A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)

Advanced Non-small Cell Lung Cancer Clinical Trial

— SOHO-02  

Official title:

A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452277
• Other study ID #: 22615
• Secondary ID: 2024-511319-91-0
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 24, 2024
• Est. completion date: May 15, 2028

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations.

Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division.

The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC.

The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations.

The study participants will receive one of the study treatments:

• BAY 2927088 twice every day as a tablet by mouth, or

• Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment.

During the study, the doctors and their study team will:

• take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer

• check the overall health of the participants by performing tests such as blood and urine tests, and checking

• heart health using an electrocardiogram (ECG)

• perform pregnancy tests for women

• ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 278
• Est. completion date: May 15, 2028
• Est. primary completion date: June 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant must be =18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.

• Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).

• Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.

• No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.

• Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.

Exclusion Criteria:

• Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:

• a. in situ cancers of cervix, breast, or skin,

• b. superficial bladder cancer (Ta, Tis and T1),

• c. limited-stage prostate cancer,

• d. basal or squamous cancers of the skin.

• Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.

• Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for >4 weeks prior to planned start of study intervention.

• Pre-existing peripheral neuropathy that is Grade =2 by CTCAE (v5.0).

• History of severe hypersensitivity reaction to treatment with a monoclonal antibody.

• Prior radiotherapy outside of the brain within 21 days of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Related Conditions & MeSH terms

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

Intervention

Drug:
• BAY2927088
Tablet, oral
• Pembrolizumab
Intravenous (IV) infusion
• Cisplatin
IV infusion
• Carboplatin
IV infusion
• Pemetrexed
IV infusion

Locations

Country	Name	City	State
Argentina	Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Fundación Cenit para la Investigación en Neurociencias	Caba	Ciudad Auton. De Buenos Aires
Argentina	Centro Médico Privado CEMAIC	Córdoba
Argentina	Instituto Argentino de Diagnostico y Tratamiento (IADT)	TBC
Argentina	Centro de Investigaciones Clínicas, Clínica Viedma	Viedma
Australia	The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC)	Garran
Australia	Blacktown Cancer & Haematology Centre	Liverpool	New South Wales
Australia	Calvary Mater Hospital Newcastle	Waratah	New South Wales
Austria	Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III	Salzburg
Austria	Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde	Salzburg
Austria	Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik	Wien
Austria	Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie	Wien
Belgium	Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling	Edegem
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	AZ Delta | Clinical Trial Center - Pneumology	Roeselare
Brazil	Fundacao Pio XII - Hospital de Cancer de Barretos	Barretos
Brazil	NAIC - Instituto do Cancer	Bauru
Brazil	Clinica de Oncologia Reichow	Blumenau
Brazil	Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia	Brasilia
Brazil	Pronutrir Fortaleza - CE	Fortaleza
Brazil	Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica	Natal	Rio Grande Do Norte
Brazil	Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology	Porto Alegre - RS	Rio Grande Do Sul
Brazil	Rede DoR Recife - PE	Recife
Brazil	Hospital de Base | Integrated Research Center	São José do Rio Preto	Sao Paulo
Brazil	A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante	Sao Paulo
Brazil	Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima	Sao Paulo
Brazil	Hospital Sirio Libanes	Sao Paulo
Bulgaria	MHAT Uni Hospital	Panagyurishte
Bulgaria	MHAT "Heart and brain" Pleven	Pleven
Bulgaria	Complex Oncology Center - Plovdiv EOOD	Plovdiv
Bulgaria	MHAT Park Hospital EOOD	Plovdiv
Bulgaria	MHAT Serdika	Sofia
Bulgaria	MHAT Sofiamed	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment "Sveta Sofia"	Sofia
Bulgaria	Specialized Hospital for Active Treatment of Oncology	Sofia
Bulgaria	MHAT Sveta Marina EAD	Varna
Canada	Jewish General Hospital - Department of Pulmonary Oncology	Montreal
Canada	Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology	Toronto	Ontario
Canada	BC Cancer - The Vancouver Centre	Vancouver
China	Beijing Cancer Hospital	Beijing
China	Beijing chest hospital, Capital Medical University	Beijing
China	Beijing Hospital	Beijing
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)	Chengdu
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine	Hangzhou	Zhejiang
China	Shandong University - Shandong Cancer Hospital	Jinan
China	NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School	Nanjing	Jiangsu
China	Fudan University - Zhongshan Hospital	Shanghai
China	Shanghai Chest Hospital, Shanghai Jiaotong University	Shanghai
China	Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province	Taizhou
Czechia	Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)	Brno
Czechia	Nemocnice AGEL Novy Jicin a.s., Oddelení radioterapie a onkologie	Novy Jicin
Czechia	Klinika plicnich nemoci a tuberkulozy - Fakultni nemocnice Olomouc	Olomouc
Czechia	Vitkovicka nemocnice a.s.	Ostrava Vitkovice
Czechia	Krajska nemocnice Tomase Bati, a.s. - Pneumoonkologicka a klinicka onkologie	Zlin
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus Universitetshospital	Aarhus N
Denmark	Regionshospitalet Gødstrup	Herning
Denmark	Rigshospitalet	København Ø
Denmark	Odense Universitetshospital (OUH)	Odense
Finland	Docrates Cancer Center	Helsinki
Finland	Turun Yliopistollinen Keskussairaala (TYKS)	Turku
France	Institut Bergonié - Unicancer Nouvelle Aquitaine	Bordeaux
France	Institut de Cancérologie et d'Imagerie	Brest
France	Centre Hospitalier Intercommunal Créteil - Service de pneumologie	Créteil
France	CHU Grenoble Alpes - Pneumologie	La Tronche
France	Institut Coeur Poumon - CHRU Lille - Pôle Cardio-vasculaire et pulmonaire	Lille
France	CHU Limoges - Unité oncologie thoracique	Limoges
France	Hôpital Arnaud de Villeneuve - Montpellier	Montpellier
France	Hôpital Emile Muller - Mulhouse	Mulhouse
France	Hôpital Cochin - Cancérologie	Paris
France	Institut Curie - Ulm - Paris	Paris
France	Hôpital Lyon Sud - HCL - Service de pneumologie aiguë spécialisée et cancérologie thoracique	Pierre Bénite
France	CHU de Rouen - Pneumologie	Rouen
France	Institut de Cancérologie de l'Ouest - Saint Herblain	Saint-Herblain
France	Hôpital Foch - Oncologie digestive et thoracique	Suresnes
France	Institut Gustave Roussy - Département de Médecine Oncologique	Villejuif Cedex
Germany	Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)	Essen
Germany	Universitätsklinikum Giessen und Marburg	Gießen	Hessen
Germany	Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin	Hemer
Germany	Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim	Köln	Nordrhein-Westfalen
Germany	Klinikum Nürnberg	Nürnberg
Germany	Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin	Stuttgart
Greece	Metropolitan Hospital- 4th Oncology Clinic	Athens
Greece	University of Athens Medical School- Alexandra General Hospital of Athens	Athens
Greece	University of Athens Medical School-Sotiria General Hospital	Athens
Greece	University General Hospital ATTIKON	Chaidari
Greece	University General Hospital ATTIKON, Department of Internal Medicine IV	Chaidari
Greece	University General Hospital of Larissa	Larissa
Greece	Bioclinic Thessaloniki	Thessaloniki
Greece	PAPANIKOLAOU General Hospital of Thessaloniki	Thessaloniki
Hong Kong	Queen Elizabeth Hospital Hong Kong	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Hong Kong United Oncology Centre	Kowloon
Hong Kong	Prince of Wales Hospital	Shatin
Hungary	Budapesti Uzsoki Utcai Korhaz	Budapest
Hungary	Komarom-Esztergom Varmegyei Szent Borbala Korhaz	Tatabanya
Israel	Assuta Ashdod	Ashdod
Israel	Soroka Medical Center- Legacy Heritage Cancer Center	Be'er Sheva
Israel	Shaare Zedek Medical Center (SZMC)	Jerusalem
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione-L'Azienda Ospedaliera San Giuseppe Moscati	Avellino
Italy	Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi	Bologna
Italy	IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"	Forlì-Cesena
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano	Lombardia
Italy	IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)	Milano	Lombardia
Italy	Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.	Milano	Lombardia
Italy	Istituto Oncologico Veneto IRCCS (IOV)	Padova	Veneto
Italy	IRCCS Centro di Riferimento Oncologico (CRO)	Pordenone	Friuli-Venezia Giulia
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio
Italy	Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)	Roma
Italy	A.O.U. San Luigi Gonzaga	Torino	Piemonte
Italy	Azienda Ospedaliera Universitaria Integrata Verona (AOUI)	Verona
Japan	Nippon Medical School - Nippon Medical School Hospital - Cancer Center	Bunkyo-ku
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka-shi
Japan	National Hospital Organization Himeji Medical Center	Himeji	Hyogo
Japan	Kansai Medical University Hospital	Hirakata
Japan	National Cancer Center Hospital East	Kashiwa
Japan	Saitama Cancer Center	Kitaadachi-gun	Saitama
Japan	Kobe University Hospital	Kobe
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Osaka International Cancer Institute	Osaka-shi
Japan	Kindai University Hospital	Osakasayama-shi
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Hokkaido University Hospital	Sapporo
Japan	Sendai Kousei Hospital	Sendai	Miyagi
Japan	National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital)	Ube
Japan	Tottori University Hospital	Yonago	Tottori
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbugdo
Korea, Republic of	Chonnam National University Hwasun Hospital	Gwangju
Korea, Republic of	Gyeongsang National University Hospital	Jinju-si
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan-si	Gyeongsangnamdo
Mexico	Oncare Viaducto Nápoles	Cdmx
Mexico	Instituto Nacional de Cancerología	México	Distrito Federal
Mexico	Oncología Integral Satélite	Naucalpan
Mexico	ONCARE Treatment Center	San Pedro Garza García
Netherlands	Nederlands Kanker Instituut	Amsterdam
Netherlands	Radboud University Medical Center | Afdeling Interne Geneeskunde	Nijmegen
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Swietokrzyskie Centrum Onkologii	Kielce
Poland	SP ZOZ USK im. WAM UM w Lodzi - Centralny Szpital Weteranow	Lodz
Poland	Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku	Otwock
Poland	Wielkopolskie Centrum Pulmonologii i Torakochirurgii	Poznan
Poland	Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii	Wroclaw
Portugal	CHULN - Hospital Pulido Valente	Lisboa
Portugal	Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica	Lisboa
Portugal	ULSM - Hospital Pedro Hispano	Matosinhos	Porto
Portugal	IPO Porto	Porto
Romania	Spitalul Clinic Coltea	Bucharest
Romania	Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicala II	Bucuresti
Romania	Centrul de Oncologie Sfantul Nectarie	Craiova
Romania	Sc Oncolab Srl	Craiova
Romania	Radiotherapy Center Cluj SRL	Flore¿ti
Singapore	Curie Oncology | Farrer	Singapore
Singapore	OncoCare Cancer Centre	Singapore
Singapore	Raffles Cancer Centre	Singapore
Slovakia	POKO Poprad s.r.o.	Poprad
Slovakia	Fakultna nemocnica Trnava	Trnava
Spain	Complejo Hospitalario Universitario A Coruna (CHUAC)	A Coruna
Spain	Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location	Badalona
Spain	Complejo Hospitalario de Navarra	Barañaín	Navarra
Spain	Ciutat Sanitaria i Universitaria de la Vall d'Hebron	Barcelona
Spain	Hospital Clinic de Barcelona (Hospital Clinic i Provincial)	Barcelona
Spain	Hospital Quiron Dexeus	Barcelona
Spain	Fundacion Jimenez Diaz (Clinica de la Concepcion)	Madrid
Spain	Hospital General Universitario Gregorio Maranon | Oncologia	Madrid
Spain	Hospital Universitario Clinica Puerta de Hierro	Majadahonda	Madrid
Spain	Fundacion Instituto Valenciano de Oncologia (IVO	Valencia
Spain	Hospital Universitari i Politecnic La Fe | Oncologia	Valencia
Sweden	Skåne University Hospital	Lund
Sweden	Norrland University Hospital - Cancercentrum	Umeå
Switzerland	Kantonsspital Baden	Baden
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City	Kaohsiung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi-Mei Medical Center, Liouyine	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Turkey	Adana Sehir Egitim ve Arastirma Hastanesi	Adana
Turkey	Ankara Bilkent Sehir Hastanesi	Bilkent Çankaya
Turkey	Marmara University Hospital	Istanbul
Turkey	Ege Universitesi Tip Fakultesi	Izmir
Turkey	Istanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçin Sehir Hastanesi	Kadikoy
Turkey	I.A.Ü. VM Medical Park Florya Hastanesi	Kucukcekmece
Turkey	Sakarya Universitesi Egitim ve Arastirma Hastanesi	Sakarya
Turkey	Ankara Etlik Sehir Hastanesi	Yenimahalle
United Kingdom	Belfast City Hospital	Belfast	North Ireland
United Kingdom	Royal Surrey County Hospital	Guildford	Surrey
United Kingdom	Torbay Hospital	Torquay
United States	University of Maryland	Baltimore	Maryland
United States	The U Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois
United States	Profound Research LLC	Farmington Hills	Michigan
United States	Northwell Health Cancer Institute - R.J. Zuckerberg Cancer Center (Monter Cancer Center) - Center for Advanced Medicine Location	New Hyde Park	New York
United States	Hoag Memorial Hospital - Center for Research & Education	Newport Beach	California
United States	Providence Cancer Institute - Franz Clinic	Portland	Oregon
United States	University of California Los Angeles (UCLA) - Cancer Care - Santa Monica	Santa Monica	California
United States	The Oncology Institute of Hope and Innovation	Whittier	Florida
United States	UMass Memorial Medical Center - University Campus	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS) per RECIST 1.1 as assessed by BICR	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)	Up to approximately 2 years
Secondary	Overall survival (OS)		Up to approximately 4 years
Secondary	Objective response rate (ORR) per RECIST 1.1 as assessed by BICR	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)	Up to approximately 4 years
Secondary	Progression free survival (PFS) per RECIST 1.1 as assessed by the investigator	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1	Up to approximately 4 years
Secondary	Objective Response Rate (ORR) as assessed by the investigator		Up to approximately 4 years
Secondary	Disease control rate (DCR) per RECIST 1.1 as assessed by BICR	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)	Up to approximately 4 years
Secondary	Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator	RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1	Up to approximately 4 years
Secondary	Duration of response (DOR) as assessed by BICR	BICR = blinded independent central review (BICR)	Up to approximately 4 years
Secondary	Duration of response (DOR) as assessed by the investigator		Up to approximately 4 years
Secondary	Adverse events per CTCAE v 5.0 (eg. TEAEs, TESAEs) categorized by severity	CTCAE = common terminology criteria for adverse events; TEAE = treatment-emergent adverse event; TESAE = treatment-emergent serious adverse event	Up to approximately 4 years
Secondary	Change from baseline in NSCLC-SAQ total score	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire	Up to approximately 4 years
Secondary	Change from baseline in NSCLC-SAQ individual domain scores	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire; Domains: cough, pain, dyspnea, fatigue, appetite	Up to approximately 4 years
Secondary	Time to deterioration in NSCLC-SAQ total score	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire	Up to approximately 4 years
Secondary	Time to deterioration in NSCLC-SAQ individual domain scores	NSCLC-SAQ = Non-small cell lung cancer Symptom Assessment Questionnaire; Domains: cough, pain, dyspnea, fatigue, appetite	Up to approximately 4 years
Secondary	Time to deterioration in EORTC QLQ-C30 physical functioning domain score	EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30	Up to approximately 4 years
Secondary	Change from baseline in EORTC QLQ-C30 physical functioning domain score	EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QoL: quality of life	Up to approximately 4 years
Secondary	Change from baseline in EORTC QLQ-C30 global health status/QoL	EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QoL: quality of life	Up to approximately 4 years

External Links

•   Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.