Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer Clinical Trial

— EVOKE-01  

Official title:

Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05089734
• Other study ID #: GS-US-577-6153
• Secondary ID: 2021-003578-30jR
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 17, 2021
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 603
• Est. completion date: March 2025
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).

• Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are required. Testing prior to enrollment. Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For patients with squamous cell carcinoma, EGFR and ALK testing is optional.

• Must have progressed after platinum-based chemotherapy in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially.

• No additional treatments are allowed in the recurrent/metastatic setting for individuals with no actionable genomic alterations.

• Individuals with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 locally approved and available tyrosine kinase inhibitor 1(TKI) appropriate to the genomic alteration.

• Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.

• Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in accordance with per RECIST Version 1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before randomization.

• Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin = 9 g/dL, absolute neutrophil count = 1500/mm^3, and platelets = 100,000/µL).

• Adequate hepatic function (bilirubin = 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase = 2.5 ULN or = 5 x ULN if known liver metastases, and serum albumin > 3 g/dL).

• Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation.

• Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

Key Exclusion Criteria:

• Mixed small-cell lung cancer and NSCLC histology.

• Positive serum pregnancy test or women who are lactating.

• Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, > Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.

• Have not recovered (ie, > Grade 2 is considered not recovered) from AEs due to a previously administered agent.

• Previously received treatment with any of the following:

• Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase 1

• Trop-2-targeted therapy

• Docetaxel as monotherapy or in combination with other agents

• Active second malignancy

• NSCLC that is eligible for definitive local therapy alone.

• Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy.

• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Active cardiac disease

• Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.

• Active serious infection requiring antibiotics.

• Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism.

• Positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease.

• Positive hepatitis C antibody and detectable hepatitis C viral load.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

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

Intervention

Biological:
• Sacituzumab Govitecan-hziy (SG)
Administered intravenously

Drug:
• Docetaxel
Administered intravenously

Locations

Country	Name	City	State
Australia	Border Medical Oncology Research Unit	Albury	New South Wales
Australia	Flinders Medical centre	Bedford Park	South Australia
Australia	Sunshine Coast University Private Hospital	Birtinya	Queensland
Australia	Southern Highlands Cancer Centre	Bowral	New South Wales
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Monash Health	Clayton	Victoria
Australia	St Vincent's Public Hospital	Darlinghurst	New South Wales
Australia	Peninsula & South Eastern Haematology and Oncology Group	Frankston	Victoria
Australia	Gallipoli Medical Research Foundation	Greenslopes	Queensland
Australia	Icon Cancer Centre	Hobart	Tasmania
Australia	Joondalup Health Campus	Joondalup	Western Australia
Australia	ir Charles Gairdner Hospital	Perth	Western Australia
Austria	Medizinische Universität Innsbruck, Medizinische Universitat Innsbruck, Universitatsklinik fur Innere Medizin V, Hamatologie und Onkolgie	Innsbruck
Austria	Muellner Hauptstrabe 48	Salzburg
Austria	zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU	Salzburg
Austria	Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie	Vienna
Belgium	Algemeen Ziekenhuis Klina	Brasschaat
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Algemeen Ziekenhuis Sint-Lucas	Gent
Belgium	Az Maria Middelares Ghent	Gent
Belgium	CHU Ambroise Pare	Mons
Brazil	CRIO - Centro Regional Integrado de Oncologia	Fortaleza
Brazil	ONCOSITE - Centro de Pesquisa Clinica em Oncologia	Ijui
Brazil	Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral	Itajai
Brazil	Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho	Jau
Brazil	Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa	Porto Alegre
Brazil	Hospital de Clínicas de Porto Alegre - HCPA	Porto Alegre
Brazil	Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP	Sao Paolo
Brazil	Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC	Sao Paulo
Brazil	A Beneficência Portuguesa de São Paulo	São Paulo
Canada	Royal Victoria Regional Health Centre	Barrie
Canada	William Osler Health System-Brampton Civic Hospital	Brampton
Canada	McGill University Health Centre	Montreal
Canada	Required Centre Hospitalier Regional de Rimouski	Rimouski
Canada	Windsor Regional Hospital Cancer Program	Windsor
France	Institut Sainte Catherine	Avignon
France	Centre Hospitalier de la Côte Basque	Bayonne
France	APHP-Hopital Ambroise-Pare	Boulogne-Billancourt
France	CHU de CAEN	Caen
France	Centre Francois Baclesse	Calvados
France	Centre Hospitalier de Chauny	Chauny
France	CHU-Hopital Gabriel Montpied	Clermont Ferrand
France	Centre Hospitalier Intercommunal de Creteil	Creteil
France	Centre Hospitalier Annecy Genevois	Epagny Metz-tessy
France	Centre Hospitalier Departemental Vendee	La Roche-sur-Yon
France	Clinique Victor Hugo	Le Mans
France	CHU de Lille	Lille
France	Hopital Dupuytren (CHU de Limoges)	Limoges cedex
France	Chu Montpellier Hopital Arnaud de Villeneuve	Montpellier
France	GHR Sud Alsace - Hopital Emile Muller	Mulhouse
France	Institut Curie	Paris cedex 05
France	CHU de Bordeaux Hopital Haut leveque	Pessac
France	Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud	Pierre Benite
France	CHU de Poitiers	Poitiers
France	Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle	Rouen
France	Hopital Foch	Saint Herblain
France	Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN)	saint Herblain
France	Institut Cancérologie Strasbourg Europe	Strasbourg
France	CHITS-Hopital Sainte Musse	Toulon cedex
Germany	Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie	Braunschweig
Germany	Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie	Esslingen
Germany	Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung	Hamburg
Germany	Studiengeselischaft Hamato-Onkologie Hamburg	Hamburg
Germany	Onkologische Schwerpunktpraxis Heilbronn	Heilbronn
Germany	Lungenfachklink Immenhausen	Immenhausen
Germany	Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie	Kassel
Germany	Universitatsklinikum Schleswig-Holstein - Campus Lubeck, Medizinische Klinik III (Studienzentrum Pneumologie)	Lubeck
Germany	University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology	Mannheim
Germany	Asklepios-Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirurgie	Munchen-Gauting
Germany	Sana Klinikum Offenbach, Medizinische Klinik IV fur Hamatologie und internistische Onkologie	Offenbach
Greece	General Hospital of Chest Diseases "I Sotiria", 3rd Internal Medicine Department of Athens University - Oncology Unit	Athens
Greece	Henry Dunant Hospital Center, 4th Oncology Department	Athens
Greece	Metropolitan General, Oncology department	Cholargos
Greece	General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology	Heraklion
Greece	University General Hospital of Larissa, Oncology Department-1St Internal Medical Division	Larisa
Greece	General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology	Nea Kifisia
Greece	Euromedica General Clinic of Thessaloniki	Thessaloniki
Greece	Interbalkan Medical Center of Thessaloniki	Thessaloniki
Israel	Samson Assuta Ashdod University Hospital	Ashdod
Israel	Soroka Medical Center	Beer Seva
Israel	Hadassah University Hospital Ein Kerem	Jerusalem
Israel	Kaplan Medical Center	Rehovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Shamir Medical Center (Assaf Harofeh)	Tzrifin
Italy	ASST Papa Giovanni XXIII, Oncologia Medica	Bergamo
Italy	Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia	Brescia
Italy	AOU Policlinico G Rodlico-Oncologia Medica	Catania
Italy	AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale	Catanzaro
Italy	ASST Cremona	Cremona
Italy	ASST Grande Ospedale Metropolitano Niguarda SC Oncologia	Milano
Italy	Instituto Europeo di Oncologia	Milano
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica	Roma
Italy	UOC Oncologia	San Giovanni Rotondo
Italy	ASST Bergamo Ovest- ospedale di Treviglio-u.o. Oncologia	Treviglio
Italy	SC Oncologia -ASST SETTE LAGHI	Varese
Japan	National Hospital Organization Asahikawa Medical Center	Asahikawa
Japan	National Cancer Center Hospital	Chuo
Japan	Fukui Prefectural Hospital	Fukui
Japan	Kansai Medical University Hospital	Hirakata
Japan	Hiroshima University Hospital	Hiroshima
Japan	Kobe City Medical Center General Hospital	Hyogo
Japan	National Hospital Organization Himeji Medical Center	Hyogo
Japan	Nippon Medical School Chiba Hokusoh Hospital	Inzai
Japan	National Hospital Organization Iwakuni Clinical Center	Iwakuni
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center	Kanagawaken
Japan	Kanazawa University Hospital	Kanazawa
Japan	National Cancer Center Hospital East	Kashiwa
Japan	Saitama Cancer Center	Kitaadachi-gun
Japan	The Cancer Institute Hospital of JFCR	Koto
Japan	Kurume University Hospital	Kurume
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto
Japan	Shikoku Cancer Center	Matsuyama
Japan	Miyagi Cancer Center	Miyagi
Japan	Nagasaki University Hospital	Nagasaki
Japan	National Hospital Organization Nagoya Medical Center	Nagoya
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Okayama University Hospital	Okayama
Japan	Osaka Prefectural Hospital Organization Osaka International Cancer Institute	Osaka
Japan	Kindai University Hospital	Osakasayama-Shi
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center	Sakai
Japan	Centor Hospital of the National Center for Global Health and Medicine	Shinjuku-Ku
Japan	Shizuoka Cancer Center	Sunto-gun
Japan	National Hospital Organization Osaka Toneyama Medical Center	Toyonaka
Japan	Tochigi Cancer Center	Utsunomiya
Japan	Japanese Red Cross Wakayama Medical Center	Wakayama
Japan	Kanagawa Cancer Center	Yokohama
Japan	Yokohama Municipal Citizen's Hospital	Yokohama
Japan	Tottori University Hospital	Yonago
Mexico	Cryptex Investigación Clínica, S.A. de C.V.	Ciudad de Mexico
Mexico	Actualidad Basada en la Investigación del Cáncer	Guadalajara
Mexico	Panamerican Clinical Research S.A. de C.V	Guadalajara
Netherlands	Amphia Hospital	Breda
Netherlands	Haaglanden Medical Centre	Den Haag
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Erasmus MC	Rotterrdam
Netherlands	Elisabeth-TweeSteden Ziekenhuis (ETZ)	Tilburg
Poland	Przychodnia Lekarska Komed Roman Karaszewski	Konin
Poland	Instytut MSF Sp. z o.o.	Lodz
Poland	Centrum Medyczne Mrukmed	Rzeszáw
Poland	Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii	Siedlce
Portugal	Instituto Português de Oncologia de Coimbra Francisco Gentil	Coimbra
Portugal	Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente	Lisboa
Portugal	Fundacao Champalimaud	Lisbon
Portugal	Senhora da Hora	Matosinhos
Portugal	Centro Hospitalar Universitario do Porto	Porto
Portugal	Hospital CUF Porto	Porto
Portugal	Instituto Portugues de Oncologia do Porto	Porto
Puerto Rico	Ad-Vance Medical Research, LLC	Ponce
Puerto Rico	Pan American Center For Oncology Trials, LLC	San Juan
Spain	Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera	A coruna
Spain	Institut Catala d'Oncologia Badalona, ICO Badalona, Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Universitario Cruces	Barakaldo
Spain	Hospital Universitari Dexeus	Barcelona
Spain	Hospital Universitario Vall D'Hebron	Barcelona
Spain	Institut Catala D'Oncologia (ICO L'Hospitalet) Hospital Duran i Reynals	Barcelona
Spain	Hospital San Pedro de Alcantara	Cáceres
Spain	Institut Catala d'Oncologia de Girona	Girona
Spain	Hospital Clinical San Carlos	Madrid
Spain	Hospital Universitario 12 Octubre	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario Fundacion Jimenez Dias	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital universitario la paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Regional Universitario de Malaga-Hospital Civil	Malaga
Spain	Hospital Clinicl universitario virgen de la Arrixaca	Murcia
Spain	Clinica Universidad de Navarra-Pamplona	Pamplona
Spain	Hospital de Sabadell	Sabadell
Spain	Hospital universitario Virgen Macarena	Sevilla
Spain	Hospital Virgen de Valme	Sevilla
Spain	Hospital Universitario la Fe	Valencia
Turkey	Hacettepe Üniversitesi Hastanesi	Ankara
Turkey	Memorial Ankara Hastane	Ankara
Turkey	Acibadem Bursa Hastanesi	Bursa
Turkey	Ankara Sehir Hastanesi	Dikimevi- Ankara
Turkey	Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi	Edirne
Turkey	Bagcilar Medipol Mega Universite Hastanesi	Istanbul
Turkey	T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi	Kadikoy
Turkey	Acibadem Maslak Hastanesi	Sariyer
Turkey	Gazi Universitesi Gazi Hastanesi	Yenimahalle
United Kingdom	University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital	Birmingham
United Kingdom	East Suffolk and North Essex NHS Foundation Trust	Colchester
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	St James University Hospital	Leeds
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Barts Health NHS Trust	London
United Kingdom	The Christie NHS Foundation	Manchester
United States	Alaska Oncology and Hematology, LLC.	Anchorage	Alaska
United States	Rocky Mountain Cancer Centers - Aurora	Aurora	Colorado
United States	Texas Oncology - Bedford	Bedford	Texas
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Tennessee Oncology, PLLC	Chattanooga	Tennessee
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Maryland Oncology Hematology, P.A.	Clinton	Maryland
United States	Zangmeister Cancer Center	Columbus	Ohio
United States	Texas Oncology - Denison	Denison	Texas
United States	Texas Oncology - Denton South	Denton	Texas
United States	Florida Cancer Specialists (Administration and Drug Shipment)	Fort Myers	Florida
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Broome Oncology, LLC	Johnson City	New York
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Nebraska Hematology - Oncology	Lincoln	Nebraska
United States	University of Wisconsin Clinical Science Center	Madison	Wisconsin
United States	Texas Oncology Cancer Care and Research Center	McAllen	Texas
United States	USOR - Texas Oncology - McKinney	McKinney	Texas
United States	Baptist Clinical Research Institute	Memphis	Tennessee
United States	Froedtert Hospital/Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Texas Oncology - Paris	Paris	Texas
United States	Woodlands Medical Specialists, PA	Pensacola	Florida
United States	FirstHealth Outpatient Cancer Center	Pinehurst	North Carolina
United States	Texas Oncology-Plano East	Plano	Texas
United States	Texas Oncology-Plano West	Plano	Texas
United States	Park Nicollet Frauenshuh Cancer Center	Saint Paul	Minnesota
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	W.G (Bill) Hefner VAMC	Salisbury	North Carolina
United States	Siouxland Regional Cancer Center dba June E. Nylen Cancer Center	Sioux City	Iowa
United States	Stony Brook Cancer Center	Stony Brook	New York
United States	USOR - Arizona Oncology Associates Tucson - Wilmot	Tucson	Arizona
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	Kansas City VA Medical Center	Westwood	Kansas
United States	Shenandoah Oncology Associates, PC	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Mexico,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS is defined as the time from the date of randomization until the date of death from any cause.	Up to 30 months
Secondary	Progression-free Survival (PFS) Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	PFS is defined as the time from the date of randomization until the date of objective disease progression (PD) or death from any cause, whichever occurs first.	Up to 30 months
Secondary	Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.	Up to 30 months
Secondary	Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1	DOR is defined as time from first documented CR or PR to the earlier of the first documented PD or death from any cause (whichever comes first)	Up to 30 months
Secondary	Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1	DCR is defined as the proportion of participants who achieve a CR, PR, or stable disease (SD) as assessed by RECIST Version 1.1.	Up to 30 months
Secondary	Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)		First dose date up to 30 months plus 30 days
Secondary	Percentage of Participants Experiencing Laboratory abnormalities		First dose date up to 30 months plus 30 days
Secondary	Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Score	The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No	Up to 30 Months
Secondary	Time to First Deterioration in NSCLC-SAQ Total Score	The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No	Up to 30 Months

External Links

•   Gilead Clinical Trials Website