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New drug duo shows promise against lung cancer in early trial

NCT ID NCT03563716

Disease control Sponsor: Genentech, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tested whether adding tiragolumab to the standard immunotherapy atezolizumab helps people with advanced non-small cell lung cancer who have not had chemotherapy. 135 participants received either the combination or a placebo plus atezolizumab. The main goals were to see if tumors shrank and how long they stayed under control.

What this could mean

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

Active substance
Tiragolumab and atezolizumab (immunotherapy drugs)
What this could lead to
If successful, this combination could offer a new first-line immunotherapy option for people with advanced non-small cell lung cancer, potentially shrinking tumors and delaying disease progression.
What could go wrong
This is a phase 2 trial with only 135 participants, so results are preliminary. The combination may not prove more effective than existing treatments, and immune-related side effects are possible.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

135 people

The number who actually took part.

Started

Aug 2018

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.

Inclusion Criteria: * ECOG Performance Status of 0 or 1 * Histologically or cytologically documented locally advanced unresectable NSCLC, recurrent, or metastatic NSCLC of either squamous or non-squamous histology * No prior systemic treatment for locally advanced unresectable or metastatic NSCLC * Tumor PD-L1 expression * Measurable disease, as defined by RECIST v1.1 * Life expectancy \>=12 weeks * Adequate hematologic and end-organ function * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria: Cancer-Specific Exclusions: * Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Spinal cord compression not definitively treated with surgery and/or radiation, and/or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to screening * History of leptomeningeal disease * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Uncontrolled tumor-related pain * Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome General Medical Exclusions: * Pregnant and lactating women * Significant cardiovascular disease * Severe infections within 4 weeks prior to randomization * Major surgical procedure other than for diagnosis within 4 weeks prior to randomization Treatment-Specific Exclusions: * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation * History of autoimmune disease * Prior allogeneic bone marrow transplantation or solid organ transplantation * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or active tuberculosis * Administration of a live, attenuated vaccine within 4 weeks prior to randomization

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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

Contacts and locations

Locations

  • Arizona Oncology Associates, PC - HAL

    Tempe, Arizona, 85284, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Centre Georges François Leclerc

    Dijon, 21079, France

  • Centro Medico Quironsalud Sagrado Corazon

    Seville, 41013, Spain

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan, 333, Taiwan

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Clinica Universitaria Navarra (Madrid)

    Madrid, 28036, Spain

  • Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11070, Serbia

  • Complejo Hospitalario Universitario Insular?Materno Infantil

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

  • Florida Cancer Specialists - NORTH - SCRI - PPDS

    St. Petersburg, Florida, 33705, United States

  • Hopital Nord AP-HM

    Marseille, 13015, France

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29010, Spain

  • Hospital Univ Germans Trias i Pujol

    Badalona, Barcelona, 8916, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • ICO Paul Papin

    Angers, 49055, France

  • Illinois Cancer Care

    Peoria, Illinois, 61615, United States

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005, United States

  • Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

    Bordeaux, 33076, France

  • Institut De Cancerologie De L'Ouest

    Saint-Herblain, 44115, France

  • Institute of Lung Diseases Vojvodina

    Kamenitz, Južnobanatski Okrug, 21204, Serbia

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • National Cheng Kung University Hospital

    North Dist., 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Northwest Cancer Specialists - Vancouver

    Vancouver, Washington, 98684, United States

  • Research Medical Center

    Kansas City, Missouri, 64132, United States

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida, 33901, United States

  • SCRI Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Taipei Medical University ?Shuang Ho Hospital

    New Taipei City, 23561, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 1121, Taiwan

  • University of Kansas Medical Center

    Westwood, Kansas, 66205, United States

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

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