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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03563716
Recruitment Status : Active, not recruiting
First Posted : June 20, 2018
Results First Posted : July 9, 2020
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE June 20, 2018
Results First Submitted Date  ICMJE June 19, 2020
Results First Posted Date  ICMJE July 9, 2020
Last Update Posted Date June 1, 2022
Actual Study Start Date  ICMJE August 10, 2018
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • 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) ]
    ORR, 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: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
  • Progression Free Survival (PFS) [ Time Frame: From baseline until a total of 80 PFS events have occurred (up to approximately 11 months) ]
    PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2018)
  • Objective response rate (ORR) [ Time Frame: Up to 5 years ]
    ORR, defined as a complete response or partial response on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1
  • Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
    PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
  • Duration of Objective Response (DOR) [ Time Frame: Up to 5 years ]
    DOR, defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).
  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
    OS, defined as the time from randomization to death from any cause.
  • Percentage of Participants With Adverse Events [ Time Frame: Up to 5 years ]
    An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
  • Serum Concentrations of Tiragolumab [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). ]
  • Serum Concentrations of Atezolizumab [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). ]
  • Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2018)
  • Duration of Objective Response (DOR) [ Time Frame: Up to 5 years ]
    DOR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first
  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
    OS, defined as the time from randomization to death from any cause
  • Percentage of Participants With Adverse Events [ Time Frame: Up to 5 years ]
  • Serum concentrations of MTIG7192A or atezolizumab [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). ]
  • Perecentage of treatment-emergent anti-drug antibody-positive participants and anti-drug antibody-negative participants [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Atezolizumab
    Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.
    Other Name: Tecentriq
  • Drug: Tiragolumab
    Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
    Other Name: MTIG7192A
  • Drug: Placebo
    Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Study Arms  ICMJE
  • Placebo Comparator: Placebo + Atezolizumab
    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.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Placebo
  • Experimental: Tiragolumab + Atezolizumab
    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.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Tiragolumab
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 7, 2019)
135
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2018)
120
Estimated Study Completion Date  ICMJE October 31, 2022
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Korea, Republic of,   Serbia,   Spain,   Taiwan,   United States
Removed Location Countries Brazil,   Poland,   Romania
 
Administrative Information
NCT Number  ICMJE NCT03563716
Other Study ID Numbers  ICMJE GO40290
2018-000280-81 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Genentech, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Genentech, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP