Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC
This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: - progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. - overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.
Status | Recruiting |
Enrollment | 784 |
Est. completion date | September 4, 2029 |
Est. primary completion date | September 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria - Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC. - Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8 - Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon - Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain - Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review - Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC - Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional]) - Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention - Has a life expectancy of at least 6 months Exclusion Criteria - Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible - Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer - Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention - Is expected to require any other form of antineoplastic therapy, while on study - Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention - Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication - Has a known additional malignancy that is progressing or has required active treatment within the past 5 years - Has an active autoimmune disease that has required systemic treatment in past 2 years - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has an active infection requiring systemic therapy - Has a known history of human immunodeficiency virus (HIV) infection - Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection - Has had an allogenic tissue/solid organ transplant Pemetrexed-specific Criteria: - Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed - Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone |
Country | Name | City | State |
---|---|---|---|
Australia | Ballarat Health Services-Medical Oncology ( Site 0002) | Ballarat Central | Victoria |
Australia | Canberra Hospital ( Site 0010) | Canberra | Australian Capital Territory |
Australia | Frankston Hospital-Oncology and Haematology ( Site 0009) | Frankston | Victoria |
Australia | Icon Cancer Centre Hobart ( Site 0003) | Hobart | Tasmania |
Australia | St Vincent's Hospital-Oncology Clinical Trials ( Site 0005) | Melbourne | Victoria |
Brazil | Hospital Nossa Senhora da Conceição ( Site 0111) | Porto Alegre | Rio Grande Do Sul |
Brazil | Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0105) | Rio de Janeiro | |
Brazil | A. C. Camargo Cancer Center-CAPEC ( Site 0102) | Sao Paulo | |
Chile | Biocenter ( Site 0208) | Concepción | Biobio |
Chile | Bradfordhill ( Site 0200) | Santiago | Region M. De Santiago |
Chile | Centro de Oncología de Precisión ( Site 0209) | Santiago | Region M. De Santiago |
Chile | FALP-UIDO ( Site 0205) | Santiago | Region M. De Santiago |
Chile | James Lind Centro de Investigación del Cáncer ( Site 0202) | Temuco | Araucania |
Chile | ONCOCENTRO APYS-ACEREY ( Site 0203) | Viña del Mar | Valparaiso |
China | Beijing Cancer hospital-intrathoratic deparmtment II ( Site 0328) | Beijing | Beijing |
China | Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 0309) | Beijing | Beijing |
China | Beijing Peking Union Medical College Hospital-pneumology department ( Site 0300) | Beijing | Beijing |
China | Jilin Cancer Hospital-oncology department ( Site 0319) | Changchun | Jilin |
China | Hunan Cancer Hospital ( Site 0307) | Changsha | Hunan |
China | Xiangya Hospital Central South University-Oncology department ( Site 0310) | Changsha | Hunan |
China | West China Hospital of Sichuan University ( Site 0324) | Cheng Du | Sichuan |
China | Army Medical Center of People's Liberation Army-Oncology Department ( Site 0321) | Chongqing | Chongqing |
China | Fujian Provincial Cancer Hospital ( Site 0316) | Fuzhou | Fujian |
China | Fujian Medical University Union Hospital-1 Bingfanglou ( Site 0330) | Fuzhou Fujian | Fujian |
China | Southern Medical University Nanfang Hospital-Department of Oncology ( Site 0336) | Guangzhou | Guangdong |
China | Hangzhou Cancer Hospital-Medical Oncology ( Site 0302) | Hangzhou | Zhejiang |
China | The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301) | Hangzhou | Zhejiang |
China | Zhejiang Cancer Hospital ( Site 0308) | Hangzhou | Zhejiang |
China | Shandong Provincial Hospital ( Site 0326) | Jinan | Shandong |
China | Qingdao Central Hospital-Endocrinology ( Site 0332) | Qingdao | Shandong |
China | Fudan University Shanghai Cancer Center ( Site 0304) | Shanghai | Shanghai |
China | Shanghai Chest Hospital-Radiotherapy Department ( Site 0306) | Shanghai | Shanghai |
China | Shanghai Pulmonary Hospital-Radiotherapy department ( Site 0335) | Shanghai | Shanghai |
China | Fourth Hospital of Hebei Medical University ( Site 0331) | Shijiazhuang | Hebei |
China | The Second Affiliated Hospital of Soochow University ( Site 0314) | Suzhou | Jiangsu |
China | Shanxi Cancer Hospital-Pulmonology ( Site 0322) | Taiyuan | Shanxi |
China | Tianjin Medical University Cancer Institute and Hospital-radiotherapy ( Site 0329) | Tianjin | Tianjin |
China | Hubei Cancer Hospital ( Site 0311) | Wuhan | Hubei |
China | Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0315) | Wuhan | Hubei |
China | The First Affiliated hospital of Xiamen University-oncology ( Site 0317) | Xiamen | Fujian |
China | Henan Cancer Hospital ( Site 0333) | Zhengzhou | Henan |
China | Affiliated Hospital of Jiangsu University ( Site 0305) | Zhenjiang | Jiangsu |
Costa Rica | CIMCA ( Site 0501) | San José | San Jose |
Costa Rica | PROCLINICAL Pharma ( Site 0504) | San José | San Jose |
Costa Rica | Hospital Metropolitano - Sede Lindora ( Site 0503) | Santa Ana | San Jose |
Dominican Republic | Onconet ( Site 3002) | Distrito Nacional | Santo Domingo |
Dominican Republic | Instituto de Oncologia ( Site 3003) | Santo Domingo | Distrito Nacional |
Germany | Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0603 | Berlin | |
Germany | Klinikum Chemnitz-Klinik für Innere Medizin IV ( Site 0607) | Chemnitz | Sachsen |
Germany | LungenClinic Grosshansdorf-Onkologie ( Site 0602) | Grosshansdorf | Schleswig-Holstein |
Germany | Universitaetsklinikum Schleswig-Holstein Campus Kiel-Medizinische Klinik II, Hämatologie und Onkolo | Kiel | Schleswig-Holstein |
Greece | Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0706) | Athens | Attiki |
Greece | Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 0703) | Athens | Attiki |
Greece | Metropolitan Hospital ( Site 0702) | Athens | Attiki |
Greece | Sotiria Thoracic Diseases Hospital of Athens ( Site 0704) | Athens | Attiki |
Greece | University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0700) | Heraklion | Irakleio |
Greece | General Oncology Hospital of Kifissia "Agioi Anargiroi"-2nd Department of Medical Oncology ( Site 07 | Nea Kifissia | Attiki |
Greece | European Interbalkan Medical Center ( Site 0701) | Thessaloniki | |
Guatemala | Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0802) | Ciudad de Guatemala | |
Guatemala | Centro Medico Integral De Cancerología (CEMIC) ( Site 0805) | Quetzaltenango | |
Guatemala | Centro Regional de Sub Especialidades Médicas SA ( Site 0801) | Quetzaltenango | |
Israel | Rambam Health Care Campus-Oncology ( Site 1001) | Haifa | |
Israel | Shaare Zedek Medical Center ( Site 1003) | Jerusalem | |
Israel | Rabin Medical Center ( Site 1004) | Petah Tikva | |
Israel | Sheba Medical Center-ONCOLOGY ( Site 1000) | Ramat Gan | |
Israel | Sourasky Medical Center ( Site 1002) | Tel Aviv | |
Italy | Azienda Ospedaliera Spedali Civili di Brescia ( Site 1105) | Brescia | |
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100) | Milan | Lombardia |
Italy | Ospedale San Raffaele ( Site 1104) | Milano | Lombardia |
Italy | Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1102) | Monza | Lombardia |
Italy | Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia medica Toraco-Polmonare ( Site 1107) | Napoli | Campania |
Italy | Fondazione IRCCS Policlinico San Matteo ( Site 1103) | Pavia | Lombardia |
Italy | Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 1101) | Roma | Lazio |
Japan | Kansai Medical University Hospital ( Site 1207) | Hirakata | Osaka |
Japan | Saitama Prefectural Cancer Center ( Site 1201) | Ina-machi | Saitama |
Japan | Kobe Minimally Invasive Cancer Center ( Site 1210) | Kobe | Hyogo |
Japan | Japanese Foundation for Cancer Research ( Site 1202) | Koto | Tokyo |
Japan | Kurume University Hospital ( Site 1212) | Kurume | Fukuoka |
Japan | National Hospital Organization Shikoku Cancer Center ( Site 1211) | Matsuyama | Ehime |
Japan | Miyagi Cancer Center ( Site 1200) | Natori | Miyagi |
Japan | Niigata Cancer Center Hospital ( Site 1205) | Niigata-shi | Niigata |
Japan | Osaka International Cancer Institute ( Site 1209) | Osaka | |
Japan | Sendai Kousei Hospital ( Site 1213) | Sendai | Miyagi |
Japan | Showa University Hospital ( Site 1203) | Shinagawa | Tokyo |
Japan | Osaka Medical and Pharmaceutical University Hospital ( Site 1208) | Takatsuki | Osaka |
Japan | Kanagawa cancer center ( Site 1204) | Yokohama | Kanagawa |
Korea, Republic of | Chungbuk National University Hospital-Internal medicine ( Site 2400) | Cheongju-si | Chungbuk |
Korea, Republic of | Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 2403) | Seoul | |
Korea, Republic of | Ajou University Hospital-Hematology-Oncology ( Site 2402) | Suwon-si | Kyonggi-do |
Korea, Republic of | The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2401) | Suwon-si | Kyonggi-do |
Malaysia | Hospital Pulau Pinang ( Site 1400) | George Town | Pulau Pinang |
Malaysia | Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1401) | Kuala Lumpur | |
Malaysia | University Malaya Medical Centre-Clinical Oncology ( Site 1402) | Lembah Pantai | Kuala Lumpur |
Mexico | Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 1507) | Chihuahua | |
Mexico | Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 1505) | Guadalajara | Jalisco |
Mexico | Arké SMO S.A. de C.V. ( Site 1504) | Mexico | Distrito Federal |
Mexico | Centro de Investigacion Clinica de Oaxaca ( Site 1501) | Oaxaca | |
Philippines | Veterans Memorial Medical Center-Section of Oncology ( Site 3201) | Quezon City | National Capital Region |
Portugal | Hospital CUF Descobertas ( Site 2006) | Lisbon | Lisboa |
Portugal | Centro Hospitalar do Porto - Hospital de Santo António ( Site 2004) | Porto | |
Portugal | Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2001) | Porto | |
Romania | Centrul Medical Medicover Victoria ( Site 2106) | Bucharest | Bucuresti |
Romania | Centrul de Oncologie "Sfântul Nectarie" ( Site 2100) | Craiova | Dolj |
Romania | Amethyst Radiotherapy Center ( Site 2102) | Flore?ti | Cluj |
Romania | Radiology Therapeutic Center ( Site 2108) | Otopeni | Ilfov |
Romania | Cabinet Medical Oncomed ( Site 2101) | Timi?oara | Timis |
South Africa | Cape Town Oncology Trials ( Site 2306) | Cape Town | Western Cape |
South Africa | The Oncology Centre ( Site 2300) | Durban | Kwazulu-Natal |
South Africa | CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2304) | Port Elizabeth | Eastern Cape |
South Africa | Wilgers Oncology Centre ( Site 2301) | Pretoria | Gauteng |
South Africa | Abraham Oncology ( Site 2303) | Richards Bay | Kwazulu-Natal |
Spain | HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit | Barcelona | Cataluna |
Spain | Hospital Universitari Vall d'Hebron ( Site 2501) | Barcelona | Cataluna |
Spain | HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504) | Pozuelo de Alarcon | Madrid, Comunidad De |
Spain | CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2502) | Santiago de Compostela | La Coruna |
Turkey | Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2607) | Adana | |
Turkey | Ankara City Hospital-Medical Oncology ( Site 2601) | Ankara | |
Turkey | Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 2602) | Ankara | |
Turkey | Hacettepe Universitesi-oncology hospital ( Site 2605) | Ankara | |
Turkey | Memorial Ankara Hastanesi-Medical Oncology ( Site 2609) | Ankara | |
Turkey | Ege University Medicine of Faculty-Chest Diseases Department ( Site 2603) | Bornova | Izmir |
Turkey | TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2610) | Istanbul | |
Turkey | I.E.U. Medical Point Hastanesi-Oncology ( Site 2612) | Izmir | |
Turkey | Medipol Mega Universite Hastanesi-oncology ( Site 2611) | Stanbul | Istanbul |
Ukraine | Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 2905) | Kropyvnytskyi | Kirovohradska Oblast |
Ukraine | Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" | Vinnytsia | Vinnytska Oblast |
United States | MFSMC-HJWCI ( Site 2804) | Baltimore | Maryland |
United States | Boston Medical Center ( Site 2829) | Boston | Massachusetts |
United States | University of Chicago Medical Center ( Site 2828) | Chicago | Illinois |
United States | Millennium Oncology Research Clinic ( Site 2801) | Hollywood | Florida |
United States | Millennium Research & Clinical Development ( Site 2811) | Houston | Texas |
United States | Franciscan St. Francis Health ( Site 2812) | Indianapolis | Indiana |
United States | Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 2827) | Lancaster | Pennsylvania |
United States | VA Long Beach Healthcare System ( Site 2831) | Long Beach | California |
United States | VA West Los Angeles Medical Center ( Site 2808) | Los Angeles | California |
United States | Rutgers Cancer Institute of New Jersey ( Site 2805) | New Brunswick | New Jersey |
United States | Icahn School of Medicine at Mount Sinai ( Site 2821) | New York | New York |
United States | Mid Florida Hematology and Oncology Center ( Site 2800) | Orange City | Florida |
United States | Thomas Jefferson University - Clinical Research Institute ( Site 2813) | Philadelphia | Pennsylvania |
United States | Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816) | Portland | Oregon |
United States | Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 2837) | Springfield | Missouri |
United States | MultiCare Health System ( Site 2817) | Tacoma | Washington |
United States | Central Texas Veterans health care-Oncology & Hematology ( Site 2819) | Temple | Texas |
United States | White Plains Hospital ( Site 2835) | White Plains | New York |
United States | University of Massachusetts Chan Medical School ( Site 2815) | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme LLC |
United States, Australia, Brazil, Chile, China, Costa Rica, Dominican Republic, Germany, Greece, Guatemala, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Philippines, Portugal, Romania, South Africa, Spain, Turkey, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival (PFS) For All Participants | PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =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 =5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR). | Up to approximately 55 months | |
Primary | Progression-Free Survival (PFS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1% | PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =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 =5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR). | Up to approximately 55 months | |
Primary | Overall Survival (OS) For All Participants | OS is defined as the time from randomization to death due to any cause. | Up to approximately 75 months | |
Primary | Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1% | OS is defined as the time from randomization to death due to any cause. | Up to approximately 75 months | |
Secondary | Objective Response Rate (ORR) For All Participants | ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR). | Up to approximately 75 months | |
Secondary | Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1% | ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR). | Up to approximately 75 months | |
Secondary | Number of Participants Who Experience at Least One Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to approximately 75 months | |
Secondary | Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to approximately 75 months | |
Secondary | Duration of Response (DOR) For All Participants | Duration of Response (DOR) is the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR). | Up to approximately 75 months | |
Secondary | Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1% | Duration of Response (DOR) is the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR). | Up to approximately 75 months | |
Secondary | Change from Baseline in the Global Health Status /Quality of Life Items 29 and 30 Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) For All Participants | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. | Baseline (at randomization) and at the end of study (approximately 75 months post randomization) | |
Secondary | Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1% | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. | Baseline (at randomization) and at the end of study (approximately 75 months post randomization) | |
Secondary | Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life. | Baseline (at randomization) and at the end of study (approximately 75 months post randomization) | |
Secondary | Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1% | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life. | Baseline (at randomization) and at the end of study (approximately 75 months post randomization) | |
Secondary | Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) For All Participants | The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. | Baseline (at randomization) and at the end of study (approximately 75 months post randomization) | |
Secondary | Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1% | The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. | Baseline (at randomization) and at the end of study (approximately 75 months post randomization) | |
Secondary | Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants | The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. | Baseline (at randomization) and at the end of study (approximately 75 months post randomization) | |
Secondary | Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1% | The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. | Baseline (at randomization) and at the end of study (approximately 75 months post randomization) | |
Secondary | Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants | The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. | Baseline (at randomization) and at the end of study (approximately 75 months post randomization) | |
Secondary | Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1% | The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. | Baseline (at randomization) and at the end of study (approximately 75 months post randomization) | |
Secondary | Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For All Participants | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline. | Up to approximately 75 months post randomization | |
Secondary | Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1% | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline. | Up to approximately 75 months post randomization | |
Secondary | Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline. | Up to approximately 75 months post randomization | |
Secondary | Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1% | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline. | Up to approximately 75 months post randomization | |
Secondary | Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants | The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline. | Up to approximately 75 months post randomization | |
Secondary | Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1% | The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline. | Up to approximately 75 months post randomization | |
Secondary | Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants | The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline. | Up to approximately 75 months post randomization | |
Secondary | Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1% | The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline. | Up to approximately 75 months post randomization | |
Secondary | Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants | The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline. | Up to approximately 75 months post randomization | |
Secondary | Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1% | The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline. | Up to approximately 75 months post randomization |
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