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New drug cocktail aims to outperform current lung cancer therapy

NCT ID NCT04619797

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether adding the experimental immunotherapy tiragolumab to a standard combination of atezolizumab and chemotherapy works better than the current standard treatment (pembrolizumab plus chemotherapy) for people with advanced non-squamous non-small cell lung cancer who had not received prior treatment. About 542 participants were randomly assigned to one of two treatment arms. The goal was to see if the new combo could delay cancer growth or improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tiragolumab (an immunotherapy drug) combined with atezolizumab (Tecentriq) and chemotherapy (pemetrexed plus carboplatin or cisplatin)
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with advanced non-squamous lung cancer, potentially improving how long they live without their cancer growing.
What could go wrong
This is a completed trial, but results may not show a significant benefit over the current standard treatment. Immunotherapy combinations can cause serious immune-related side effects. The findings may not apply to all lung cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

542 people

The number who actually took part.

Started

Dec 2020

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer (NSCLC)

Contacts and locations

Locations

  • A.O. Villa Scassi

    Genoa, Liguria, 16149, Italy

  • ARKE Estudios Clínicos S.A. de C.V.

    Mexico City, 06700, Mexico

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300, Belgium

  • Adana Baskent University Medical Faculty

    Adana, 01220, Turkey (Türkiye)

  • Advent Health Orlando

    Winter Park, Florida, 32789, United States

  • Affiliated Hospital of Chengde Medical University

    Chengde, 067020, China

  • Anhui Provincial Hospital

    Hefei, 230088, China

  • Ankara Bilkent City Hospital

    Ankara, 06490, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023, New Zealand

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50139, Italy

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Barts & London School of Med

    London, EC1A 7BE, United Kingdom

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • CHU Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091, France

  • CHU UCL Mont-Godinne

    Mont-godinne, 5530, Belgium

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, 31100, France

  • Castle Hill Hospital

    Hull, HU16 5JQ, United Kingdom

  • Centro Di Riferimento Oncologico

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

    Lódz, 90-338, Poland

  • Changhua Christian Hospital

    Chang-hua, 500, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Christie Hospital Nhs Trust

    Manchester, M2O 4BX, United Kingdom

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • Cliniques Universitaires St-Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, 15006, Spain

  • Complejo Hospitalario Universitario Insular?Materno Infantil

    Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-550, Brazil

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Cuidados oncologicos

    Querétaro City, Querétaro, 76000, Mexico

  • Dicle University Faculty of Medicine

    Diyarbakır, 21280, Turkey (Türkiye)

  • Faculty of Med. Siriraj Hosp.

    Bangkok, 10700, Thailand

  • Fort Wayne Medical Oncology and Hematology, Inc

    Fort Wayne, Indiana, 46804, United States

  • Guy'S Hospital

    London, SE1 9RT, United Kingdom

  • Helios Klinikum Emil von Behring GmbH

    Berlin, 14165, Germany

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hong Kong United Oncology Centre

    Hong Kong, Hong Kong

  • Hopital Nord

    Marseille, 13915, France

  • Hopital de Pontchaillou

    Rennes, 35033, France

  • Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Lucus Augusti

    Lugo, 27003, Spain

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198, Spain

  • Hospital Univ. Nuestra Señora de Valme

    Seville, 41014, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hubei Cancer Hospital

    Wuhan, 430079, China

  • ICO L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Institut Bergonie

    Bordeaux, 33076, France

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34000, Turkey (Türkiye)

  • Jilin Cancer Hospital

    Changchun, 132013, China

  • Jinan Central Hospital

    Jinan, 250013, China

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kansai Medical University Hospital

    Osaka, 573-1191, Japan

  • Kantonsspital Aarau

    Aarau, 5001, Switzerland

  • Kantonsspital Graubünden Medizin Onkologie

    Chur, 7000, Switzerland

  • Kindai University Hospital

    Osaka, 589-8511, Japan

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116, Germany

  • Klinikum der Philipps-Universität Marburg

    Marburg, 35032, Germany

  • Kosin University Gospel Hospital

    Busan, 49267, South Korea

  • Kurume University Hospital

    Fukuoka, 830-0011, Japan

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9, Canada

  • Liv Hospital Ankara

    Ankara, 06680, Turkey (Türkiye)

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200, Thailand

  • Medeniyet University Goztepe Training and Research Hospital.

    Kadiköy, 34722, Turkey (Türkiye)

  • NHO Kinki Chuo Chest Medical Center

    Osaka, 591-8555, Japan

  • New Cross Hospital

    Wolverhampton, WV10 0QP, United Kingdom

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060, United States

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000, Denmark

  • Oncocentro Belo Horizonte

    Belo Horizonte, Minas Gerais, 30360-680, Brazil

  • Oncologico Potosino

    San Luis Potosí City, San Luis Potosí, 78209, Mexico

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • PIH Health Whittier Hospital

    Whittier, California, 90602, United States

  • Palmerston North Hospital

    Palmerston North, 4442, New Zealand

  • Pingxiang People's Hospital

    Pingxiang, 337000, China

  • Prince of Wales Hospital

    Shatin, Hong Kong

  • Qingdao Central Hospital

    Qingdao, 266042, China

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Rigshospitalet

    København Ø, 2100, Denmark

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2, Canada

  • SCRI Florida Cancer Specialists North

    St. Petersburg, Florida, 33705, United States

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida, 33901, United States

  • Saitama Cancer Center

    Saitama, 362-0806, Japan

  • Samsung Changwon Hospital

    Gyeongsangnam-do, 51353, South Korea

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B 0A8, Canada

  • Sendai Kousei Hospital

    Miyagi, 981-0914, Japan

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Seoul St Mary's Hospital

    Seoul, 06591, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Sichuan Cancer Hospital

    Chengdu, 610041, China

  • Sjællands Universitetshospital, Roskilde

    Roskilde, 4000, Denmark

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • St. Vincent's Hospital

    Gyeonggi-do, 16247, South Korea

  • St. Vincentius Kliniken Karlsruhe

    Karlsruhe, 76137, Germany

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Takarazuka City Hospital

    Hyōgo, 665-0827, Japan

  • Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37403, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an, 710061, China

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, 453000, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052, China

  • Trakya University Medical Faculty

    Edirne, 22030, Turkey (Türkiye)

  • Tuen Mun Hospital

    Hong Kong, Hong Kong

  • UCLA

    Los Angeles, California, 90095, United States

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • UniversitätsSpital Zürich

    Zurich, 8091, Switzerland

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

    Mainz, 55131, Germany

  • Vajira Hospital

    Bangkok, 10300, Thailand

  • Vitaz

    Sint-Niklaas, 9100, Belgium

  • Waikato Hospital - Cancer and Blood Research Trials Unit

    Hamilton, 3204, New Zealand

  • Wakayama Medical University Hospital

    Wakayama, 641-8510, Japan

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357, Poland

  • Weifang People's Hospital

    Weifang, 261041, China

  • West China Hospital - Sichuan University

    Chengdu, 610047, China

  • Xiangya Hospital Central South University

    Changsha, 410008, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.