Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05298423
Other study ID # 7684A-006
Secondary ID MK-7684A-006KEYV
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 3, 2022
Est. completion date September 4, 2029

Study information

Verified date June 2024
Source Merck Sharp & Dohme LLC
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
pembrolizumab/vibostolimab
Administered as an intravenous (IV) infusion
durvalumab
Administered as an IV infusion
Drug:
cisplatin
Administered as an IV infusion
pemetrexed
Administered as an IV infusion
etoposide
Administered as an IV infusion
carboplatin
Administered as an IV infusion
paclitaxel
Administered as an IV infusion
Radiation:
thoracic radiotherapy
Administered as an external beam radiation

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

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, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT04879849 - A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers Phase 1
Completed NCT04426825 - A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer Phase 2
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT02810457 - Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer Phase 3
Completed NCT02864394 - Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033) Phase 3
Recruiting NCT04592523 - A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
Recruiting NCT04838548 - A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer Phase 2
Recruiting NCT04077463 - A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer Phase 1
Recruiting NCT05167604 - Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
Recruiting NCT04603807 - A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases Phase 3
Completed NCT04948411 - Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
Active, not recruiting NCT04487080 - A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Phase 3
Not yet recruiting NCT04255836 - Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC) Phase 2
Completed NCT01953913 - Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation Phase 3
Recruiting NCT05715229 - Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy Phase 2
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Suspended NCT05421936 - Osimertinib for NSCLC With Uncommon EGFR Mutations
Completed NCT02847377 - A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC N/A
Completed NCT04427072 - Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation Phase 3
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A