Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106546
• Other study ID #: M11-089
• Secondary ID: 2013-005020-42
• Status: Completed
• Phase: Phase 3
• Start date: April 10, 2014
• Est. completion date: November 20, 2019

Study information

• Verified date: October 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 970
• Est. completion date: November 20, 2019
• Est. primary completion date: January 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Life expectancy > 12 weeks

2. Subject must have cytologically or histologically confirmed squamous NSCLC.

3. Subject must have advanced or metastatic squamous NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening.

4. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.

5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a computerized tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors (RECIST - version 1.1).

Exclusion Criteria:

1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).

2. Subject has a known hypersensitivity to platinum compounds.

3. Subject has peripheral neuropathy >= grade 2.

4. Subject has non-squamous NSCLC, or a known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement.

5. Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Carboplatin
Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.
• Veliparib
Capsules taken orally twice a day, 12 hours apart.
• Paclitaxel
Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
• Placebo to veliparib
Capsules taken orally twice a day, 12 hours apart.

Locations

Country	Name	City	State
Australia	Flinders Centre for Innovation /ID# 125605	Bedford Park	South Australia
Australia	Sunshine Coast University Hosp /ID# 125608	Birtinya	Queensland
Australia	The Townsville Hospital /ID# 125609	Douglas	Queensland
Australia	Barwon Health University Hospital Geelong /ID# 125606	Geelong	Victoria
Australia	Southern Medical Day Care Ctr /ID# 125604	Wollongong	New South Wales
Australia	The Queen Elizabeth Hospital /ID# 125607	Woodville	South Australia
Austria	Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183	Linz
Belarus	Bobruysk Interdistrict Onco. /ID# 128999	Bobruisk
Belarus	Brest Regional Hospital /ID# 125955	Brest
Belarus	State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815	Lesnoy
Belarus	Mogilev Reg Clin Oncology Dis /ID# 128639	Mogilev
Belarus	Vitebsk Reg Clin Onc Disp /ID# 125516	Vitebsk
Brazil	Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736	Barretos	Sao Paulo
Brazil	Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738	Itajai	Santa Catarina
Brazil	Hospital Sao Lucas da PUCRS /ID# 127737	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto COI de Educacao e Pesquisa /ID# 127739	Rio de Janeiro
Brazil	Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309	Rio de Janeiro
Brazil	Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737	Sao Paulo
Canada	University of Calgary /Id# 126326	Calgary	Alberta
Canada	Cross Cancer Institute /ID# 126154	Edmonton	Alberta
Canada	Juravinski Cancer Clinic /ID# 126153	Hamilton	Ontario
Canada	Victoria Hospital /ID# 126669	London	Ontario
Canada	McGill Univ HC /ID# 130431	Montreal	Quebec
Canada	The Ottawa Hospital /ID# 126522	Ottawa	Ontario
Canada	Iucpq-Ul /Id# 126524	Québec	Quebec
Canada	CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149	Quebec City	Quebec
Canada	Princess Margaret Cancer Centre /ID# 126155	Toronto	Ontario
Croatia	Klinicki bolnicki centar Osijek /ID# 132214	Osijek	Osjecko-baranjska Zupanija
Croatia	Opca bolnica Pula /ID# 126540	Pula
Croatia	Opca bolnica Dr. Josip Bencevi /ID# 126539	Slavonski Brod
Croatia	Klinika za plucne bolesti Jordanovac /ID# 126537	Zagreb	Grad Zagreb
Czechia	Nemocnice Kyjov, prispevkova organizace /ID# 125819	Kyjov
Czechia	Nemocnice Na Plesi s.r.o. /ID# 125817	Nová Ves pod Pleší	Pribram
Czechia	Nemocnice Novy Jicin /ID# 125818	Nový Jicín 1
Czechia	Fakultni Nemocnice Olomouc /ID# 125820	Olomouc	Olomoucky Kraj
Czechia	Vitkovicka nemocnice a. s. /ID# 127023	Ostrava
Denmark	Herlev Hospital /ID# 125995	Herlev	Hovedstaden
Denmark	Odense Universitets Hospital /ID# 125996	Odense C	Syddanmark
Egypt	University of Alexandria /ID# 128337	Alexandria
Egypt	Cairo Uni Hosp Al Kasr El Ainy /ID# 128338	Cairo
Egypt	Cairo Uni Hosp Al Kasr El Ainy /ID# 128340	Cairo
Egypt	Naser Institute for Res & Dev /ID# 129263	Cairo
Estonia	North Estonian Medical Centre /ID# 128215	Tallinn
Estonia	Tartu University Hospital /ID# 127735	Tartu
Finland	Helsinki Univ Central Hospital /ID# 125897	Helsinki
Finland	Vaasa Central Hospital /ID# 125896	Vaasa
France	CHRU de Brest - Hopital Morvan /ID# 127903	Brest
France	Centre Hosp Intercommunal de Creteil /ID# 125922	Creteil	Val-de-Marne
France	Centre Hospitalier Le Mans /ID# 127902	Le Mans CEDEX 9	Sarthe
France	CHRU Lille - Hôpital Claude Huriez /ID# 126353	Lille CEDEX	Hauts-de-France
France	CHU Hopital Nord /ID# 128388	Marseille	Bouches-du-Rhone
France	Centre Antoine Lacassagne /ID# 126360	Nice
France	Hopital Haut-Lévêque /ID# 135270	Pessac CEDEX	Gironde
France	Hospital Pontchaillou /ID# 126356	Rennes
France	Hopital Larrey - CHU de Toulouse /ID# 128394	Toulouse
Germany	Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708	Berlin
Germany	Lungen Clinic Grosshansdorf /ID# 126107	Grosshansdorf
Germany	Klinikum Kassel /ID# 127025	Kassel
Germany	Klinik Loewenstein GmbH /ID# 126191	Löwenstein
Germany	Univ Johannes Gutenberg /ID# 125603	Mainz
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879	Athens
Greece	Metropolitan Hospital /ID# 125878	Athens
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 125877	Heraklion
Greece	Papageorgiou General Hospital Thessaloniki /ID# 125876	Nea Efkarpia	Thessaloniki
Hungary	Orszagos Koranyi Pulmonologiai Intezet /ID# 126112	Budapest XII	Budapest
Hungary	Debreceni Egyetem Klinikai Központ /ID# 126119	Debrecen
Hungary	Veszprem Megyei Tudogyogyintez /ID# 126121	Farkasgyepu
Hungary	Petz Aladar Megyei Oktato Korh /ID# 126110	Gyor
Hungary	Bekes Megyei Pandy Kalman Korhaz /ID# 126117	Gyula
Hungary	Matrahaza Gyogyintezet /ID# 126109	Kékesteto
Hungary	CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234	Miskolc	Borsod-Abauj-Zemplen
Hungary	Fejer Megyei Szent Gyorgy Korh /ID# 126118	Szekesfehervar
Hungary	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120	Szolnok
Hungary	Tudogyogyintezet Toeroekbalint /ID# 126111	Torokbalint
Ireland	Cork University Hospital /ID# 126176	Cork
Ireland	Beaumont Hospital /ID# 126218	Dublin
Ireland	St. James's Hospital /ID# 126177	Dublin 8	Dublin
Ireland	University Hospital Limerick /ID# 126175	Limerick
Ireland	University Hospital Waterford /ID# 126178	Waterford
Israel	Assaf Harofeh Medical Center /ID# 127076	Be'er Ya'akov
Israel	Hadassah University Hospital /ID# 127077	Jerusalem
Israel	Meir Medical Center /ID# 127078	Kfar Saba
Israel	Sheba Medical Center /ID# 127079	Ramat Gan
Italy	AO San Giuseppe Moscati /ID# 125701	Avellino
Italy	Istituto Europeo di Oncologia /ID# 125702	Milan
Italy	Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704	Monza
Italy	A.O.U. San Luigi Gonzaga /ID# 125700	Orbassano
Italy	Azienda Ospedaliero Uni Parma /ID# 125703	Parma
Italy	Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699	Perugia
Italy	Istituto Oncologico del Medite /ID# 132844	Viagrande
Latvia	P. Stradins Clinical Univ Hosp /ID# 126322	Riga
Latvia	Riga East Clinical Univ Hosp /ID# 125597	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176	Kovno	Kaunas
Lithuania	National Cancer Institute /ID# 126323	Vilnius
Mexico	Centro Estatal de Cancerologia /ID# 127583	Chihuahua
Mexico	Hospital Angeles Centro Medico /ID# 127620	San Luis Potosí
Mexico	Cancerologia de Queretaro S.C. /ID# 125920	Santiago de Querétaro
Netherlands	Vrije Universiteit Medisch Centrum /ID# 125578	Amsterdam
Netherlands	Amphia Ziekenhuis /ID# 126466	Breda
Netherlands	Catharina Ziekenhuis /ID# 125577	Eindhoven
Netherlands	Ziekenhuis St. Jansdal /ID# 125576	Harderwijk
Netherlands	Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710	Heerlen
Netherlands	Jeroen Bosch Ziekenhuis /ID# 125709	S Hertogenbosch
Netherlands	Isala /ID# 125579	Zwolle
New Zealand	Wellington Hospital (Capital and Coast District Health Board) /ID# 125755	Wellington
Norway	Haukeland University Hospital /ID# 126338	Bergen	Hordaland
Norway	Nordland Hospital /ID# 126337	Bodø
Norway	Sorlandet Sykehus HF /ID# 126341	Kristiansand
Norway	Oslo Universitetssykehus, Radiumhospitalet /ID# 126335	Oslo
Norway	Stavanger University Hospital /ID# 126336	Stavanger
Norway	Sykehuset i Vestfold HF /ID# 126340	Tonsberg
Poland	Szpital Morski im. PCK /ID# 126547	Gdynia
Poland	Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548	Rzeszów	Podkarpackie
Poland	NZOZ Magodent Ctr. Med. Ostro /ID# 126545	Warsaw
Poland	Mazowiecki Szpital Onkologiczn /ID# 126546	Wieliszew
Portugal	CCA Braga - Hospital de Braga /ID# 125837	Braga
Portugal	Ctr Hosp Univ Coimbra, EPE /ID# 125838	Coimbra
Portugal	Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761	Guimaraes	Braga
Portugal	Hospital Pulido Valente /ID# 125835	Lisbon
Portugal	Centro Hospitalar de Sao Joao, EPE /ID# 125875	Porto
Portugal	IPO Porto FG, EPE /ID# 125836	Porto
Puerto Rico	VA Caribbean Healthcare System /ID# 124562	San Juan
Russian Federation	Belgorod Oncology Dispensary /ID# 129899	Belgorod
Russian Federation	Sverdlovsk Regional Oncology Center Dispensary /ID# 128457	Ekaterinburg	Sverdlovskaya Oblast
Russian Federation	State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460	Irkutsk
Russian Federation	Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458	Moscow	Moskva
Russian Federation	State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461	Murmansk
Russian Federation	Orenburg Regional Clinical Onc /ID# 137474	Orenburg
Russian Federation	Ogarev Mordovia State Univ /ID# 127595	Saransk
Russian Federation	Smolensk Regional Onc Clin Dis /ID# 127144	Smolensk
Russian Federation	Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143	Tomsk
Russian Federation	Volgograd Regional Clinical Oncology Dispensary /ID# 126350	Volgograd	Volgogradskaya Oblast
Serbia	Clinical Center Serbia /ID# 128738	Belgrade	Beograd
Serbia	Institute for Oncology and Rad /ID# 128721	Belgrade
Serbia	University Hospital Bezanijska /ID# 128761	Belgrade
Serbia	Clinical Center of Nis /ID# 128735	NIS	Nisavski Okrug
Serbia	Institute For Pulmonary Diseas /ID# 128737	Sremska Kamenica
Slovakia	Univerzitna Nemocnica Bratislava /ID# 126342	Bratislava
Slovakia	MEDEON, s.r.o. /ID# 128517	Pieštany
South Africa	Netcare Oncology Intervent Ctr /ID# 126100	Cape Town	Western Cape
South Africa	The Oncology Centre /ID# 126096	Durban	Kwazulu-Natal
South Africa	Cancercare Outeniqua Oncology Unit /ID# 126103	George	Western Cape
South Africa	Sandton Oncology Centre /ID# 126097	Johannesburg	Gauteng
South Africa	Wits Clinical Research Site /ID# 126101	Johannesburg	Gauteng
South Africa	GVI Oncology /ID# 126102	Port Elizabeth	Eastern Cape
South Africa	Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098	Pretoria	Gauteng
South Africa	Mary Potter Oncology Centre /ID# 126099	Pretoria	Gauteng
South Africa	University of Pretoria /ID# 127297	Pretoria	Gauteng
Spain	Hospital Universitario Vall d'Hebron /ID# 125159	Barcelona
Spain	Hospital Duran i Reynals /ID# 125161	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario HM Sanchinarro /ID# 125162	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160	Majadahonda	Madrid
Spain	Hospital Universitario Virgen del Rocio /ID# 125207	Sevilla
Spain	Fundacion Instituto Valenciano Oncologia IVO /ID# 125205	Valencia
Sweden	Gavle Sjukhus /ID# 126444	Gavle
Sweden	Sahlgrenska University Hosp /ID# 129997	Goteborg
Sweden	University Hospital Linkoping /ID# 126443	Linkoping
Sweden	Karolinska Univ Sjukhuset /ID# 126445	Solna
Switzerland	Hirslanden Medical Center /ID# 128216	Aarau
Switzerland	Inselspital, Universitaetsklinik /ID# 126347	Bern
Switzerland	Kantonsspital St. Gallen /ID# 126349	St. Gallen	Sankt Gallen
Switzerland	Spital STS AG /ID# 126348	Thun
Turkey	Akdeniz University Medical Fac /ID# 126997	Antalya
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186	Istanbul
Turkey	Marmara University Medical Fac /ID# 126187	Istanbul
Turkey	Dr. Suat Seren Gogus Has /ID# 126190	Izmir
Turkey	Ege University Medical Faculty /ID# 126189	Izmir
Ukraine	Cherkassy Regional Onc Ctr /ID# 128222	Cherkasy
Ukraine	Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220	Chernivtsi
Ukraine	Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217	Dnipro
Ukraine	Communal non-profit enterprise Regional Center of Oncology /ID# 128221	Kharkiv	Kharkivska Oblast
Ukraine	Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218	Lviv
Ukraine	Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223	Poltava
Ukraine	Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219	Sumy
United Kingdom	Betsi Cadwaladr Univ Health Bo /ID# 127177	Bangor
United Kingdom	North Devon District Hospital /ID# 125689	Barnstaple
United Kingdom	The Royal Bournemouth Hospital /ID# 125690	Bournemouth
United Kingdom	East Kent Hosp Univ NHS Trust /ID# 125698	Canterbury
United Kingdom	Cheltenham General Hospital /ID# 125692	Cheltenham	Gloucestershire
United Kingdom	Gartnavel General Hospital /ID# 126233	Glasgow
United Kingdom	James Paget University Hosp /ID# 125696	Great Yarmouth
United Kingdom	Charing Cross Hospital /ID# 125688	London
United Kingdom	Guy's and St Thomas' NHS Found /ID# 125694	London	London, City Of
United Kingdom	Maidstone Hospital /ID# 125693	Maidstone
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228	Newcastle Upon Tyne
United Kingdom	Norfolk and Norwich Univ Hosp /ID# 125697	Norwich	Norfolk
United Kingdom	The Clatterbridge Cancer Ctr /ID# 125695	Wirral
United States	Illinois Cancer Specialists /ID# 127468	Arlington Heights	Illinois
United States	Winship Cancer Institute of Emory University /ID# 124061	Atlanta	Georgia
United States	VA Eastern Colorado Healthcare System /ID# 128065	Aurora	Colorado
United States	Texas Oncology - Austin Midtown /ID# 127477	Austin	Texas
United States	Texas Oncology - South Austin /ID# 127476	Austin	Texas
United States	St. Luke's Mountain States Tumor Institute - Boise /ID# 124059	Boise	Idaho
United States	University of Vermont Medical Center /ID# 128064	Burlington	Vermont
United States	Gabrail Cancer Center Research /ID# 127415	Canton	Ohio
United States	Parkland Health and Hosp Syste /ID# 128518	Dallas	Texas
United States	Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385	Dallas	Texas
United States	UT Southwestern Medical Center /ID# 127876	Dallas	Texas
United States	Henry Ford Health System /ID# 126500	Detroit	Michigan
United States	NorthShore University HealthSystem - Evanston Hospital /ID# 128585	Evanston	Illinois
United States	Holy Cross Hospital /ID# 128074	Fort Lauderdale	Florida
United States	University of Florida - Archer /ID# 126476	Gainesville	Florida
United States	The Jones Clinic, PC /ID# 124062	Germantown	Tennessee
United States	Goshen Center for Cancer Care /ID# 123875	Goshen	Indiana
United States	Hackensack Univ Med Ctr /ID# 124057	Hackensack	New Jersey
United States	Ingalls Memorial Hosp /ID# 128360	Harvey	Illinois
United States	Appalachian Regional Healthcare, Inc (ARH) /ID# 128061	Hazard	Kentucky
United States	Penn State University and Milton S. Hershey Medical Center /ID# 126676	Hershey	Pennsylvania
United States	University of Texas MD Anderson Cancer Center /ID# 127946	Houston	Texas
United States	Franciscan St. Francis Health /ID# 126678	Indianapolis	Indiana
United States	Cancer Specialists of North Florida - Southpoint /ID# 127815	Jacksonville	Florida
United States	Northeast Arkansas Clinical Ch /ID# 128071	Jonesboro	Arkansas
United States	Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156	Lansing	Michigan
United States	Comprehensive Cancer Ctrs Neva /ID# 127491	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center /ID# 128075	Lebanon	New Hampshire
United States	Nebraska Hematology Oncology /ID# 127699	Lincoln	Nebraska
United States	SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477	Lincoln	Nebraska
United States	LA Hem-Oncology Med Group /ID# 129178	Los Angeles	California
United States	Minnesota Oncology Hematology, PA /ID# 127473	Minneapolis	Minnesota
United States	Virginia Oncology Associates /ID# 127458	Norfolk	Virginia
United States	Texas Oncology - Paris /ID# 127484	Paris	Texas
United States	Northwest Cancer Specialists, P.C. /ID# 127486	Vancouver	Washington
United States	Northwest Cancer Specialists, P.C. /ID# 127488	Vancouver	Washington
United States	Texas Oncology - Waco /ID# 127459	Waco	Texas
United States	Midwestern Regional CTC /ID# 126124	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belarus,  Brazil,  Canada,  Croatia,  Czechia,  Denmark,  Egypt,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Latvia,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30).		From Screening (prior to dosing) up to 2 years
Other	Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Lung Cancer 13 Question Questionnaire (EORTC-LC13).		From Screening (prior to dosing) up to 2 years
Other	Change in Eastern Cooperative Oncology Group (ECOG) Performance Status		From Screening (prior to dosing) up to 2 years
Other	Change in Quality of Life: European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)		From Screening (prior to dosing) up to 2 years
Other	Duration of Response	The duration of overall response for a given subject will be defined as the number of days from the day the criteria are met for Complete or Partial Response (whichever is recorded first) to the date that Progressive Disease (PD) is objectively documented.	From complete or partial response to disease progression (up to 3 years from randomization).
Primary	Overall Survival (OS) in current smokers	Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.	Up to 3 years from first dose of study drug
Secondary	Overall Survival (OS) in all subjects	Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.	Up to 3 years from first dose of study drug
Secondary	Progressive-Free Survival (PFS) in current smokers and in all subjects	Defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached.	Up to 3 years from first dose of study drug
Secondary	Objective Response Rate (ORR) in current smokers and in all subjects	Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1)	Up to 3 years from first dose of study drug