A 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

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

  • Cancer
  • Lung Cancer
  • Non‑Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Active, not recruiting

This study runs in
Cities
  • Aalst
  • Aarau
  • Adana
  • Ankara
  • Auckland
  • Aviano
  • Bangkok
  • Barcelona
  • Barretos
  • Barrie
  • Beijing
  • Bordeaux
  • Bruxelles
  • Busan
  • Cdmx
  • Chang Hua
  • Changchun
  • Changsha City
  • Changzhou Shi
  • Chattanooga
  • Chemnitz
  • chengde-city
  • Chengdu City
  • ChiangMai
  • Chur
  • Ciudad de México
  • Daegu
  • Daejeon
  • Diyarbakir
  • Edirne
  • Edmonton
  • Fairfax
  • Firenze
  • Fort Myers
  • Fort Wayne
  • Fortaleza
  • Fukuoka
  • Genova
  • Gyeonggi-do
  • Gyeongsangnam-do
  • Hefei Shi
  • Hiroshima
  • Hong Kong
  • Hull
  • Hyogo
  • Ijui
  • Istanbul
  • Jinan City
  • kadikoey
  • Karlsruhe
  • Kyoto
  • København Ø
  • L'Hospitalet de Llobregat
  • La Coruna
  • Las Palmas de Gran Canaria
  • Lexington
  • Lodz
  • London
  • Los Angeles
  • Lugo
  • Madrid
  • Mainz
  • Manchester
  • Marburg
  • Marietta
  • Marseille cedex 20
  • Minas Gerais
  • Miyagi
  • Mont-godinne
  • Nottingham
  • Odense C
  • Olsztyn
  • Osaka
  • Oshawa
  • Palma De Mallorca
  • Palmerston North
  • pingxiang-city
  • Porto Alegre
  • qingdao-city
  • Queretaro
  • Rennes
  • Roskilde
  • Saint Petersburg
  • Saitama
  • San Luis Potosí
  • Sault Ste. Marie
  • Seoul
  • Sevilla
  • Shatin
  • Sint-Niklaas
  • Songkhla
  • Strasbourg
  • São Paulo
  • Taichung
  • Taipei City
  • Tauranga
  • Tokyo
  • Torrance
  • Toulouse cedex 9
  • València
  • Wakayama
  • weifang-city
  • Whittier
  • Winter Park
  • Wuhan
  • Xi'an City
  • xinxiang-city
  • Zhengzhou Shi
  • Zürich
Trial Identifier:

NCT04619797 2022-502031-20-00 BO42592

  • A.O. Villa Scassi

    1 Corso Onofrio Scassi16149GenovaItaly
  • Adana Baskent University Medical Faculty

    01220AdanaTurkey
  • Advent Health Orlando

    601 E Rollins St32789Winter ParkUnited States
  • Affiliated Hospital of Chengde Medical University

    067020chengde-cityChina
  • Anhui Provincial Hospital

    230088Hefei ShiChina
  • Ankara Bilkent City Hospital

    No:9 1604. Cd06490AnkaraTurkey
  • ARKE Estudios Clínicos S.A. de C.V.

    90 Cozumel06700Ciudad de MéxicoMexico
  • Asan Medical Center

    05505SeoulKorea, Republic of
  • Auckland City Hospital, Cancer and Blood Research

    2 Park Rd1023AucklandNew Zealand
  • Azienda Ospedaliero-Universitaria Careggi

    1 Largo Piero Palagi50139FirenzeItaly
  • AZORG Campus Aalst-Moorselbaan

    9300AalstBelgium
  • Baptist Health Lexington

    1740 Nicholasville Rd40503LexingtonUnited States
  • Barts & London School of Med

    EC1A 7BELondonUnited Kingdom
  • Beijing Cancer Hospital

    52 Fu Cheng Lu100142BeijingChina
  • Castle Hill Hospital

    HU16 5JQHullUnited Kingdom
  • Centro Di Riferimento Oncologico

    2 Via Franco Gallini33081AvianoItaly
  • Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

    66 Przędzalniana90-242LodzPoland
  • Changhua Christian Hospital

    176 Zhonghua Rd500Chang HuaTaiwan
  • Changzhou First People's Hospital

    213003Changzhou ShiChina
  • China Medical University Hospital

    40447TaichungTaiwan
  • Christie Hospital Nhs Trust

    M2O 4BXManchesterUnited Kingdom
  • CHU de Toulouse - Hôpital Larrey

    2 Rue Charles Viguerie31100Toulouse cedex 9France
  • CHU Strasbourg - Nouvel Hopital Civil

    67091StrasbourgFrance
  • CHU UCL Mont-Godinne

    1 Rue Dr Gaston Therasse5530Mont-godinneBelgium
  • Chulalongkorn Hospital

    1873 Thanon Rama IV10330BangkokThailand
  • Chungnam National University Hospital

    35015DaejeonKorea, Republic of
  • Cliniques Universitaires St-Luc

    10 Av. Hippocrate1200BruxellesBelgium
  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    84 Xubias15006La CorunaSpain
  • Complejo Hospitalario Universitario Insular?Materno Infantil

    s/n Avenida Marítima del Sur35016Las Palmas de Gran CanariaSpain
  • Crio - Centro Regional Integrado de Oncologia

    1300 R. Francisco Calaça60336-550FortalezaBrazil
  • Cross Cancer Institute

    11560 University AveT6G 1Z2EdmontonCanada
  • Cuidados oncologicos

    76000QueretaroMexico
  • Dicle University Faculty of Medicine

    21280DiyarbakirTurkey
  • Faculty of Med. Siriraj Hosp.

    2 Thanon Wang Lang10700BangkokThailand
  • Fort Wayne Medical Oncology and Hematology, Inc

    7910 W Jefferson Blvd46804Fort WayneUnited States
  • Guy'S Hospital

    SE1 9RTLondonUnited Kingdom
  • Health Pharma Professional Research

    662 Av. Insurgentes Sur03100CdmxMexico
  • Hiroshima University Hospital

    734-8551HiroshimaJapan
  • Hong Kong United Oncology Centre

    Hong KongHong Kong
  • Hopital de Pontchaillou

    35033RennesFrance
  • Hopital Nord

    13915Marseille cedex 20France
  • Hospital Clinic Barcelona

    170 Carrer de Villarroel08036BarcelonaSpain
  • Hospital Clinico Universitario de Valencia

    17 Av. de Blasco Ibáñez46010ValènciaSpain
  • Hospital das Clinicas - UFRGS

    90035-903Porto AlegreBrazil
  • Hospital de Cancer de Barretos

    1331 R. Antenor Duarte Viléla14784-400BarretosBrazil
  • Hospital del Mar

    08003BarcelonaSpain
  • Hospital General Universitario Gregorio Marañon

    46 C. del Dr. Esquerdo28007MadridSpain
  • Hospital Lucus Augusti

    1 Rúa Dr. Ulises Romero27003LugoSpain
  • Hospital Nossa Senhora da Conceicao

    596 Av. Francisco Trein91350-200Porto AlegreBrazil
  • Hospital Son Llatzer

    km 4 C. de Manacor07198Palma De MallorcaSpain
  • Hospital Univ. Nuestra Señora de Valme

    11 C. Ambrosio de la Cuesta41014SevillaSpain
  • Hospital Universitario La Paz

    261 P.º de la Castellana28046MadridSpain
  • Hubei Cancer Hospital

    16 Zhuo Dao Quan Nan Lu430079WuhanChina
  • ICO L'Hospitalet

    199 Avinguda de la Granvia de l’Hospitalet08908L'Hospitalet de LlobregatSpain
  • Inova Schar Cancer Institute

    8081 Innovation Park Dr22031FairfaxUnited States
  • Institut Bergonie

    33076BordeauxFrance
  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    251 Av. Dr. Arnaldo01246-000São PauloBrazil
  • Istanbul University Cerrahpasa Medical Faculty

    No:53 Koca Mustafapaşa Cd.34000IstanbulTurkey
  • Jilin Cancer Hospital

    132013ChangchunChina
  • Jinan Central Hospital

    105 Jie Fang Lu250013Jinan CityChina
  • Kangbuk Samsung Hospital

    03181SeoulKorea, Republic of
  • Kansai Medical University Hospital

    573-1191OsakaJapan
  • Kantonsspital Aarau

    5001AarauSwitzerland
  • Kantonsspital Graubünden Medizin Onkologie

    170 Loestrasse7000ChurSwitzerland
  • Kindai University Hospital

    589-8511OsakaJapan
  • Klinikum Chemnitz gGmbH

    2 Flemmingstraße09116ChemnitzGermany
  • Klinikum der Philipps-Universität Marburg

    35032MarburgGermany
  • Kosin University Gospel Hospital

    49267BusanKorea, Republic of
  • Kurume University Hospital

    830-0011FukuokaJapan
  • Kyungpook National University Chilgok Hospital

    41404DaeguKorea, Republic of
  • Kyushu University Hospital

    812-8582FukuokaJapan
  • Lakeridge Health Oshawa

    L1G 2B9OshawaCanada
  • Liv Hospital Ankara

    No:8 Bestekar Cd06680AnkaraTurkey
  • Maharaj Nakorn Chiang Mai Hospital

    110 Intrawarorot Road Soi 250200ChiangMaiThailand
  • Medeniyet University Goztepe Training and Research Hospital.

    34722kadikoeyTurkey
  • NHO Kinki Chuo Chest Medical Center

    591-8555OsakaJapan
  • Northwest Georgia Oncology Centers PC - Marietta

    340 Kennestone Hospital Blvd30060MariettaUnited States
  • Nottingham City Hospital

    NG5 1PBNottinghamUnited Kingdom
  • Odense Universitetshospital, Onkologisk Afdeling R

    4 J. B. Winsløws Vej5000Odense CDenmark
  • Oncocentro Belo Horizonte

    561 R. Roma30360-680Minas GeraisBrazil
  • Oncologico Potosino

    139 La Mora78209San Luis PotosíMexico
  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    618 Rua São Cristóvão98700-000IjuiBrazil
  • Osaka International Cancer Institute

    541-8567OsakaJapan
  • Palmerston North Hospital

    50 Ruahine St4442Palmerston NorthNew Zealand
  • PIH Health Whittier Hospital

    12401 Washington Blvd90602WhittierUnited States
  • Pingxiang People Hospital

    337000pingxiang-cityChina
  • Pramongkutklao Hospital

    315 Thanon Ratchawithi10400BangkokThailand
  • Prince of Wales Hospital

    ShatinHong Kong
  • Qingdao Central Hospital

    127 Si Liu Nan Lu266042qingdao-cityChina
  • Queen Mary Hospital

    Hong KongHong Kong
  • Rigshospitalet

    2100København ØDenmark
  • Royal Victoria Regional Health Centre

    201 Georgian DrL4M 6M2BarrieCanada
  • Saitama Cancer Center

    362-0806SaitamaJapan
  • Samsung Changwon Hospital

    51353Gyeongsangnam-doKorea, Republic of
  • Sault Area Hospital

    750 Great Northern RdP6B 0A8Sault Ste. MarieCanada
  • SCRI Florida Cancer Specialists North

    560 Jackson St N33705Saint PetersburgUnited States
  • SCRI Florida Cancer Specialists South

    12451 Gateway Blvd33901Fort MyersUnited States
  • Sendai Kousei Hospital

    981-0914MiyagiJapan
  • Seoul National University Hospital

    03080SeoulKorea, Republic of
  • Seoul St Mary's Hospital

    06591SeoulKorea, Republic of
  • Severance Hospital, Yonsei University Health System

    03722SeoulKorea, Republic of
  • Sichuan Cancer Hospital

    55 Ren Min Nan Lu Si Duan610041Chengdu CityChina
  • Sjællands Universitetshospital, Roskilde

    10 Sygehusvej4000RoskildeDenmark
  • Songklanagarind Hospital

    15 Kanjanavanich Rd90110SongkhlaThailand
  • St. Vincent's Hospital

    16247Gyeonggi-doKorea, Republic of
  • St. Vincentius Kliniken Karlsruhe

    32 Südendstraße76137KarlsruheGermany
  • Taipei Veterans General Hospital

    201號 Section 2, Shipai Rd11217Taipei CityTaiwan
  • Takarazuka City Hospital

    665-0827HyogoJapan
  • Tauranga Hospital, Clinical Trials Unit

    848 Cameron Rd3112TaurangaNew Zealand
  • Tennessee Oncology Chattanooga

    1032 McCallie Ave37403ChattanoogaUnited States
  • The Cancer Institute Hospital of JFCR

    135-8550TokyoJapan
  • The First Affiliated Hospital of Xian Jiao Tong University

    710061Xi'an CityChina
  • The First Affiliated Hospital of Xinxiang Medical University

    453000xinxiang-cityChina
  • The First Affiliated Hospital of Zhengzhou University

    1 Jian She Dong Lu450052Zhengzhou ShiChina
  • Torrance Memorial Physician Network/Cancer Care

    3285 Skypark Dr90505TorranceUnited States
  • Trakya University Medical Faculty

    22030EdirneTurkey
  • Tuen Mun Hospital

    23號 Tsing Chung Koon RdHong KongHong Kong
  • UCLA

    90095Los AngelesUnited States
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

    1 Langenbeckstraße55131MainzGermany
  • UniversitätsSpital Zürich

    8091ZürichSwitzerland
  • University Hospital Kyoto Prefectural University of Medicine

    602-8566KyotoJapan
  • Vajira Hospital

    681 Thanon Samsen10300BangkokThailand
  • Vitaz

    1 Moerlandstraat9100Sint-NiklaasBelgium
  • Wakayama Medical University Hospital

    641-8510WakayamaJapan
  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    78 Jagiellońska10-357OlsztynPoland
  • Weifang People's Hospital

    151 Guang Wen Jie261041weifang-cityChina
  • West China Hospital - Sichuan University

    37 Guo Xue Xiang610047Chengdu CityChina
  • Xiangya Hospital Central South University

    410008Changsha CityChina
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study Summary

    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).

    Hoffmann-La Roche Sponsor
    Phase 2/Phase 3 Phase
    NCT04619797, BO42592, 2022-502031-20-00 Study Identifier
    All Gender
    ≥18 Years Age
    No Healthy Volunteers

    1. Why is this study needed?

    Non-small cell lung cancer (NSCLC) is the most common type of lung cancer that usually develops in the tissues lining the lungs. Non-squamous NSCLC are commonly found towards the outer parts of the lungs. In advanced NSCLC, the cancer spreads to other parts of the body. Sometimes, NSCLC presents at a stage that cannot be removed surgically (unresectable). Cancer treatment often includes a combination of drugs. However, these may not work for all patients, or at all times. Therefore, there is always a need to find new combinations of treatments.

    This study is testing a combination of tiragolumab and atezolizumab. It is being developed as a combination treatment for NSCLC. Previous studies have shown that tiragolumab and atezolizumab can be given to treat advanced NSCLC. Atezolizumab alone or in combination with platinum-based cancer medicines (chemotherapy) are approved by health authorities for treating advanced NSCLC and other cancer types. However, in this study, the combination of tiragolumab and atezolizumab is considered to be experimental. Health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved the combination of tiragolumab and atezolizumab for the treatment of non-squamous NSCLC. Pemetrexed and pembrolizumab are approved medicines for the treatment of NSCLC.

    This study aims to compare the effects of tiragolumab plus atezolizumab with pemetrexed and chemotherapy versus placebo plus pembrolizumab and chemotherapy in people with non-squamous NSCLC. Placebo is a medicine without any active ingredients.

    2. Who could take part in the study?

    People who were at least 18 years old with advanced non-squamous NSCLC that could not be surgically removed and those who did not receive any prior treatment could take part in this study. People who were pregnant, or breastfeeding also could not participate in the study.

    3. How does this study work?

    People were screened to check if they were able to participate in the study. The screening period took place for about 28 days before the start of treatment.

    Everyone who joined this study was split into two groups (Groups A and B). They will receive either atezolizumab plus tiragolumab with pemetrexed and chemotherapy (Group A) or placebo plus pembrolizumab with pemetrexed and chemotherapy (Group B), as drip into the vein every 3 weeks. Treatment may continue up to 24 months or until the cancer worsens, or participants experience any unacceptable unwanted effects, or withdraw from the study, whichever occurs first. Since the main results of this study showed reduced benefit in Group A compared with Group B, participants receiving atezolizumab plus tiragolumab are recommended to stop the study treatment and take other cancer treatments outside of this study. Those receiving pembrolizumab and chemotherapy may continue receiving treatment as planned or discontinue from the study and seek treatment options outside of the study.

    This was a double-blinded study. This means that neither the participants in the study nor the team running it would know which treatment is being given until the study is over. However, the study is no longer blinded, and both the participants and researchers are aware of the treatment that participants received.

    During this study, the study doctor will meet the participants every 3 weeks to see how well the treatment is working and any unwanted effects participants may have. Total time of participation in the study will depend on how the cancer responds to treatment. Participants have the right to stop study treatment and leave the study at any time, if they wish to do so.

    4. What are the main results measured in this study?

    The main results measured in the study are to find out the number of participants whose cancer responded to the treatment. The approximate time from the start of treatment until the first occurrence of cancer worsening or participants dying due to any cause will also be measured. Other key results measured include:

    • Time taken for the cancer to come back in a participant who was previously cancer-free after undergoing treatment.
    • Change in participant’s physical health and quality of life over time
    • Number of participants with unwanted effects
    • How well the body processes tiragolumab and atezolizumab
    • Number of participants whose bodies produce proteins that work against tiragolumab and atezolizumab

    5. Are there any risks or benefits in taking part in this study?

    Taking part in the study may or may not make participants feel better. But the information collected in the study can help other people with similar health conditions in the future.

    The study results showed reduced benefit among participants treated with tiragolumab plus atezolizumab and chemotherapy compared with pembrolizumab plus chemotherapy. It may not be fully known at this time how safe the study treatment is. The study involves some risks to the participant. But these risks are generally not greater than those related to routine medical care or the natural progression of the health condition. People interested in taking part were informed about the risks and benefits, as well as any additional procedures or tests they may have to undergo. All details of the study were described in an informed consent document. This included information about possible effects and other options of treatment.

    Risks associated with the study drugs
    Participants may have unwanted effects of the drugs used in this study. These unwanted effects can be mild to severe, even life-threatening, and vary from person to person. During this study, participants are having regular check-ups to see if there are any unwanted effects.

    Tiragolumab
    Participants were told about the known unwanted effects of tiragolumab, and possible unwanted effects based on human and laboratory studies or knowledge of similar medicines. Known unwanted effects include inflammation of the liver (hepatitis) with symptoms of yellowing of the skin, pain in the stomach area, nausea, vomiting, itching, fatigue (feeling tired or weak), bleeding or bruising under the skin, and dark urine.
    Atezolizumab
    Participants were told about the known unwanted effects of atezolizumab, and possible unwanted effects based on human and laboratory studies or knowledge of similar medicines. Known unwanted effects include back pain, cough, decreased appetite, weakness, fever, headache, itching of the skin (pruritus), rash, joint pain (arthralgia), lack of energy (asthenia), and shortness of breath (dyspnea).
    Pembrolizumab
    Known unwanted effects include a decrease in red blood cells, white cells (neutrophils), and cells that help blood to clot (platelets), numbness, weakness, tingling or burning pain in arms and legs, feeling less hungry, trouble sleeping, muscle aches, and rash.

    Tiragolumab, atezolizumab, pemetrexed, pembrolizumab, chemotherapy, and placebo are given as a drip into a vein. Known unwanted effects with infusion include irritation where the injection is given, fever, chills, swelling, rash, redness, itching, or pain. The study medicines may be harmful to an unborn baby. Women and men must take precautions to avoid exposing an unborn baby to the study treatment.

    Study Summary

    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).

    Hoffmann-La Roche Sponsor
    Phase 2/Phase 3 Phase
    NCT04619797, BO42592, 2022-502031-20-00 Trial Identifier
    Tiragolumab, Atezolizumab, Pemetrexed, Carboplatin, Cisplatin, Tiragolumab Matching Placebo, Pembrolizumab Treatments
    Non-small Cell Lung Cancer (NSCLC) Condition
    Official Title

    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

    Eligibility Criteria

    All Gender
    ≥18 Years Age
    No Healthy Volunteers
    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.
    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.

    About Clinical Research

    What is a clinical trial? Why should I consider taking part in a clinical trial? And why does Genentech conduct clinical trials?

    Find out now