any remaining tumor cells.
Status | Active, not recruiting |
Enrollment | 28 |
Est. completion date | September 21, 2024 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - STEP 1: NEOADJUVANT - Patient must have stage I-III malignant pleural mesothelioma that is deemed resectable and must be planning to undergo pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP) - Patient must have epithelioid or biphasic histology (sarcomatoid histology is excluded); histologic diagnosis and typing of mesothelioma requires at least a core needle biopsy or surgical biopsy of the pleura via thoracoscopy and small thoracotomy; cytology only will not be regarded as sufficient for the diagnosis - Patient must have computed tomography (CT) chest/abdomen/pelvis with contrast or fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT scan performed within 28 days prior to step 1 registration - Patients must have non-measurable or measurable disease documented by CT or magnetic resonance imaging (MRI); the CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to step 1 registration; non-measurable disease must be assessed within 42 days prior to step 1 registration; all disease must be assessed and documented on the RECIST 1.1 and modified RECIST baseline tumor assessment form - Patient must have undergone extended surgical staging including mediastinoscopy or endobronchial ultrasound; at minimum, samples must be obtained from the mediastinal stations 4R, 7 (subcarinal), and 4L; this surgical staging must be performed within 42 days prior to step 1 registration; patient must be T1-3 and N0-N2 (single station) - Patient must undergo video-assisted thoracoscopic surgery and diagnostic laparoscopy within 28 days prior to step 1 registration to rule out peritoneal disease spread - Patient must have consultation with a surgeon within 21 days prior to step 1 registration; the surgeon must confirm that the patient's disease is resectable by pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP) and that the patient is an appropriate candidate for the surgical procedures - Patient must not have had prior immunotherapy or chemotherapy for malignant pleural mesothelioma - Patient must have Zubrod performance status 0 or 1 documented within 28 days prior to step 1 registration - Patients requiring hearing aids or reporting hearing loss must have audiogram performed within 28 days prior to step 1 registration - Patient must have not had any major surgery or radiation within 28 days prior to step 1 registration; diagnostic thoracotomies and laparoscopies are not considered major surgeries - Patients must not have any anticancer therapy or investigational agent within 28 days prior to step 1 registration - Absolute neutrophil count (ANC) >= 1,500/mcl (documented within 28 days prior to step 1 registration) - Hemoglobin >= 9 g/dl (documented within 28 days prior to step 1 registration) - Platelets >= 100,000/mcl (documented within 28 days prior to step 1 registration) - Creatinine =< 1.5 x upper limit of normal (ULN) (documented within 28 days prior to step 1 registration) - Creatinine clearance >= 45 ml/min (documented within 28 days prior to step 1 registration) - Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 28 days prior to step 1 registration) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 28 days prior to step 1 registration) - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years - Patients must not be pregnant or nursing due to the potential teratogenic side effects of the protocol treatment; women of reproductive potential and men must have agreed to use an effective contraceptive method for the duration of study treatment and for 5 months (150 days) after the last dose of atezolizumab; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures - Patient must NOT have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Patient must NOT have a known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation - Patients must not have severe infections within 28 days prior to step 1 registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia - Patients must not have active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; this protocol includes an immunotherapy agent which can precipitate known autoimmune diseases - Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation - Patient must not have active tuberculosis - Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis; this protocol includes an immunotherapy agent which can precipitate known pneumonitis - Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection as evidenced by testing performed within 28 days prior to registration; patients with past or resolved HBV infection are eligible; active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test; past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test; patient must not have active hepatitis C virus (HCV) infection as evidenced by testing performed within 28 days prior to registration; active HCV is defined as having a positive HCV antibody test followed by a positive HCV RNA test - Patient must NOT have a known positive test for human immunodeficiency virus (HIV); patients do not need to be screened for HIV; patients with HIV are excluded due to a potential incompetent immune system and need for medications that could interfere with the treatment and immunotherapy - Patient must not have significant cardiovascular disease, such as New York Heart Association cardiac disease (class II or greater), myocardial infarction within 3 months prior to initiation of treatment, unstable arrhythmias, or unstable angina given the higher risks associated with surgical resection - Patient must not receive live, attenuated influenza vaccine within 4 weeks prior to registration or at any time during the study and until 5 months after the last dose of atezolizumab - Patient must be willing to have tissue specimens submitted for translational medicine studies - Patient must be offered the opportunity to participate in tissue and blood banking for future studies - Patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - As a part of the Oncology Patient Enrollment Network (OPEN) registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - STEP 2: SURGERY - Patient must have a CT of chest/abdomen with contrast or FDG-PET/CT scan within 28 days prior to step 2 registration; patients must not have evidence of progression per RECIST 1.1 or modified RECIST for pleural tumors - Patients planning to receive EPP must also be evaluated for appropriateness of radiation therapy (RT) by a radiation oncologist within 14 days prior to step 2 registration - Patients must have a Zubrod performance status of 0-1 documented within 28 days prior to step 2 registration - Patients must have postoperative predicted forced expiratory volume in 1 second (FEV1) > 35% prior to surgery obtained within 28 days prior to step 2 registration; pulmonary function tests to ascertain these values must be obtained within 28 days prior to Step 2 registration - Patients must have postoperative predicted carbon monoxide diffusing capability (DLCO) > 35% prior to surgery obtained within 28 days prior to step 2 registration; pulmonary function tests to ascertain these values must be obtained within 28 days prior to Step 2 registration - Patient must have received at least two cycles of triplet neoadjuvant therapy (all three drugs) during step 1 - Patient must be registered to step 2 no less than 21 days and no more than 90 days after the end of their final cycle of neoadjuvant therapy - STEP 3: MAINTENANCE - Patient must have received either P/D or EPP and must have recovered from all effects of surgery with adequate wound healing; patients who received radiation therapy (RT) must be registered to step 3 within 90 days after discontinuing RT; patients who did not receive RT must be registered to step 3 within 90 days after surgery - Patient must have a CT of chest/abdomen/pelvis with contrast or FDG-PET/CT scan within 28 days prior to step 3 registration; patient must not have evidence of progression per RECIST 1.1 or modified RECIST for pleural tumors - Patient may have discontinued RT early due to toxicity or other reasons - Patients must have a Zubrod performance status of 0-1 documented within 28 days prior to step 3 registration - ANC > 1,500/mcl (documented within 28 days prior to step 3 registration) - Hemoglobin > 9 g/dl (documented within 28 days prior to step 3 registration) - Platelets > 100,000/mcl (documented within 28 days prior to step 3 registration) - Creatinine < 1.5 x ULN (documented within 28 days prior to step 3 registration) - Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 28 days prior to step 3 registration) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 28 days prior to step 3 registration) |
Country | Name | City | State |
---|---|---|---|
United States | Mary Greeley Medical Center | Ames | Iowa |
United States | McFarland Clinic - Ames | Ames | Iowa |
United States | Community Hospital of Anaconda | Anaconda | Montana |
United States | PCR Oncology | Arroyo Grande | California |
United States | Rush - Copley Medical Center | Aurora | Illinois |
United States | Flaget Memorial Hospital | Bardstown | Kentucky |
United States | Overlake Medical Center | Bellevue | Washington |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Parkland Health Center-Bonne Terre | Bonne Terre | Missouri |
United States | McFarland Clinic - Boone | Boone | Iowa |
United States | Bozeman Health Deaconess Hospital | Bozeman | Montana |
United States | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington |
United States | Henry Ford Cancer Institute-Downriver | Brownstown | Michigan |
United States | Saint Joseph Regional Cancer Center | Bryan | Texas |
United States | Highline Medical Center-Main Campus | Burien | Washington |
United States | Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho |
United States | Illinois CancerCare-Canton | Canton | Illinois |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Memorial Hospital of Carbondale | Carbondale | Illinois |
United States | SIH Cancer Institute | Carterville | Illinois |
United States | Illinois CancerCare-Carthage | Carthage | Illinois |
United States | Centralia Oncology Clinic | Centralia | Illinois |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Virginia Cancer Center | Charlottesville | Virginia |
United States | Memorial Hospital | Chattanooga | Tennessee |
United States | Bethesda North Hospital | Cincinnati | Ohio |
United States | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio |
United States | TriHealth Cancer Institute-Anderson | Cincinnati | Ohio |
United States | TriHealth Cancer Institute-Westside | Cincinnati | Ohio |
United States | Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan |
United States | Mercy Cancer Center-West Lakes | Clive | Iowa |
United States | Mission Cancer and Blood - West Des Moines | Clive | Iowa |
United States | Billings Clinic-Cody | Cody | Wyoming |
United States | Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado |
United States | MD Anderson in The Woodlands | Conroe | Texas |
United States | Commonwealth Cancer Center-Corbin | Corbin | Kentucky |
United States | Alegent Health Mercy Hospital | Council Bluffs | Iowa |
United States | Greater Regional Medical Center | Creston | Iowa |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Carle at The Riverfront | Danville | Illinois |
United States | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Mission Cancer and Blood - Laurel | Des Moines | Iowa |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Mercy Medical Center | Durango | Colorado |
United States | Southwest Oncology PC | Durango | Colorado |
United States | Carle Physician Group-Effingham | Effingham | Illinois |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Saint Elizabeth Hospital | Enumclaw | Washington |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | Saint Francis Hospital | Federal Way | Washington |
United States | McFarland Clinic - Trinity Cancer Center | Fort Dodge | Iowa |
United States | Illinois CancerCare-Galesburg | Galesburg | Illinois |
United States | Western Illinois Cancer Treatment Center | Galesburg | Illinois |
United States | Mountain Blue Cancer Care Center | Golden | Colorado |
United States | Nebraska Cancer Specialists/Oncology Hematology West PC | Grand Island | Nebraska |
United States | Benefis Sletten Cancer Institute | Great Falls | Montana |
United States | Great Falls Clinic | Great Falls | Montana |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada |
United States | OptumCare Cancer Care at Seven Hills | Henderson | Nevada |
United States | Pulmonary Medicine Center of Chattanooga-Hixson | Hixson | Tennessee |
United States | CHI Saint Vincent Cancer Center Hot Springs | Hot Springs | Arkansas |
United States | Lyndon Baines Johnson General Hospital | Houston | Texas |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | MD Anderson West Houston | Houston | Texas |
United States | Allegiance Health | Jackson | Michigan |
United States | Baptist MD Anderson Cancer Center | Jacksonville | Florida |
United States | McFarland Clinic - Jefferson | Jefferson | Iowa |
United States | MU Health Care Goldschmidt Cancer Center | Jefferson City | Missouri |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | CHI Health Good Samaritan | Kearney | Nebraska |
United States | Heartland Hematology and Oncology | Kearney | Nebraska |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado |
United States | Saint Anthony Hospital | Lakewood | Colorado |
United States | Saint Clare Hospital | Lakewood | Washington |
United States | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada |
United States | GenesisCare USA - Las Vegas | Las Vegas | Nevada |
United States | OptumCare Cancer Care at Charleston | Las Vegas | Nevada |
United States | OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada |
United States | OptumCare Cancer Care at MountainView | Las Vegas | Nevada |
United States | Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada |
United States | Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Cancer Centers of Southwest Oklahoma Research | Lawton | Oklahoma |
United States | MD Anderson League City | League City | Texas |
United States | Saint Joseph Hospital East | Lexington | Kentucky |
United States | Saint Joseph Radiation Oncology Resource Center | Lexington | Kentucky |
United States | Saint Elizabeth Regional Medical Center | Lincoln | Nebraska |
United States | Littleton Adventist Hospital | Littleton | Colorado |
United States | Saint Joseph London | London | Kentucky |
United States | Longmont United Hospital | Longmont | Colorado |
United States | Rocky Mountain Cancer Centers-Longmont | Longmont | Colorado |
United States | Jewish Hospital | Louisville | Kentucky |
United States | Saints Mary and Elizabeth Hospital | Louisville | Kentucky |
United States | UofL Health Medical Center Northeast | Louisville | Kentucky |
United States | Illinois CancerCare-Macomb | Macomb | Illinois |
United States | McFarland Clinic - Marshalltown | Marshalltown | Iowa |
United States | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois |
United States | Idaho Urologic Institute-Meridian | Meridian | Idaho |
United States | Community Medical Center | Missoula | Montana |
United States | Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho |
United States | Ochsner Medical Center Jefferson | New Orleans | Louisiana |
United States | Cancer Care Center of O'Fallon | O'Fallon | Illinois |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska |
United States | Alegent Health Immanuel Medical Center | Omaha | Nebraska |
United States | Alegent Health Lakeside Hospital | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Hematology and Oncology Consultants PC | Omaha | Nebraska |
United States | Memorial GYN Plus | Ooltewah | Tennessee |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Midlands Community Hospital | Papillion | Nebraska |
United States | Parker Adventist Hospital | Parker | Colorado |
United States | Rocky Mountain Cancer Centers-Parker | Parker | Colorado |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | OSF Saint Francis Radiation Oncology at Pekin | Pekin | Illinois |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Valley Radiation Oncology | Peru | Illinois |
United States | Mayo Clinic Hospital in Arizona | Phoenix | Arizona |
United States | University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania |
United States | Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho |
United States | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Rocky Mountain Cancer Centers - Pueblo | Pueblo | Colorado |
United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
United States | Radiation Oncology Associates | Reno | Nevada |
United States | Renown Regional Medical Center | Reno | Nevada |
United States | Saint Mary's Regional Medical Center | Reno | Nevada |
United States | Valley Medical Center | Renton | Washington |
United States | UT Southwestern Clinical Center at Richardson/Plano | Richardson | Texas |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri |
United States | Kootenai Clinic Cancer Services - Sandpoint | Sandpoint | Idaho |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
United States | FHCC South Lake Union | Seattle | Washington |
United States | Fred Hutchinson Cancer Center | Seattle | Washington |
United States | University of Washington Medical Center - Montlake | Seattle | Washington |
United States | Henry Ford Macomb Health Center - Shelby Township | Shelby | Michigan |
United States | Jewish Hospital Medical Center South | Shepherdsville | Kentucky |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Saint Michael Cancer Center | Silverdale | Washington |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Springfield Clinic | Springfield | Illinois |
United States | MD Anderson in Sugar Land | Sugar Land | Texas |
United States | Missouri Baptist Sullivan Hospital | Sullivan | Missouri |
United States | BJC Outpatient Center at Sunset Hills | Sunset Hills | Missouri |
United States | Southwest Illinois Health Services LLP | Swansea | Illinois |
United States | Franciscan Research Center-Northwest Medical Plaza | Tacoma | Washington |
United States | Northwest Medical Specialties PLLC | Tacoma | Washington |
United States | Rocky Mountain Cancer Centers-Thornton | Thornton | Colorado |
United States | Carle Cancer Center | Urbana | Illinois |
United States | The Carle Foundation Hospital | Urbana | Illinois |
United States | Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan |
United States | Mercy Medical Center-West Lakes | West Des Moines | Iowa |
United States | Ascension Via Christi Hospitals Wichita | Wichita | Kansas |
United States | Cancer Center of Kansas - Wichita | Wichita | Kansas |
United States | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas |
United States | Rush-Copley Healthcare Center | Yorkville | Illinois |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy. | The number of participants who received at least two cycles of the triplet neoadjuvant therapy getting at least one dose of maintenance therapy. | Duration of treatment until first dose of maintenance therapy. Includes 21 day cycles of neoadjuvant chemo and surgery - extrapleural pneumonectomy or pleurectomy/decortication (radiation therapy for participants who received extrapleural pneumonectomy). | |
Primary | Safety of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy. | The number of participants that experienced a Grade 4-5 immune-related adverse event. The regimen was considered safe if no participants experienced a Grade 4-5 immune-related AE. | Duration of treatment and follow-up until death or 3 years post Step 1 registration. | |
Secondary | Progression Free Survival (PFS) | From date of registration to Step 1 to date of first documentation of progression by RECIST 1.1 and modified RECIST 1.1, symptomatic deterioration, or death due to any cause. Participants last known to be alive and progression free are censored at date of last disease assessment. | Duration of treatment and follow-up until death or 3 years post Step 1 registration. | |
Secondary | Overall Survival (OS) | From date of initial registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact. | 3 years after the last accrual | |
Secondary | Response Rate (RR) | Percentage of participants with confirmed and unconfirmed, complete and partial, defined by RECIST 1.1 and mRECIST for Pleural Tumors | Duration of treatment and follow-up until death or 3 years post Step 1 registration. |
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