A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer (SKYSCRAPER-06)

A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).

Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase:

• Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin
• Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin

Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Tiragolumab; Drug: Atezolizumab; Drug: Tiragolumab Matching Placebo; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: Pembrolizumab

• Study Type: Interventional
• Enrollment (Actual): 542
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BO42592 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Onze Lieve Vrouwziekenhuis Aalst
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis
  • Liège, Belgium, 4000
    • CHU de Liège
  • Mont-godinne, Belgium, 5530
    • CHU UCL Mont-Godinne
  • Sint Niklaas, Belgium, 9100
    • Vitaz
• Brazil
  • CE
    • Fortaleza, CE, Brazil, 60336-232
      • Crio - Centro Regional Integrado de Oncologia
  • MG
    • Belo Horizonte, MG, Brazil, 30360-680
      • Oncocentro Belo Horizonte
  • RS
    • Ijui, RS, Brazil, 98700-000
      • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS
    • Porto Alegre, RS, Brazil, 90040-373
      • Hospital Nossa Senhora da Conceicao
  • SP
    • Barretos, SP, Brazil, 14784-400
      • Hospital de Cancer de Barretos
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre
    • London, Ontario, Canada, N6A 4G5
      • Victoria Hospital - London Health Sciences Centre
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Oshawa
    • Sault Ste. Marie, Ontario, Canada, P6B 0A8
      • Sault Area Hospital; Algoma District Cancer Program
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Universite de Montreal - Hopital Maisonneuve-Rosemont
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Changchun, China, 132013
    • Jilin Cancer Hospital
  • Changsha City, China, 410008
    • Xiangya Hospital Central South University
  • Changzhou, China, 213003
    • Changzhou First People's Hospital; Oncology
  • Chengde City, China, 067020
    • Affiliated Hospital of Chengde Medical University
  • Chengdu City, China, 610047
    • West China Hospital - Sichuan University
  • Chengdu City, China, 610041
    • Sichuan Cancer Hospital
  • Dongguan, China, 511700
    • Dongguan People's Hospital
  • Hefei, China, 230088
    • Anhui Provincial Hospital; Respiratory Department
  • Jinan City, China, 250013
    • Jinan Central Hospital
  • Linyi City, China, 276034
    • Linyishi Cancer Hospital
  • Pingxiang City, China, 337000
    • Pingxiang People Hospital
  • Qingdao City, China, 266042
    • Qingdao Central Hospital; Department of Respiratory and Critical Care Medicine
  • Weifang City, China, 261041
    • Weifang People's Hospital
  • Wuhan, China, 430079
    • Hubei Cancer Hospital
  • Xi'an City, China, 710061
    • The First Affiliated Hospital of Xian Jiao Tong University
  • Xinxiang City, China, 453000
    • The First Affiliated Hospital of Xinxiang Medical University
  • Zhengzhou, China, 450052
    • The First Affiliated Hospital of Zhengzhou University
• Denmark
  • København Ø, Denmark, 2100
    • Rigshospitalet; Onkologisk Klinik
  • Odense C, Denmark, 5000
    • Odense Universitetshospital, Onkologisk Afdeling R
  • Roskilde, Denmark, 4000
    • Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed
• France
  • Bordeaux, France, 33076
    • Institut Bergonie; Pneumology
  • Marseille cedex 20, France, 13915
    • Hopital Nord; Pneumologie
  • Rennes, France, 35033
    • Hopital de Pontchaillou; Service de Pneumologie
  • Strasbourg, France, 67091
    • CHU Strasbourg - Nouvel Hopital Civil
  • Toulouse cedex 9, France, 31100
    • CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
• Germany
  • Berlin, Germany, 14165
    • Helios Klinikum Emil von Behring GmbH
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Karlsruhe, Germany, 76137
    • St. Vincentius Kliniken Karlsruhe
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
  • Marburg, Germany, 35032
    • Klinikum der Philipps-Universität Marburg
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital; Medicine & Respiratory
  • Hong Kong, Hong Kong
    • Queen Mary Hospital; Dept. of Clinical Oncology
  • Hong Kong, Hong Kong
    • Tuen Mun Hospital; Clinical Onc
  • Hong Kong, Hong Kong
    • Hong Kong United Oncology Centre
  • Shatin, Hong Kong
    • Prince of Wales Hospital; Department of Clinical Onocology
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
  • Friuli-Venezia Giulia
    • Aviano, Friuli-Venezia Giulia, Italy, 33081
      • Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
  • Liguria
    • Genova, Liguria, Italy, 16149
      • A.O. Villa Scassi; Oncologia Medica
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • Asst Papa Giovanni XXIII; Oncologia Medica
    • Brescia, Lombardia, Italy, 25123
      • ASST Spedali Civili di Brescia
  • Toscana
    • Firenze, Toscana, Italy, 50139
      • Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
• Japan
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Fukuoka, Japan, 830-0011
    • Kurume University Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hyogo, Japan, 665-0827
    • Takarazuka City Hospital
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Miyagi, Japan, 980-0873
    • Sendai Kousei Hospital
  • Osaka, Japan, 589-8511
    • Kindai University Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Osaka, Japan, 573-1191
    • Kansai Medical University Hospital
  • Osaka, Japan, 591-8555
    • Kinki-chuo Chest Medical Center
  • Saitama, Japan, 362-0806
    • Saitama Cancer Center
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Tokyo, Japan, 193-0998
    • Tokyo Medical University Hachioji Medical Center
  • Wakayama, Japan, 641-8510
    • Wakayama Medical University Hospital
• Kenya
  • Eldoret, Kenya, 30100
    • International Cancer Institute (ICI)
• Korea, Republic of
  • Busan, Korea, Republic of, 49267
    • Kosin University Gospel Hospital
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Chilgok Hospital
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Gyeonggi-do, Korea, Republic of, 16247
    • St. Vincent's Hospital
  • Gyeongsangnam-do, Korea, Republic of, 51353
    • Samsung Changwon Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 06591
    • Seoul St Mary's Hospital
• Mexico
  • Ciudad de México, Mexico, 06700
    • ARKE Estudios Clínicos S.A. de C.V.
  • Mexico CITY (federal District)
    • Cdmx, Mexico CITY (federal District), Mexico, 03100
      • Health Pharma Professional Research
  • Queretaro
    • Querétaro, Queretaro, Mexico, 76000
      • Cuidados Oncologicos
  • SAN LUIS Potosi
    • San Luis Potosí, SAN LUIS Potosi, Mexico, 78209
      • Oncologico Potosino
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital, Cancer and Blood Research
  • Hamilton, New Zealand, 3204
    • Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre
  • Palmerston North, New Zealand, 4410
    • Palmerston North Hospital
  • Tauranga, New Zealand, 3112
    • Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
• Poland
  • ?ód?, Poland, 90-338
    • Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
  • Olsztyn, Poland, 10-357
    • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar; Servicio de Oncologia
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona; Servicio de oncologia
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti; Servicio de Oncologia
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Servicio de Oncologia
  • Sevilla, Spain, 41014
    • Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • ICO L'Hospitalet; Servicio de oncologia medica
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Hospital Son Llatzer; Servicio de Oncologia
  • LA Coruña
    • A Coruña, LA Coruña, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
      • Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia
• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau
  • Chur, Switzerland, 7000
    • Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
  • Zürich, Switzerland, 8091
    • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
• Taiwan
  • Chang Hua, Taiwan, 500
    • Changhua Christian Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei City, Taiwan, 11217
    • Taipei Veterans General Hospital
• Thailand
  • Bangkok, Thailand, 10400
    • Pramongkutklao Hospital; Medicine - Medical Oncology Unit
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital; Medical Oncology
  • Bangkok, Thailand, 10700
    • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Bangkok, Thailand, 10300
    • Vajira Hospital
  • ChiangMai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital; Department of Medicine
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
• Turkey
  • Adana, Turkey, 01220
    • Adana Baskent University Medical Faculty; Oncology
  • Ankara, Turkey, 06490
    • Ankara Bilkent City Hospital
  • Ankara, Turkey, 06680
    • Liv Hospital Ankara; Medical Oncology
  • Diyarbakir, Turkey, 21280
    • Dicle University Faculty of Medicine
  • Edirne, Turkey, 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey, 34000
    • Istanbul University Cerrahpasa Medical Faculty
  • Kadiköy, Turkey, 34722
    • Medeniyet University Goztepe Training and Research Hospital.
• United Kingdom
  • Cornwall, United Kingdom, TR1 3LQ
    • Royal Cornwall Hospital; Dept of Clinical Oncology
  • Hull, United Kingdom, HU16 5JQ
    • Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
  • London, United Kingdom, EC1A 7BE
    • Barts & London School of Med; Medical Oncology
  • London, United Kingdom, SE1 9RT
    • Guy'S Hospital; Oncology Unit
  • Manchester, United Kingdom, M2O 4BX
    • Christie Hospital Nhs Trust; Medical Oncology
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
    • Torrance, California, United States, 90505
      • Torrance Memorial Physician Network/Cancer Care
    • Whittier, California, United States, 90602
      • PIH Health Whittier Hospital; NC
  • Florida
    • Fort Myers, Florida, United States, 33916
      • Scri Florida Cancer Specialists South
    • Orlando, Florida, United States, 32804
      • Advent Health Orlando
    • Saint Petersburg, Florida, United States, 33705
      • SCRI Florida Cancer Specialists North; Research Office North Region.
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers PC - Marietta
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology and Hematology, Inc
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology Chattanooga
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Res. Inst. Onc.
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute; Inova Schar Cancer Institute Infusion Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
• No prior systemic treatment for metastatic non-squamous NSCLC
• Known tumor programmed death-ligand 1 (PD-L1) status
• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
• Life expectancy >= 12 weeks
• Adequate hematologic and end-organ function
• Negative human immunodeficiency virus (HIV) test at screening
• Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.

Key Exclusion Criteria:

• Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene
• Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
• Symptomatic, untreated, or actively progressing central nervous system (CNS) 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
• History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death
• Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 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 (whichever is longer) prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
• Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study
• Women who are pregnant, or breastfeeding
• Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or Cisplatin; Induction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle.	Drug: Tiragolumab; Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.; Other Names: MTIG7192A; Drug: Atezolizumab; Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.; Other Names: Tecentriq; Drug: Pemetrexed; Pemetrexed 500 milligrams per square meter (mg/m^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.; Drug: Carboplatin; Carboplatin at dose of area under the concentration-time curve (AUC) of 5, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.; Drug: Cisplatin; Cisplatin 75 mg/m^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
Placebo Comparator: Placebo+Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin; Induction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed on Day 1 of each 21-day cycle.	Drug: Tiragolumab Matching Placebo; Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.; Drug: Pemetrexed; Pemetrexed 500 milligrams per square meter (mg/m^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.; Drug: Carboplatin; Carboplatin at dose of area under the concentration-time curve (AUC) of 5, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.; Drug: Cisplatin; Cisplatin 75 mg/m^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.; Drug: Pembrolizumab; Pembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Investigator-Assessed Confirmed Objective Response Rate (ORR) (Phase 2)	Up to approximately 5 years
Investigator-Assessed Progression-Free Survival (PFS) (Phase 2 and Phase 3)	From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 5 years [Phase 2], up to approximately 7 years [Phase 3])
Overall Survival (Phase 3)	From randomization to death from any cause (up to approximately 7 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (Phase 2)		From randomization to death from any cause (up to approximately 5 years)
PFS as Determined by an Independent Review Facility (IRF) (Phase 3)		From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 7 years)
Investigator-assessed PFS in Participants With PD-L1 Expression at TC ≥50% and TC ≥1% Cut-off, as Determined by Central Testing With Ventana PD-L1 (SP263) Assay (Phase 3)		From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 7 years)
OS in Participants With PD-L1 Expression at TC ≥50% and TC ≥1% Cut-off, as Determined by Central Testing With Ventana PD-L1 (SP263) Assay (Phase 3)		From randomization to death from any cause (up to approximately 7 years)
Investigator-Assessed PFS at 6 Months and 12 Months (Phase 3)		6 months, 12 months
OS Rate at 12 Months and 24 Months (Phase 3)		12 months, 24 months
Investigator-Assessed Confirmed ORR (Phase 3)		Up to approximately 7 years
Investigator-Assessed Duration of Response (DOR) (Phase 2 and Phase 3)		From first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) as Measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (Phase 2 and Phase 3)	TTCD using EORTC Quality-of-Life Questionnaire Core 30 (QLQ-C30) is an initial 10-point decrease in GHS and physical 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/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.	Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
TTCD in Participant-Reported Lung Cancer Symptoms for Cough, Dyspnea, and Chest Pain, as Measured by EORTC QLQ-LC13 (Phase 2 and Phase 3)	TTCD using EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13) is an initial 10-point increase in symptom score 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-LC13 consists of 13 lung cancer specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Each item is scored on a 4-point scale of 1=Not at all to 4=Very much. Scores will be linearly transformed to a score range of 0 to 100. Higher score indicates worsening of symptoms.	Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Percentage of Participants With Adverse Events (AEs) (Phase 2 and Phase 3)		Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Participants' Response to Side Effects of Treatment as Assessed by EORTC IL46 (Phase 2 and Phase 3)	EORTC Item List 46 (IL46) is a validated single-item question that assesses overall side effect impact. Each item is scored on a 4-point scale of 1=Not at all to 4=Very much. Scores will be linearly transformed to a score range of 0 to 100. Higher score indicates a worse outcome.	Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3)
Serum Concentration of Tiragolumab (Phase 2 and Phase 3)		Cycle 1 (each cycle=21 days), Day 1: predose, 0.5 hour (h) postdose; Cycles 2, 3, 4, 8, 12, 16, Day 1: predose and at treatment discontinuation (TD) visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Serum Concentration of Atezolizumab (Phase 2 and Phase 3)		Cycle 1 (each cycle=21 days), Day 1: predose, 0.5 hour (h) postdose; Cycles 2, 3, 4, 8, 12, 16, Day 1: predose and at TD visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab (Phase 2 and Phase 3)		Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])
Percentage of Participants With ADAs to Atezolizumab (Phase 2 and Phase 3)		Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3])

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): May 14, 2027

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Carboplatin; Pembrolizumab; Pemetrexed; Atezolizumab
• Other Study ID Numbers: BO42592; 2020-002851-39 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No