Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)

Small Cell Lung Carcinoma Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05224141
• Other study ID #: 7684A-008
• Secondary ID: MK-7684A-008KEYV
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 24, 2022
• Est. completion date: June 7, 2027

Study information

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

Clinical Trial Summary

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: June 7, 2027
• Est. primary completion date: May 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy

• Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan

• Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse

• Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse

• Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

• Has a predicted life expectancy of >3 months

Exclusion Criteria:

• Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease

• Has received prior treatment for Small Cell Lung Cancer (SCLC)

• Is expected to require any other form of antineoplastic therapy for SCLC while on study

• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication

• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

• Has a history of severe hypersensitivity reaction (=Grade 3) to any study intervention and/or any of its excipients

• 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 a known history of, or active, neurologic paraneoplastic syndrome

• Has an active infection requiring systemic therapy

• Has a known history of human immunodeficiency virus (HIV) infection

• Has a known history of Hepatitis B or known active Hepatitis C virus infection

• Has had an allogenic tissue/solid organ transplant

• Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention

• Has symptomatic ascites or pleural effusion

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma

Intervention

Biological:
• Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Drug:
• Saline placebo
Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)
• Etoposide
Etoposide 100 mg/m^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles
• Cisplatin
Cisplatin 75 mg/m^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Biological:
• Atezolizumab
Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Drug:
• Carboplatin
Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)	ABB	Caba
Argentina	Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)	Buenos Aires	Caba
Argentina	Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)	Mar del Plata	Buenos Aires
Argentina	Hospital Provincial del Centenario ( Site 0205)	Rosario	Santa Fe
Argentina	Sanatorio Parque ( Site 0202)	Rosario	Santa Fe
Australia	Frankston Hospital-Oncology and Haematology ( Site 2702)	Frankston	Victoria
Australia	Nepean Hospital ( Site 2700)	Penrith	New South Wales
Australia	Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)	St Albans	Victoria
Australia	Calvary Mater Newcastle ( Site 2703)	Waratah	New South Wales
Austria	Medizinische Universität Graz ( Site 0504)	Graz	Steiermark
Austria	Kepler Universitätsklinikum ( Site 0507)	Linz	Oberosterreich
Austria	Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)	Linz	Oberosterreich
Austria	Klinik Penzing-2. Lungenabteilung ( Site 0502)	Vienna	Wien
Austria	Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501)	Wien
Canada	Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)	Kingston	Ontario
Canada	Lakeridge Health ( Site 0102)	Oshawa	Ontario
China	Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)	Beijing	Beijing
China	Beijing Peking Union Medical College Hospital ( Site 2921)	Beijing	Beijing
China	Jilin Cancer Hospital-GCP office ( Site 2909)	Changchun	Jilin
China	The First Hospital of Jilin University ( Site 2914)	Changchun	Jilin
China	Hunan Cancer Hospital ( Site 2907)	Changsha	Hunan
China	Sichuan Cancer hospital ( Site 2923)	Chengdu	Sichuan
China	West China Hospital Sichuan University ( Site 2903)	Chengdu	Sichuan
China	Fujian Provincial Cancer Hospital-oncology department ( Site 2904)	Fuzhou	Fujian
China	Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital-Oncology ( Site 2919)	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)	Harbin	Heilongjiang
China	Anhui Cancer Hospital ( Site 2915)	Hefei	Anhui
China	Fudan University Shanghai Cancer Center ( Site 2908)	Shanghai	Shanghai
China	Shanghai Chest Hospital-Oncology department ( Site 2900)	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University ( Site 2913)	Suzhou	Jiangsu
China	Hubei Cancer Hospital ( Site 2922)	Wuhan	Hubei
China	Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912)	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)	Xi'an	Shaanxi
China	Henan Cancer Hospital ( Site 2916)	Zhengzhou	Henan
Finland	Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)	Oulu	Pohjois-Pohjanmaa
Finland	Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)	Turku	Varsinais-Suomi
Finland	Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)	Vaasa	Pohjanmaa
France	Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané	Limoges	Haute-Vienne
France	Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)	Marseille	Bouches-du-Rhone
France	CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)	Toulouse	Haute-Garonne
Germany	SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)	Gera	Thuringen
Germany	LungenClinic Grosshansdorf-Onkologie ( Site 0903)	Grosshansdorf	Schleswig-Holstein
Germany	Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)	Hannover	Niedersachsen
Germany	Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)	Heidelberg	Baden-Wurttemberg
Germany	Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)	Immenhausen	Hessen
Greece	Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)	Athens	Attiki
Greece	Metropolitan Hospital ( Site 1001)	Athens	Attiki
Greece	Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)	Athens	Attiki
Greece	University General Hospital of Heraklion ( Site 1004)	Heraklion	Irakleio
Greece	European Interbalkan Medical Center ( Site 1000)	Thessaloniki
Hungary	Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)	Gyor	Gyor-Moson-Sopron
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)	Kaposvár	Somogy
Hungary	Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)	Kecskemét	Bacs-Kiskun
Hungary	Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)	Törökbálint	Pest
Ireland	Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)	Dublin
Ireland	St. James's Hospital ( Site 1200)	Dublin
Israel	Rambam Health Care Campus-Oncology ( Site 1301)	Haifa
Israel	Shaare Zedek Medical Center-Oncology ( Site 1300)	Jerusalem
Israel	Sheba Medical Center-ONCOLOGY ( Site 1302)	Ramat Gan
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)	Milan	Lombardia
Italy	Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)	Naples	Campania
Italy	Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)	Rome	Roma
Italy	Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)	Rozzano	Milano
Japan	National Hospital Organization Kyushu Medical Center ( Site 3013)	Fukuoka
Japan	Kansai Medical University Hospital ( Site 3009)	Hirakata	Osaka
Japan	Kanazawa University Hospital ( Site 3006)	Kanazawa	Ishikawa
Japan	National Cancer Center Hospital East ( Site 3002)	Kashiwa	Chiba
Japan	Japanese Foundation for Cancer Research ( Site 3003)	Koto	Tokyo
Japan	Kurume University Hospital ( Site 3014)	Kurume	Fukuoka
Japan	National Hospital Organization Shikoku Cancer Center ( Site 3012)	Matsuyama	Ehime
Japan	Shizuoka Cancer Center ( Site 3007)	Nagaizumi	Shizuoka
Japan	Aichi Cancer Center Hospital ( Site 3016)	Nagoya	Aichi
Japan	Niigata Cancer Center Hospital ( Site 3005)	Niigata-shi	Niigata
Japan	Okayama University Hospital ( Site 3011)	Okayama
Japan	National Hospital Organization Hokkaido Cancer Center ( Site 3015)	Sapporo	Hokkaido
Japan	Sendai Kousei Hospital ( Site 3001)	Sendai	Miyagi
Japan	Kanagawa cancer center-Department of Thoracic Oncology ( Site 3004)	Yokohama	Kanagawa
Korea, Republic of	Chungnam national university hospital-Department of Internal Medicine ( Site 2802)	Daejeon	Taejon-Kwangyokshi
Korea, Republic of	Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)	Deagu	Taegu-Kwangyokshi
Korea, Republic of	Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)	Hwasun	Jeonranamdo
Korea, Republic of	Korea University Guro Hospital-Internal Medicine ( Site 2803)	Seoul
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)	Kaunas
Lithuania	Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)	Klaipeda	Klaipedos Miestas
Lithuania	National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)	Vilnius	Vilniaus Miestas
Mexico	Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)	Guadalajara	Jalisco
Mexico	Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)	Guadalajara	Jalisco
Mexico	Arké SMO S.A. de C.V. ( Site 0401)	Mexico	Distrito Federal
Mexico	iCan Oncology Center Centro Medico AVE ( Site 0406)	Monterrey	Nuevo Leon
Mexico	Centro de Investigacion Clinica de Oaxaca ( Site 0410)	Oaxaca
Netherlands	Ziekenhuis Rijnstate ( Site 1606)	Arnhem	Gelderland
Netherlands	Jeroen Bosch Hospital-Pulmonology ( Site 1605)	Den Bosch	Noord-Brabant
Netherlands	Martini Ziekenhuis ( Site 1618)	Groningen
Netherlands	Medische Centrum Leeuwarden ( Site 1619)	Leeuwarden	Fryslan
Netherlands	Maastricht UMC+-Pulmonary disease ( Site 1602)	Maastricht	Limburg
Netherlands	Erasmus Medisch Centrum ( Site 1621)	Rotterdam	Zuid-Holland
Netherlands	Isala, locatie Zwolle-Poli Longziekten ( Site 1612)	Zwolle	Overijssel
Poland	Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)	Bystra	Slaskie
Poland	Przychodnia Lekarska KOMED ( Site 1701)	Konin	Wielkopolskie
Poland	Med-Polonia Sp. z o. o. ( Site 1710)	Poznan	Wielkopolskie
Poland	Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)	Prabuty	Pomorskie
Poland	Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)	Przemysl	Podkarpackie
Poland	Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)	Siedlce	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier	Warszawa	Mazowieckie
Portugal	Champalimaud Foundation ( Site 1812)	Lisbon	Lisboa
Portugal	Hospital CUF Descobertas ( Site 1815)	Lisbon	Lisboa
Portugal	Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813)	Porto
Portugal	Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810)	Porto
Romania	Centrul medical Focus ( Site 1903)	Bucure?ti	Bucuresti
Romania	MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905)	Bucure?ti	Bucuresti
Romania	Cardiomed SRL Cluj-Napoca ( Site 1900)	Cluj-Napoca	Cluj
Romania	Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 1901)	Craiova	Dolj
Romania	Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)	Craiova	Dolj
Romania	Cabinet Medical Oncomed ( Site 1902)	Timi?oara	Timis
Spain	Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)	Barcelona
Spain	Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)	Madrid	Madrid, Comunidad De
Spain	H.R.U Málaga - Hospital General-Oncology ( Site 2104)	Málaga	Malaga
Spain	Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)	Sevilla
Turkey	Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)	Adana
Turkey	Ankara Bilkent City Hospital ( Site 2403)	Ankara
Turkey	Hacettepe Universitesi-oncology hospital ( Site 2409)	Ankara
Turkey	Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)	Ankara
Turkey	Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)	Bornova	Izmir
Turkey	Medipol University Medical Faculty-oncology ( Site 2400)	Istanbul
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)	Istanbul
Turkey	I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)	Izmir, Karsiyaka	Izmir
United Kingdom	Heartlands Hospital-Oncology Research ( Site 2604)	Birmingham
United Kingdom	The Christie-Clinical Research Facility ( Site 2607)	Manchester	England
United Kingdom	Mount Vernon Hospital ( Site 2602)	Northwood	Hillingdon
United States	Blue Ridge Cancer Care ( Site 0015)	Blacksburg	Virginia
United States	Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)	Boca Raton	Florida
United States	Dana-Farber Cancer Institute ( Site 0018)	Boston	Massachusetts
United States	University of Virginia Cancer Center ( Site 0019)	Charlottesville	Virginia
United States	Fort Wayne Medical Oncology and Hematology ( Site 0013)	Fort Wayne	Indiana
United States	Cancer and Hematology Centers of Western Michigan ( Site 0001)	Grand Rapids	Michigan
United States	Hattiesburg Clinic Hematology/Oncology ( Site 0003)	Hattiesburg	Mississippi
United States	Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)	Lancaster	Pennsylvania
United States	Los Angeles Hematology Oncology Medical Group ( Site 0006)	Los Angeles	California
United States	VA West Los Angeles Medical Center ( Site 0004)	Los Angeles	California
United States	Infirmary Cancer Care ( Site 0022)	Mobile	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Canada,  China,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall Survival (OS) is the time from randomization to the date of death due to any cause.	Up to approximately 37 months
Secondary	Progression-Free Survival (PFS)	Progression-Free Survival (PFS) is the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first.	Up to approximately 26 months
Secondary	Objective Response Rate (ORR)	Objective Response Rate (ORR) is the percentage of participants who have a Complete Response (CR) (disappearance of all target lesions) or a Partial Response (PR) (at least a 30% decrease in the sum of diameters of target lesions).	Up to approximately 37 months
Secondary	Duration of Response (DOR)	Duration of Response (DOR) is the time from first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), until progressive disease (PD) or death.	Up to approximately 37 months
Secondary	Percentage of Participants Who Experienced an Adverse Event (AE)	An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to approximately 60 months
Secondary	Percentage of Participants Who Discontinued Study Treatment Due to an AE	An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to approximately 60 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)	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). A higher score indicates a better overall outcome.	Baseline and up to approximately 37 months
Secondary	Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30	The EORTC QLQ-C30 is a cancer specific health-related 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 37 months
Secondary	Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30	The EORTC QLQ-C30 is a cancer specific health-related 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 37 months
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)	The EORTC QLQ-LC13 is a lung cancer specific health-related 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 37 months
Secondary	Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13	EORTC QLQ-LC13 is a lung cancer specific health-related 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 37 months
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	The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the 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). 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.	Baseline and up to approximately 37 months
Secondary	TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30	The EORTC QLQ-C30 is a cancer specific health-related 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.	Baseline and up to approximately 37 months
Secondary	TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30	The EORTC QLQ-C30 is a cancer specific health-related 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.	Baseline and up to approximately 37 months
Secondary	TTD in Cough Score (Item 31) on the EORTC QLQ-LC13	The EORTC QLQ-LC13 is a lung cancer specific health-related 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.	Baseline and up to approximately 37 months
Secondary	TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13	The EORTC QLQ-LC13 is a lung cancer specific health-related 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.	Baseline and up to approximately 37 months

External Links

•   Merck Oncology Clinical Trials Information
•   Plain Language Summary