A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

— SKYSCRAPER-01  

Official title:

A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04294810
• Other study ID #: GO41717
• Secondary ID: 2019-002925-3120
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 4, 2020
• Est. completion date: February 21, 2025

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 620
• Est. completion date: February 21, 2025
• Est. primary completion date: February 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC

• No prior systemic treatment for metastatic NSCLC

• High tumor tissue PD-L1 expression

• Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

• Adequate hematologic and end-organ function

• For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.

Exclusion Criteria:

• Known mutation in the EGFR gene or an ALK fusion oncogene

• Symptomatic, untreated, or actively progressing central nervous system metastases

• Active or history of autoimmune disease or immune deficiency

• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis

• Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome

• Severe infection within 4 weeks prior to initiation of study treatment

• Positive test result for human immunodeficiency virus (HIV)

• Active hepatitis B or hepatitis C

• Treatment with investigational therapy within 28 days prior to initiation of study treatment

• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies

• Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Atezolizumab
Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
• Tiragolumab
Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
• Matching Placebo
Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
Australia	Austin Hospital Olivia Newton John Cancer Centre	Heidelberg	Victoria
Australia	Peter Maccallum Cancer Centre	Melbourne	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	Ordensklinikum Linz Elisabethinen	Linz
Austria	Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten	Wien
Austria	Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie	Wien
Brazil	Hospital de Cancer de Barretos	Barretos	SP
Brazil	Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda	Ijui	RS
China	Beijing Cancer Hospital	Beijing
China	Beijing Chest Hospital; Oncology Department	Beijing
China	The First Hospital of Jilin University	Changchun City
China	Changzhou First People's Hospital	Changzhou
China	West China Hospital, Sichuan University	Chengdu
China	Sichuan Cancer Hospital	Chengdu City
China	Chongqing Cancer Hospital	Chongqing
China	Fujian Cancer Hospital	Fuzhou
China	Cancer Center of Guangzhou Medical University	Guangzhou
China	Hainan General Hospital	Haikou
China	Sir Run Run Shaw Hospital Zhejiang University	Hangzhou City
China	Harbin Medical University Cancer Hospital	Harbin
China	Jinan Central Hospital	Jinan City
China	Meizhou People's Hospital	Meizhou City
China	The 1st Affiliated Hospital of Nanchang Unversity	Nanchang
China	The Second Affiliated Hospital to Nanchang University	Nanchang
China	Nantong Tumor Hospital	Nantong City
China	Shanghai Pulmonary Hospital	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai City
China	Tianjin Cancer Hospital	Tianjin
China	Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology	Wuhan City
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	The First Affiliated Hospital of Xiamen University	Xiamen
China	Zhejiang Cancer Hospital	Zhejiang
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Rigshospitalet; Onkologisk Klinik	København Ø
Denmark	Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed	Roskilde
Germany	Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie	Frankfurt
Germany	LungenClinic Großhansdorf GmbH; Klinische Forschung	Großhansdorf
Germany	Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I	Halle (Saale)
Germany	Fachklinik für Lungenerkrankungen	Immenhausen
Germany	SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal	Löwenstein
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie	Münster
Germany	Klinik Schillerhöhe; Pneumologische Onkologie	Stuttgart
Greece	Metropolitan Hospital	Athens
Greece	Sotiria Hospital	Athens
Greece	University Hospital of Larissa;Department of Medical Oncology	Larissa
Greece	Diavalkaniko Hospital	Thessaloniki
Hungary	Orszagos Koranyi TBC es Pulmonologiai Intezet	Budapest
Hungary	Matrai Gyogyintezet	Matrahaza
Hungary	Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály	Szolnok
Italy	Azienda Ospedaliera San Giuseppe Moscati	Avellino	Campania
Italy	Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia	Milano	Lombardia
Italy	Asst Di Monza	Monza	Lombardia
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale	Napoli	Campania
Italy	Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO)	Orbassano	Piemonte
Italy	IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II	Padova	Veneto
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma	Lazio
Italy	Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica	Roma	Lazio
Italy	Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia	Rozzano	Lombardia
Italy	Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica	Sant'Andrea Delle Fratte (PG)	Umbria
Japan	Aichi Cancer Center	Aichi
Japan	National Cancer Center Hospital East	Chiba
Japan	Kyushu University Hospital	Fukuoka
Japan	Sendai Kousei Hospital	Miyagi
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Kindai University Hospital	Osaka
Japan	Osaka International Cancer Institute	Osaka
Japan	Saitama Cancer Center	Saitama
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center	Sakai-shi
Japan	Shizuoka Cancer Center	Shizuoka
Japan	National Cancer Center Hospital	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Korea, Republic of	Chungbuk National University Hospital	Cheongju si
Korea, Republic of	Ajou University Medical Center	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	St. Vincent's Hospital	Suwon
Mexico	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)
Mexico	Cryptex Investigacion Clinica SA de CV	Mexico	Mexico CITY (federal District)
Mexico	AVIX Investigación Clínica S.C	Monterrey	Nuevo LEON
Mexico	Cuidados oncologicos	Querétaro	Queretaro
Netherlands	Jeroen Bosch Ziekenhuis	'S Hertogenbosch
Netherlands	Hagaziekenhuis, locatie Leyweg	Den-Haag
Netherlands	Ziekenhuis Gelderse Vallei	EDE
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Peru	Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica	Arequipa
Peru	Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional	Lima
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Peru	Clinica Ricardo Palma	San Isidro
Poland	Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii	Gdansk
Poland	Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii	Olsztyn
Poland	Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii	Otwock
Poland	Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu	Poznan
Russian Federation	Main Military Clinical Hospital named after N.N. Burdenko	Moscow	Moskovskaja Oblast
Russian Federation	MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy	Moscow	Moskovskaja Oblast
Russian Federation	City Clinical Hospital #1	Novosibirsk
Russian Federation	Institute of Oncology	St Petersburg	Sankt Petersburg
Russian Federation	Leningrad Regional Clinical Hospital	St Petersburg	Sankt Petersburg
Russian Federation	St. Petersburg Clinical Scientific Center of special services medical assis (oncology)	ST Petersburg	Sankt Petersburg
Russian Federation	St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research	St Petersburg	Sankt Petersburg
Russian Federation	Regional Clinical Oncology Hospital	Yaroslavl
Serbia	Clinical Center of Serbia	Belgrade
Serbia	University Hospital Medical Center Bezanijska kosa	Belgrade
Serbia	Institute for pulmonary diseases of Vojvodina	Sremska Kamenica
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital 12 de Octubre; Servicio de Digestivo	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid
Spain	Hospital Regional Universitario de Malaga	Malaga
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hosp Clinico Univ Lozano Blesa; División De Oncología Médica	Zaragoza
Switzerland	Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit	Bern
Switzerland	CHUV; Departement d'Oncologie	Lausanne
Switzerland	Kantonsspital St.Gallen Medizin Onkologie; Klinik fuer Onkologie und Haematologie	St. Gallen
Taiwan	Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	Taipei Medical University ?Shuang Ho Hospital	New Taipei City
Taiwan	Taichung Veterans General Hospital; Dept of Internal Medicine	Taichung
Taiwan	National Cheng Kung Uni Hospital; Dept of Hematology and Oncology	Tainan
Taiwan	Chang Gung Memorial Hospital - Linkou Branch	Taipei
Taiwan	Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology	Taipei
Taiwan	National Taiwan University Hospital; Oncology	Zhongzheng Dist.
Thailand	Chulalongkorn Hospital; Medical Oncology	Bangkok
Thailand	Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology	Bangkok
Thailand	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok
Thailand	Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory	Songkhla
Turkey	Adana Baskent University Hospital; Medical Oncology	Adana
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Istanbul University Cerrahpasa Faculty of Medicine	Istanbul
Turkey	Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi	Izmir
Turkey	Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology	Kadiköy
Turkey	Inonu University Medical Faculty of Medicine; Medical Oncology Department	Malatya
Turkey	Medical Park Seyhan Hospital; Oncology Department	Seyhan
Ukraine	City Clinical Hospital #4	Dnipropetrovsk
Ukraine	Ivano-Frankivsk Regional Oncology Center	Ivano-Frankivsk
Ukraine	ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department	Kryvyi Rih
Ukraine	Uzhgorod Nat. University Central Municip Hosp; Onc Center	Uzhgorod
United States	Virginia Cancer Specialists (Fairfax) - USOR	Fairfax	Virginia
United States	Rocky Mountain Cancer Center - Denver	Littleton	Colorado
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Yale Cancer Center	New Haven	Connecticut
United States	US oncology research at Minnesota Oncology	Saint Paul	Minnesota
United States	SCRI Florida Cancer Specialists North; Research Office North Region.	Saint Petersburg	Florida
United States	Onc & Hem Assoc SW Virginia	Salem	Virginia
United States	SCRI Florida Cancer Specialists PAN	Tallahassee	Florida
United States	Northwest Cancer Specialists - Vancouver	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  China,  Denmark,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Peru,  Poland,  Russian Federation,  Serbia,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set		From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Primary	Overall Survival (OS) in the Primary Analysis Set		From randomization to death from any cause (up to approximately 59 months)
Primary	Percentage of Participants With Adverse Events (AEs)		Up to approximately 59 months
Primary	Percentage of Participants With Cytokine-Release Syndrome (CRS)		Up to approximately 59 months
Secondary	Investigator-Assessed PFS in the Secondary Analysis Set		From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Secondary	OS in the Secondary Analysis Set		From randomization to death from any cause (up to approximately 59 months)
Secondary	Investigator-Assessed Confirmed Objective Response Rate (ORR)		From randomization up to approximately 59 months
Secondary	Investigator-Assessed Duration of Response (DOR)		From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Secondary	Investigator-Assessed PFS Rates at 6 Months and 12 Months		6 months, 12 months
Secondary	OS Rates at 12 Months and 24 Months		12 months, 24 months
Secondary	Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score	TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.	From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)