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A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer (SKYSCRAPER-01)

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ClinicalTrials.gov Identifier: NCT04294810
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected NSCLC, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be in a randomized 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab Drug: Tiragolumab Other: Matching Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : August 25, 2022
Estimated Study Completion Date : February 21, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tiragolumab + Atezolizumab
Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Drug: Atezolizumab
Atezolizumab 1200 mg administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Other Name: Tecentriq

Drug: Tiragolumab
Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Name: MTIG7192A

Placebo Comparator: Placebo + Atezolizumab
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
Drug: Atezolizumab
Atezolizumab 1200 mg administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Other Name: Tecentriq

Other: Matching Placebo
Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: From randomization up to disease progression or relapse or death (whichever occurs first), up to 59 months ]
  2. Overall Survival (OS) [ Time Frame: From randomization up to death of any cause, up to 59 months ]

Secondary Outcome Measures :
  1. Confirmed Overall Response Rate (ORR) [ Time Frame: From randomization up to disease progression or relapse or death (whichever occurs first), up to 59 months ]
  2. Duration of Response (DOR) [ Time Frame: From randomization up to disease progression or relapse or death (whichever occurs first), up to 59 months ]
  3. PFS Rates at 6 Months and 12 Months [ Time Frame: 6 months, 12 months ]
  4. OS Rates at 12 Months and 24 Months [ Time Frame: 12 months, 24 months ]
  5. Time to Sustained Deterioration (TTSD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score [ Time Frame: Up to 59 months ]
    TTSD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and quality of life (QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.

  6. PFS in Participants With Programmed Death-Ligand 1 (PD-L1) Expression [ Time Frame: From randomization up to disease progression or relapse or death (whichever occurs first), up to 59 months ]
  7. OS in Participants With PD-L1 Expression [ Time Frame: From randomization up to death of any cause, up to 59 months ]
  8. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to 59 months ]
  9. Minimum Serum Concentration (Cmin) of Tiragolumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at treatment discontinuation (TD) visit (up to 59 months) ]
  10. Maximum Serum Concentration (Cmax) of Tiragolumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 59 months) ]
  11. Cmin of Atezolizumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 59 months) ]
  12. Cmax of Atezolizumab [ Time Frame: Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 59 months) ]
  13. Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab [ Time Frame: Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8,12 and 16 and at TD visit (up to 59 months) ]
  14. Percentage of Participants With ADAs to Atezolizumab [ Time Frame: Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8,12 and 16 and at TD visit (up to 59 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC
  • No prior systemic treatment for metastatic NSCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay
  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  • Adequate hematologic and end-organ function

Exclusion Criteria:

  • Known mutation in the EGFR gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
  • Symptomatic, untreated, or actively progressing central nervous system 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
  • Malignancies other than NSCLC within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • Severe infection within 4 weeks prior to initiation of study treatment
  • Positive test result for human immunodeficiency virus (HIV)
  • Active hepatitis B or hepatitis C
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-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 prior to initiation of study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294810


Contacts
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Contact: Reference Study ID Number: GO41717 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
Show Show 151 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trial Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04294810    
Other Study ID Numbers: GO41717
2019-002925-31 ( EudraCT Number )
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Atezolizumab
Antineoplastic Agents