Carcinoma, Squamous Cell, Non-small-cell Lung Clinical Trial
Official title:
A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
| Verified date | April 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
| Status | Active, not recruiting |
| Enrollment | 591 |
| Est. completion date | March 12, 2025 |
| Est. primary completion date | September 21, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC. 2. Have Stage IV squamous NSCLC. 3. Have measurable disease based on RECIST 1.1. 4. Have not received prior systemic treatment for their advanced/metastatic NSCLC. 5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time. 6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention 7. Have a life expectancy of at least 3 months. 8. Has adequate organ function. 9. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards. 10. Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards. Exclusion Criteria: 1. Has non-squamous histology NSCLC. 2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment. 3. Has known active central nervous system metastases and/or carcinomatous meningitis. 4. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib. 5. Has a severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients. 6. Has an active autoimmune disease that has required systemic treatment in past 2 years. 7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. 8. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection. 9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment. 10. Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor. 11. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137). 12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Italiano Regional del Sur ( Site 0509) | Bahia Blanca | Buenos Aires |
| Argentina | Hospital Britanico de Buenos Aires ( Site 0500) | Buenos Aires | Caba |
| Argentina | Hospital Italiano de Buenos Aires ( Site 0511) | Buenos Aires | |
| Argentina | Clínica Universitaria Reina Fabiola ( Site 0505) | Cordoba | |
| Argentina | Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516) | Mar del Plata | Buenos Aires |
| Argentina | Instituto Medico Rio Cuarto ( Site 0501) | Rio Cuarto | Cordoba |
| Argentina | Centro Oncológico de Rosario ( Site 0507) | Rosario | Santa Fe |
| Argentina | Sanatorio Parque ( Site 0515) | Rosario | Santa Fe |
| Argentina | Centro Medico San Roque ( Site 0506) | San Miguel de Tucuman | Tucuman |
| Argentina | Sanatorio Privado San Geronimo S.R.L ( Site 0510) | Santa Fe | |
| Australia | Monash Cancer Centre ( Site 1205) | Clayton | Victoria |
| Australia | Liverpool Hospital ( Site 1201) | Liverpool | New South Wales |
| Australia | Townsville General Hospital ( Site 1202) | Townsville | Queensland |
| Australia | Southern Medical Day Care Centre ( Site 1200) | Wollongong | New South Wales |
| Austria | Innsbruck LKH ( Site 1302) | Innsbruck | Tirol |
| Austria | Ordensklinikum Linz GmbH Elisabethinen ( Site 1307) | Linz | Oberosterreich |
| Austria | Social Medical Center - Otto Wagner Hospital ( Site 1301) | Vienna | Wien |
| Austria | Klinikum Wels-Grieskirchen ( Site 1304) | Wels | Oberosterreich |
| Austria | Krankenhaus Nord - Klinik Floridsdorf ( Site 1300) | Wien | |
| Brazil | Oncologica do Brasil ( Site 0256) | Belem | Para |
| Brazil | Hospital Tacchini ( Site 0265) | Bento Goncalves | Rio Grande Do Sul |
| Brazil | Instituto do Cancer do Ceara ( Site 0251) | Fortaleza | Ceara |
| Brazil | Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252) | Itajai | Santa Catarina |
| Brazil | Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253) | Rio de Janeiro | |
| Brazil | Hospital Sao Rafael ( Site 0258) | Salvador - BA | Bahia |
| Brazil | Hospital de Base de Sao Jose de Rio Preto ( Site 0254) | Sao Jose Rio Preto | Sao Paulo |
| Brazil | Hospital Paulistano - Amil Clinical Research ( Site 0263) | Sao Paulo | |
| Brazil | Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250) | Sao Paulo | |
| Brazil | Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260) | Sao Paulo | |
| Canada | CISSS de la Monteregie-Centre ( Site 0101) | Greenfield Park | Quebec |
| Canada | Nova Scotia Health Authority ( Site 0103) | Halifax | Nova Scotia |
| Canada | Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107) | Hamilton | Ontario |
| Canada | Kingston Health Sciences Centre ( Site 0102) | Kingston | Ontario |
| Canada | Hopital Cite de la Sante de Laval ( Site 0105) | Laval | Quebec |
| Canada | CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110) | Montreal | Quebec |
| Canada | Stronach Regional Cancer Centre ( Site 0100) | Newmarket | Ontario |
| Canada | CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106) | Trois-Rivieres | Quebec |
| France | CHU Angers ( Site 1405) | Angers | Maine-et-Loire |
| France | CHU Caen ( Site 1406) | Caen | Calvados |
| France | Centre Hospitalier De Chauny ( Site 1411) | Chauny | Aisne |
| France | Centre Jean Perrin ( Site 1407) | Clermont Ferrand | Puy-de-Dome |
| France | Centre Hospitalier de Pau ( Site 1412) | Pau | Pyrenees-Atlantiques |
| France | CHU de Rouen ( Site 1403) | Rouen | Seine-Maritime |
| France | Hopital d'Instruction des Armees Begin ( Site 1413) | Saint-Mande | Val-de-Marne |
| France | Institut De Cancerologie De Lorraine ( Site 1409) | Vandoeuvre les Nancy | Meurthe-et-Moselle |
| France | Hopital Robert Schuman ( Site 1402) | Vantoux | Moselle |
| Germany | Studienzentrum Aschaffenburg ( Site 1575) | Aschaffenburg | Bayern |
| Germany | Universitaetsklinikum Bonn ( Site 1574) | Bonn | Nordrhein-Westfalen |
| Germany | Helios Klinikum Erfurt GmbH ( Site 1552) | Erfurt | Thuringen |
| Germany | Kliniken Essen Mitte ( Site 1567) | Essen | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Frankfurt ( Site 1563) | Frankfurt | Hessen |
| Germany | Universitaetsmedizin Goettingen ( Site 1557) | Goettingen | Niedersachsen |
| Germany | Katholisches Marienkrankenhaus gGmbH ( Site 1572) | Hamburg | |
| Germany | Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551) | Immenhausen | Hessen |
| Germany | InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564) | Koblenz | Rheinland-Pfalz |
| Germany | Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573) | Muenchen | Bayern |
| Germany | Klinikum der LMU ( Site 1550) | Munich | Bayern |
| Germany | Universitaetsklinikum Regensburg ( Site 1562) | Regensburg | Bayern |
| Germany | Klinikum Wuerzburg Mitte gGmbH ( Site 1559) | Wuerzburg | Bayern |
| Japan | National Hospital Organization Kyushu Medical Center ( Site 0805) | Fukuoka | |
| Japan | Kansai Medical University Hospital ( Site 0804) | Hirakata | Osaka |
| Japan | Kanazawa University Hospital ( Site 0811) | Kanazawa | Ishikawa |
| Japan | National Cancer Center Hospital East ( Site 0801) | Kashiwa | Chiba |
| Japan | Kurume University Hospital ( Site 0814) | Kurume | Fukuoka |
| Japan | Aichi Cancer Center Hospital ( Site 0803) | Nagoya | Aichi |
| Japan | National Hospital Organization Nagoya Medical Center ( Site 0806) | Nagoya | Aichi |
| Japan | Niigata Cancer Center Hospital ( Site 0808) | Niigata | |
| Japan | Okayama University Hospital ( Site 0810) | Okayama | |
| Japan | Osaka International Cancer Institute ( Site 0809) | Osaka | |
| Japan | National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813) | Sakai | Osaka |
| Japan | Sendai Kousei Hospital ( Site 0812) | Sendai | Miyagi |
| Japan | Shizuoka Cancer Center Hospital and Research Institute ( Site 0802) | Sunto-gun | Shizuoka |
| Japan | The Cancer Institute Hospital of JFCR ( Site 0800) | Tokyo | |
| Japan | Kanagawa Cancer Center ( Site 0807) | Yokohama | Kanagawa |
| Korea, Republic of | Chungbuk National University Hospital ( Site 1002) | Cheongju si | Chungbuk |
| Korea, Republic of | National Cancer Center ( Site 1006) | Goyang-si | Kyonggi-do |
| Korea, Republic of | The Catholic University of Korea St. Vincent s Hospital ( Site 1003) | Gyeonggi-do | Kyonggi-do |
| Korea, Republic of | Gyeongsang National University Hospital ( Site 1005) | Jinju | Kyongsangnam-do |
| Korea, Republic of | Korea University Guro Hospital ( Site 1008) | Seoul | |
| Korea, Republic of | Seoul National University Hospital ( Site 1000) | Seoul | |
| Korea, Republic of | Severance Hospital Yonsei University Health System ( Site 1001) | Seoul | |
| Korea, Republic of | Asan Medical Center ( Site 1007) | Songpa-gu | Seoul |
| Korea, Republic of | Ajou University Hospital ( Site 1004) | Suwon | Kyonggi-do |
| Mexico | Arke Estudios Clinicos ( Site 0333) | Cdmx | |
| Mexico | Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334) | Guadalajara | Jalisco |
| Mexico | Investigacion Onco Farmaceutica S de RL de CV ( Site 0300) | La Paz | Baja California Sur |
| Mexico | Axis Heilsa S. de R.L. de C.V. ( Site 0301) | Monterrey | Nuevo Leon |
| Mexico | CLIMERS Clinical Medical Research ( Site 0306) | Orizaba | Veracruz |
| Mexico | FAICIC Clinical Research ( Site 0303) | Veracruz | |
| New Zealand | MidCentral DHB Palmerston North Hospital ( Site 1102) | Palmerston North | Manawatu-Wanganui |
| New Zealand | Capital & Coast District Health Board - Wellington Hospital ( Site 1101) | Wellington | |
| Poland | Przychodnia Lekarska Komed ( Site 2416) | Konin | Wielkopolskie |
| Poland | Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420) | Krakow | Malopolskie |
| Poland | Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417) | Olsztyn | Dolnoslaskie |
| Poland | MED-POLONIA Sp. z o.o. ( Site 2419) | Poznan | Wielkopolskie |
| Poland | Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402) | Raciborz | Slaskie |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( | Warszawa | Mazowieckie |
| Poland | Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404) | Zgorzelec | Dolnoslaskie |
| Romania | S.C.Focus Lab Plus S.R.L ( Site 2502) | Bucuresti | |
| Romania | Cardiomed SRL Cluj-Napoca ( Site 2504) | Cluj Napoca | Cluj |
| Romania | S.C. Radiotherapy Center Cluj S.R.L ( Site 2507) | Cluj-Napoca | Cluj |
| Romania | Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei ( Site 2501) | Constanta | |
| Romania | S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508) | Craiova | Dolj |
| Romania | Policlinica Oncomed SRL ( Site 2505) | Timisoara | Timis |
| Russian Federation | Moscow Regional Oncological Dispensary ( Site 2028) | Balashikha | Moskovskaya Oblast |
| Russian Federation | Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021) | Kazan | Tatarstan, Respublika |
| Russian Federation | First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024) | Moscow | Moskva |
| Russian Federation | FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006) | Moscow | Moskva |
| Russian Federation | Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009) | Moscow | Moskva |
| Russian Federation | Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000) | Moscow | Moskva |
| Russian Federation | Nizhniy Novgorod Region Oncology Dispensary ( Site 2026) | Nizhniy Novgorod | Nizhegorodskaya Oblast |
| Russian Federation | Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site | Omsk | Omskaya Oblast |
| Russian Federation | National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SBHI Leningrad Regional Clinical Hospital ( Site 2002) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SPb Central Clinical Railway Hospital ( Site 2003) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SPb SBHI City Clinical Oncological Dispensary ( Site 2001) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016) | Samara | Samarskaya Oblast |
| Spain | Hospital Sant Creu i Sant Pau ( Site 1711) | Barcelona | |
| Spain | Hospital Duran i Reynals ( Site 1710) | Hospitalet de Llobregat | Barcelona |
| Spain | Complejo Hospitalario de Jaen ( Site 1713) | Jaen | La Coruna |
| Spain | Hospital Universitario 12 de Octubre ( Site 1716) | Madrid | |
| Spain | Complejo Hospitalario de Malaga ( Site 1714) | Malaga | |
| Spain | Hospital Universitario Virgen Macarena ( Site 1712) | Sevilla | |
| Taiwan | Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907) | Kaohsiung | |
| Taiwan | China Medical University Hospital ( Site 0904) | Taichung | |
| Taiwan | National Cheng Kung University Hospital ( Site 0905) | Tainan | |
| Taiwan | Mackay Memorial Hospital ( Site 0902) | Taipei | |
| Taiwan | National Taiwan University Hospital ( Site 0900) | Taipei | |
| Taiwan | Chang Gung Medical Foundation.Linkou Branch ( Site 0903) | Taoyuan | |
| Turkey | Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101) | Adana | |
| Turkey | Ankara Sehir Hastanesi ( Site 2105) | Ankara | |
| Turkey | Gazi Universitesi Tip Fakultesi ( Site 2104) | Ankara | |
| Turkey | Bezmialem Vakif Univ. Tip Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107) | Istanbul | |
| Turkey | Göztepe Prof. Dr. Süleyman Yalçin Sehir Hastanesi-oncology ( Site 2103) | Istanbul | |
| Turkey | Ege Universitesi Tip Fakultesi ( Site 2109) | Izmir | |
| Turkey | Erciyes Universitesi Tip Fakultesi ( Site 2108) | Kayseri | |
| Turkey | Ondokuz Mays Üniversitesi Tp Fakültesi Hastanesi-Oncology ( Site 2106) | Samsun | |
| Turkey | Namik Kemal Universitesi Tip Fakultesi ( Site 2100) | Tekirdag | Tekirdas |
| Ukraine | Cherkasy Regional Oncology Dispensary ( Site 2225) | Cherkasy | Cherkaska Oblast |
| Ukraine | City Clinical Hosp.4 of DCC ( Site 2215) | Dnipro | Dnipropetrovska Oblast |
| Ukraine | MI Precarpathian Clinical Oncology Center ( Site 2218) | Ivano-Frankivsk | Ivano-Frankivska Oblast |
| Ukraine | Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2226) | Kharkiv | Kharkivska Oblast |
| Ukraine | Regional Centre of Oncology-Thoracic organs ( Site 2219) | Kharkiv | Kharkivska Oblast |
| Ukraine | Medical Center Asklepion LLC ( Site 2243) | Khodosivka | Kyivska Oblast |
| Ukraine | PP PPC Acinus Medical and Diagnostic Centre ( Site 2223) | Kropyvnytskyi | Kirovohradska Oblast |
| Ukraine | Kyiv City Clinical Oncology Centre ( Site 2224) | Kyiv | Kyivska Oblast |
| Ukraine | Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227) | Kyiv | Kyivska Oblast |
| Ukraine | Medical Center Verum ( Site 2228) | Kyiv | |
| Ukraine | MI Odessa Regional Oncological Centre ( Site 2222) | Odesa | Odeska Oblast |
| Ukraine | Central City Clinical Hospital ( Site 2221) | Uzhgorod | Zakarpatska Oblast |
| United Kingdom | Birmingham Heartlands Hospital ( Site 1910) | Birmingham | |
| United Kingdom | West Suffolk Hospitals NHS Trust ( Site 1919) | Bury Saint Edmunds | Suffolk |
| United Kingdom | Colchester General Hospital ( Site 1911) | Colchester | Worcestershire |
| United Kingdom | Western General Hospital, Edinburgh ( Site 1924) | Edinburg | |
| United Kingdom | Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923) | London | London, City Of |
| United Kingdom | Chelsea and Westminster Hospital ( Site 1901) | London | London, City Of |
| United Kingdom | Newcastle Freeman Hospital ( Site 1902) | Newcastle-upon-Tyne | Newcastle Upon Tyne |
| United Kingdom | Singleton Hospital ( Site 1909) | Swansea | Wales |
| United Kingdom | Southend University Hospital NHS Foundation Trust ( Site 1913) | Westcliff-on-Sea | Essex |
| United States | MedStar Franklin Square Medical Center ( Site 0044) | Baltimore | Maryland |
| United States | Frontier Oncology ( Site 0052) | Billings | Montana |
| United States | Alabama Oncology Bruno Cancer Center ( Site 0001) | Birmingham | Alabama |
| United States | Boca Raton Regional Hospital ( Site 0018) | Boca Raton | Florida |
| United States | Bozeman Health Deaconness Cancer Center ( Site 0053) | Bozeman | Montana |
| United States | Disney Family Cancer Center ( Site 0005) | Burbank | California |
| United States | Waverly Hematology Oncology ( Site 0054) | Cary | North Carolina |
| United States | Mount Sinai Hospital Medical Center ( Site 0035) | Chicago | Illinois |
| United States | Columbus Regional Research Institute ( Site 0099) | Columbus | Georgia |
| United States | Barbara Ann Karmanos Cancer Institute ( Site 0046) | Detroit | Michigan |
| United States | Hattiesburg Clinic ( Site 0051) | Hattiesburg | Mississippi |
| United States | Thompson Cancer Survival Center ( Site 2812) | Knoxville | Tennessee |
| United States | Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039) | Merrillville | Indiana |
| United States | Mid-Florida Cancer Centers ( Site 0022) | Orange City | Florida |
| United States | Oncology of Northshore ( Site 0036) | Rolling Meadows | Illinois |
| United States | Cancer Care Northwest ( Site 0083) | Spokane Valley | Washington |
| United States | H. Lee Moffitt Cancer Center and Research Institute ( Site 0024) | Tampa | Florida |
| United States | Renovatio Clinical ( Site 0074) | The Woodlands | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Austria, Brazil, Canada, France, Germany, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Romania, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Progression-free Survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first. | Up to approximately 3 years | |
| Primary | Overall Survival (OS) | Overall survival is the time from the date of randomization to death due to any cause. | Up to approximately 4 years | |
| Secondary | Number of Participants With One or More Adverse Events (AEs) | An adverse event (AE) is defined as 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 5 years | |
| Secondary | Number of participants discontinuing study intervention due to adverse events (AEs) | An AE is defined as 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 5 years | |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health 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. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented. | Baseline (at randomization) and Week 18 post-randomization | |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score | The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" 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 lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented. | Baseline (at randomization) and Week 18 post-randomization | |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score | The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" 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 lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented. | Baseline (at randomization) and Week 18 post-randomization | |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. 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. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome. | Baseline (at randomization) and Week 18 post-randomization | |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. 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 quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. | Baseline (at randomization) and Week 18 post-randomization | |
| Secondary | Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health 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. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in Items 29 and 30 scale scores. | Up to approximately 5 years | |
| Secondary | Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score | The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" 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 lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in cough scale score. | Up to approximately 5 years | |
| Secondary | Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score | The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest pain?" 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 lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in chest pain scale score. | Up to approximately 5 years | |
| Secondary | Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. 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 lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in Item 8 scale score. | Up to approximately 5 years | |
| Secondary | Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. 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 quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in physical functioning Items 1 to 5 scale scores. | Up to approximately 5 years |