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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05226598
Other study ID # 7684A-007
Secondary ID MK-7684A-007KEYV
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 24, 2022
Est. completion date September 27, 2027

Study information

Verified date May 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 700
Est. completion date September 27, 2027
Est. primary completion date November 10, 2025
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: - A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC. - Has not received prior systemic treatment for metastatic NSCLC. - Has measurable disease based on RECIST 1.1, as determined by the local site assessment. - Has a life expectancy of at least 3 months. - Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method. Exclusion Criteria: - Known additional malignancy that is progressing or has required active treatment within the past 3 years. - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients. - 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 before the first dose of study medication. - Active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) - 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), Hepatitis B or/and Hepatitis C virus. - Received prior systemic anticancer therapy for metastatic disease. - Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. - History of allogeneic tissue/solid organ transplant. - Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). - Is unable or unwilling to take folic acid or vitamin B12 supplementation. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Pembrolizumab/Vibostolimab
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations
Drug:
Carboplatin
Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations
Cisplatin
Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations
Paclitaxel
Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations
Nab-paclitaxel
Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations
Pemetrexed
Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision
Biological:
Pembrolizumab
Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations

Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209) ABB Caba
Argentina Centro de Oncología e Investigación de Buenos Aires ( Site 0203) Berazategui Buenos Aires
Argentina Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202) Buenos Aires Caba
Argentina Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206) La Rioja
Argentina Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204) Mar del Plata Buenos Aires
Argentina Hospital Provincial del Centenario ( Site 0212) Rosario Santa Fe
Argentina Sanatorio Parque ( Site 0205) Rosario Santa Fe
Austria Medizinische Universität Graz ( Site 0704) Graz Steiermark
Austria Medizinische Universitaet Innsbruck ( Site 0703) Innsbruck Tirol
Austria Kepler Universitätsklinikum ( Site 0707) Linz Oberosterreich
Austria Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705) Linz Oberosterreich
Austria Klinik Penzing-2. Lungenabteilung ( Site 0702) Vienna Wien
Austria Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701) Wien
Brazil Clínica de Oncologia Reichow ( Site 0407) Blumenau Santa Catarina
Brazil Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403) Natal Rio Grande Do Norte
Brazil Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405) Porto Alegre Rio Grande Do Sul
Brazil Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406) Rio de Janeiro
Brazil Hospital Paulistano ( Site 0401) Sao Paulo
Chile Centro de Investigación Oncológica del Norte ( Site 0504) Antofagasta
Chile Biocenter ( Site 0514) Concepción Biobio
Chile Bradfordhill ( Site 0510) Santiago Region M. De Santiago
Chile Centro de Oncología de Precisión ( Site 0515) Santiago Region M. De Santiago
Chile FALP-UIDO ( Site 0505) Santiago Region M. De Santiago
Chile CIDO SpA-Oncology ( Site 0508) Temuco Araucania
Chile James Lind Centro de Investigación del Cáncer ( Site 0502) Temuco Araucania
Chile ONCOCENTRO APYS-ACEREY ( Site 0503) Viña del Mar Valparaiso
China Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602) Beijing Beijing
China Jilin Cancer Hospital-oncology department ( Site 2603) Changchun Jilin
China Hunan Cancer Hospital ( Site 2622) Changsha Hunan
China The Second Xiangya Hospital of Central South University ( Site 2623) Changsha Hunan
China Xiangya Hospital Central South University-Oncology department ( Site 2627) Changsha Hunan
China West China Hospital of Sichuan University ( Site 2610) Cheng Du Sichuan
China Sichuan Cancer hospital ( Site 2628) Chengdu Sichuan
China Fujian Provincial Cancer Hospital-oncology department ( Site 2621) Fuzhou Fujian
China Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Guangzhou Guangdong
China Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615) Hangzhou Zhejiang
China The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613) Hangzhou Zhejiang
China The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site Hangzhou Zhejiang
China Zhejiang Cancer Hospital-Oncology ( Site 2612) Hangzhou Zhejiang
China Harbin Medical University Cancer Hospital-oncology of department ( Site 2604) Harbin Heilongjiang
China Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619) Hefei Anhui
China Shandong Cancer Hospital-Oncology Department ( Site 2630) Jinan Shandong
China The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625) Nanchang Jiangxi
China The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624) Nanchang Jiangxi
China Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Nanjing Jiangsu
China Fudan University Shanghai Cancer Center ( Site 2616) Shanghai Shanghai
China Shanghai Pulmonary Hospital-Oncology Department ( Site 2601) Shanghai Shanghai
China Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606) Tianjin Tianjin
China Tongji Hospital Tongji Medical,Science & Technology ( Site 2617) Wuhan Hubei
China Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618) Wuhan Hubei
China The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607) Xi'an Shaanxi
China The First Affiliated hospital of Xiamen University ( Site 2626) Xiamen City Fujian
China The Second People's Hospital of Yibin ( Site 2629) Yibin Sichuan
China Henan Cancer Hospital ( Site 2608) Zhengzhou Henan
Colombia Administradora Country S.A. - Clinica del Country ( Site 0601) Bogotá Distrito Capital De Bogota
Colombia Fundación Colombiana de Cancerología Clínica Vida ( Site 0603) Medellin Antioquia
Colombia Oncomedica S.A.-Oncomedica S.A ( Site 0609) Montería Cordoba
Colombia Oncologos del Occidente ( Site 0608) Pereira Risaralda
Colombia Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606) Valledupar Cesar
France Institut de Cancérologie de l'Ouest ( Site 0802) ANGERS cedex 02 Maine-et-Loire
France Centre Hospitalier d'Avignon ( Site 0810) Avignon Vaucluse
France Centre Hospitalier d'Annecy ( Site 0807) Epagny Metz-Tessy Haute-Savoie
France Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th Lille Nord-Pas-de-Calais
France CENTRE LEON BERARD ( Site 0803) Lyon CEDEX 08 Rhone
France CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806) Orléans Centre
France HIA Sainte Anne ( Site 0804) Toulon Var
Germany Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913 Berlin
Germany GEFOS Gesellschaft f. onkologische Studien ( Site 0909) Dortmund Nordrhein-Westfalen
Germany SRH Wald-Klinikum Gera ( Site 0911) Gera Thuringen
Germany UKGM Gießen/Marburg-Medical Clinic V ( Site 0912) Gießen Hessen
Germany Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902) Lübeck Schleswig-Holstein
Israel Rambam Health Care Campus-Oncology ( Site 1303) Haifa
Israel Shaare Zedek Medical Center-Oncology ( Site 1306) Jerusalem
Israel Meir Medical Center-oncology ( Site 1301) Kfar Saba
Israel Sheba Medical Center-ONCOLOGY ( Site 1302) Ramat Gan
Israel Sourasky Medical Center-Oncology ( Site 1305) Tel Aviv
Japan Hyogo Cancer Center-Thoracic Oncology ( Site 2409) Akashi Hyogo
Japan National Hospital Organization Kyushu Cancer Center ( Site 2412) Fukuoka
Japan National Hospital Organization Kyushu Medical Center ( Site 2413) Fukuoka
Japan Kansai Medical University Hospital ( Site 2415) Hirakata Osaka
Japan Saitama Prefectural Cancer Center ( Site 2406) Ina-machi Saitama
Japan Kanazawa University Hospital ( Site 2407) Kanazawa Ishikawa
Japan Japanese Foundation for Cancer Research ( Site 2402) Koto Tokyo
Japan National Hospital Organization Shikoku Cancer Center ( Site 2414) Matsuyama Ehime
Japan Shizuoka Cancer Center ( Site 2408) Nagaizumi Shizuoka
Japan Miyagi Cancer Center ( Site 2401) Natori Miyagi
Japan Okayama University Hospital ( Site 2410) Okayama
Japan Showa University Hospital ( Site 2403) Shinagawa Tokyo
Japan Nippon Medical School Hospital ( Site 2404) Tokyo
Japan Ehime University Hospital ( Site 2411) Toon Ehime
Japan Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405) Yokohama Kanagawa
Korea, Republic of Pusan National University Hospital ( Site 2205) Busan Pusan-Kwangyokshi
Korea, Republic of Chungnam national university hospital-Department of Internal Medicine ( Site 2203) Daejeon Taejon-Kwangyokshi
Korea, Republic of Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202) Deagu Taegu-Kwangyokshi
Korea, Republic of Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201) Hwasun Jeonranamdo
Korea, Republic of Korea University Guro Hospital-Internal Medicine ( Site 2204) Seoul
Korea, Republic of Asan Medical Center ( Site 2206) Songpa-gu Seoul
Mexico Alivia Clínica de Alta Especialidad ( Site 0310) Ciudad de Mexico Distrito Federal
Mexico Hospital Civil Fray Antonio Alcalde ( Site 0307) Guadalajara Jalisco
Mexico Arké SMO S.A. de C.V. ( Site 0301) Mexico Distrito Federal
Mexico CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304) Saltillo Coahuila
Poland Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903) Bydgoszcz Kujawsko-pomorskie
Poland Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907) Bystra Slaskie
Poland Przychodnia Lekarska KOMED ( Site 1902) Konin Wielkopolskie
Poland Med-Polonia Sp. z o. o. ( Site 1909) Poznan Wielkopolskie
Poland Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906) Prabuty Pomorskie
Poland Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904) Przemysl Podkarpackie
Poland Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908) Warsaw Mazowieckie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier Warszawa Mazowieckie
Spain CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106) A Coruña La Coruna
Spain Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101) Barcelona
Spain Hospital Insular de Gran Canaria-Oncology ( Site 1102) Las Palmas de Gran Canaria Las Palmas
Spain Hospital Clinico San Carlos-Oncology Department ( Site 1107) Madrid
Spain Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103) Sevilla
Spain Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105) Zaragoza
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254) Kaohsiung
Taiwan China Medical University Hospital ( Site 2253) Taichung
Taiwan NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252) Tainan
Taiwan National Taiwan University Hospital-Oncology ( Site 2255) Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch ( Site 2251) Taoyuan
Thailand Faculty of Medicine Siriraj Hospital ( Site 2304) Bangkok Krung Thep Maha Nakhon
Thailand Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301) Chiang Mai
Thailand Songklanagarind hospital ( Site 2302) Hatyai Songkhla
Thailand Chulabhorn Hospital ( Site 2305) Lak Si Krung Thep Maha Nakhon
Thailand Faculty of Medicine - Khon Kaen University ( Site 2303) Muang Khon Kaen
Turkey Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208) Adana
Turkey Ankara City Hospital ( Site 1204) Ankara
Turkey Hacettepe Universitesi-oncology hospital ( Site 1202) Ankara
Turkey Liv Hospital Ankara-Oncology ( Site 1205) Ankara
Turkey Trakya University-Medical Oncology ( Site 1203) Edirne
Turkey TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209) Istanbul
Turkey Umraniye Training and Research Hospital-medical oncology ( Site 1206) Istanbul
Turkey Acibadem Altunizade Hospital-Oncology ( Site 1207) Üsküdar / Stanbul Istanbul
United Kingdom Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502) Leicester England
United Kingdom Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501) London England
United Kingdom St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506) London London, City Of
United Kingdom University College London Hospital-Cancer Clinical Trials Unit ( Site 1509) London-Camden London, City Of
United States Charleston Oncology ( Site 0019) Charleston South Carolina
United States University of Virginia Cancer Center ( Site 0018) Charlottesville Virginia
United States Mount Sinai Hospital ( Site 0011) Chicago Illinois
United States University of Chicago Medical Center ( Site 0015) Chicago Illinois
United States UCHealth Memorial Hospital-Heme Onc ( Site 0003) Colorado Springs Colorado
United States University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031) Fort Collins Colorado
United States Cancer and Hematology Centers of Western Michigan ( Site 0002) Grand Rapids Michigan
United States Mayo Clinic in Florida ( Site 0022) Jacksonville Florida
United States Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012) Lancaster Pennsylvania
United States Mayo Clinic in Rochester, Minnesota ( Site 0030) Rochester Minnesota
United States New England Cancer Specialists ( Site 0008) Scarborough Maine
United States Stony Brook University-Cancer Center ( Site 0013) Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  Chile,  China,  Colombia,  France,  Germany,  Israel,  Japan,  Korea, Republic of,  Mexico,  Poland,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) OS is defined as the time from randomization to the date of death due to any cause. Up to approximately 36 months
Secondary Progression-Free Survival (PFS) PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (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. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented. Up to approximately 27 months
Secondary Objective Response Rate (ORR) ORR is defined as the percentage of participants with 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 RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented. Up to approximately 27 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) Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. 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 quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. Baseline and Up to approximately 36 months
Secondary Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Baseline and Up to approximately 36 months
Secondary Change from Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Baseline and up to approximately 36 months
Secondary Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. Baseline and Up to approximately 36 months
Secondary Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. Baseline and Up to approximately 36 months
Secondary Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13 Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. Baseline and Up to approximately 36 months
Secondary Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30 TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. 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 quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. Up to approximately 36 months
Secondary TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30 TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. Up to approximately 36 months
Secondary TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. Up to approximately 36 months
Secondary TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. Up to approximately 36 months
Secondary TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. Up to approximately 36 months
Secondary TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. Up to approximately 36 months
Secondary Number of Participants Who Experienced One or More Adverse Events (AEs) The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. Up to approximately 36 months
Secondary Number of Participants Who Discontinued Study Intervention Due to an AE The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. Up to approximately 36 months
Secondary Duration of Response (DOR) For participants who demonstrate a 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 (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented. Up to approximately 27 months
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