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Non-small Cell Lung CancerPhase 2NCT03563716

A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase 2 study testing Atezolizumab and Tiragolumab in people with Non-small Cell Lung Cancer, run by Genentech, Inc. at 40 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Atezolizumab and Tiragolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
40 sitesin 6 countries
Study dates
10 Aug 2018to 14 Nov 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

40 sites in 6 countries.

40 sites in 6 countries

United States11 sites

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida, 33901

  • Research Medical Center

    Kansas City, Missouri, 64132

  • SCRI Tennessee Oncology

    Nashville, Tennessee, 37203

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Florida Cancer Specialists - NORTH - SCRI - PPDS

    St. Petersburg, Florida, 33705

  • Arizona Oncology Associates, PC - HAL

    Tempe, Arizona, 85284

  • Northwest Cancer Specialists - Vancouver

    Vancouver, Washington, 98684

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

Other trials in United States

Spain10 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Univ Germans Trias i Pujol

    Badalona, Barcelona, 8916

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

  • Complejo Hospitalario Universitario Insular?Materno Infantil

    Las Palmas de Gran Canaria, LAS Palmas, 35016

  • Clinica Universitaria Navarra (Madrid)

    Madrid, 28036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29010

  • Centro Medico Quironsalud Sagrado Corazon

    Seville, 41013

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

South Korea6 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

France5 sites

  • ICO Paul Papin

    Angers, 49055

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

    Bordeaux, 33076

  • Centre Georges François Leclerc

    Dijon, 21079

  • Hopital Nord AP-HM

    Marseille, 13015

  • Institut De Cancerologie De L'Ouest

    Saint-Herblain, 44115

Other trials in France

Taiwan5 sites

  • Taipei Medical University ?Shuang Ho Hospital

    New Taipei City, 23561

  • National Cheng Kung University Hospital

    North Dist., 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 1121

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan, 333

Other trials in Taiwan

Serbia3 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11070

  • Institute of Lung Diseases Vojvodina

    Kamenitz, Južnobanatski Okrug, 21204

Other trials in Serbia

About this study

Official title: A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.

Being tested
Atezolizumab, Tiragolumab, Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.

  • TiragolumabDrug

    Also called MTIG7192A

    Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

  • PlaceboDrug

    Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Study groups in NCT03563716
Study groupRoleWhat they receive
Placebo + AtezolizumabPlacebo comparatorParticipants will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Receives: Drug: Atezolizumab; Drug: Placebo
Tiragolumab + AtezolizumabExperimentalParticipants will receive atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Receives: Drug: Atezolizumab; Drug: Tiragolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.

    Measured: From baseline until a total of 80 progression-free survival (PFS) events have occurred (up to approximately 11 months)

  2. Progression-free Survival (PFS)

    PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. Kaplan-Meier (KM) methodology was used to estimate the median PFS.

    Measured: From baseline until a total of 80 PFS events have occurred (up to approximately 11 months)

Secondary outcomes (7)

  1. Duration of Objective Response (DOR)

    DOR was defined as the time from the first occurrence of a documented objective response (OR) (CR or PR) to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. KM methodology was used to estimate the median DOR.

    Measured: Up to approximately 36 months

  2. Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.

    Measured: Up to approximately 36 months

  3. Number of Participants With Adverse Events (AEs)

    An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measured: From initiation of study drug up to approximately 83.7 months

  4. Minimum Serum Concentration (Cmin) of Tiragolumab

    Measured: Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days)

  5. Cmin of Atezolizumab

    Measured: Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days)

  6. Number of Participants With Treatment-Emergent Anti-drug Antibodies (ADAs) to Tiragolumab

    Participants who received tiragolumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following tiragolumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.

    Measured: Up to approximately 36 months

  7. Number of Participants With Treatment-Emergent ADAs to Atezolizumab

    Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.

    Measured: Up to approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start10 Aug 2018
  3. Primary completion30 Jun 2019
  4. Study completion14 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03563716
Sponsor's protocol ID
GO40290
Other IDs
2018-000280-81, 2023-508083-30-00, 2023, 2018
Status last verified
Apr 2026
First submitted
17 Apr 2018
Last updated
4 May 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Guan X, Hu R, Choi Y, Srivats S, Nabet BY, Silva J, McGinnis L, Hendricks R, Nutsch K, Banta KL, Duong E, Dunkle A, Chang PS, Han CJ, Mittman S, Molden N, Daggumati P, Connolly W, Johnson M, Abreu DR, Cho BC, Italiano A, Gil-Bazo I, Felip E, Mellman I, Mariathasan S, Shames DS, Meng R, Chiang EY, Johnston RJ, Patil NS. Anti-TIGIT antibody improves PD-L1 blockade through myeloid and Treg cells. Nature. 2024 Mar;627(8004):646-655. doi: 10.1038/s41586-024-07121-9. Epub 2024 Feb 28.

    PubMed 38418879

  • Cho BC, Abreu DR, Hussein M, Cobo M, Patel AJ, Secen N, Lee KH, Massuti B, Hiret S, Yang JCH, Barlesi F, Lee DH, Ares LP, Hsieh RW, Patil NS, Twomey P, Yang X, Meng R, Johnson ML. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022 Jun;23(6):781-792. doi: 10.1016/S1470-2045(22)00226-1. Epub 2022 May 13.

    PubMed 35576957

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab and Tiragolumab in people with Non-small Cell Lung Cancer, run by Genentech, Inc. at 40 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Spain, South Korea, France, Taiwan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From baseline until a total of 80 progression-free survival (PFS) events have occurred (up to approximately 11 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03563716, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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