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

NCT03563716 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: GO402902018-000280-812023-508083-30-00
• Study Type: interventional
• Target: 135
• Locations: 6 countries
• Sites: 40

Brief 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 translocation.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (7)

• Duration of Objective Response (DOR)

  Up to approximately 36 months

• Overall Survival (OS)

  Up to approximately 36 months

• Number of Participants With Adverse Events (AEs)

  From initiation of study drug up to approximately 83.7 months

• Minimum Serum Concentration (Cmin) of Tiragolumab

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

• Cmin of Atezolizumab

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

Study Arms (2)

Placebo + Atezolizumab

PLACEBO COMPARATOR

Participants 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.

Drug: Atezolizumab; Drug: Placebo

Tiragolumab + Atezolizumab

EXPERIMENTAL

Participants 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.

Drug: Atezolizumab; Drug: Tiragolumab

Interventions

Tiragolumab DRUG

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

Also known as: MTIG7192A

Tiragolumab + Atezolizumab

Placebo DRUG

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

Placebo + Atezolizumab

Atezolizumab DRUG

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

Also known as: Tecentriq

Placebo + Atezolizumab; Tiragolumab + Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (40)

Arizona Oncology Associates, PC - HAL

Tempe, Arizona, 85284, United States

Location

SCRI Florida Cancer Specialists South

Fort Myers, Florida, 33901, United States

Location

Florida Cancer Specialists - NORTH - SCRI - PPDS

St. Petersburg, Florida, 33705, United States

Location

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

University of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

SCRI Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Northwest Cancer Specialists - Vancouver

Vancouver, Washington, 98684, United States

Location

ICO Paul Papin

Angers, 49055, France

Location

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

Bordeaux, 33076, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Hopital Nord AP-HM

Marseille, 13015, France

Location

Institut De Cancerologie De L'Ouest

Saint-Herblain, 44115, France

Location

Institute of Lung Diseases Vojvodina

Kamenitz, Južnobanatski Okrug, 21204, Serbia

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11070, Serbia

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hospital Univ Germans Trias i Pujol

Badalona, Barcelona, 8916, Spain

Location

Complejo Hospitalario Universitario Insular?Materno Infantil

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

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

Location

Clinica Universitaria Navarra (Madrid)

Madrid, 28036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, 28222, Spain

Location

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, 29010, Spain

Location

Centro Medico Quironsalud Sagrado Corazon

Seville, 41013, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Taipei Medical University ?Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

National Cheng Kung University Hospital

North Dist., 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 1121, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan, 333, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 38418879 DERIVED

• 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.

  PMID: 35576957 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab; Tiragolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: June 20, 2018
• Study Start: August 10, 2018
• Primary Completion: June 30, 2019
• Study Completion: November 14, 2025
• Last Updated: May 4, 2026
• Results First Posted: July 9, 2020

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

SE (3); US (11); FR (5); KR (6); ES (10); TW (5)