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SKYSCRAPER-02C: Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04665856
Collaborator
(none)
123
Enrollment
16
Locations
2
Arms
51.7
Anticipated Duration (Months)
7.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this multicenter study in China is to evaluate the safety and efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with untreated extensive-stage small cell lung cancer.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
123 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Actual Study Start Date :
Dec 22, 2020
Anticipated Primary Completion Date :
Apr 27, 2023
Anticipated Study Completion Date :
Apr 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tiragolumab + Atezolizumab + Carboplatin and Etoposide

Induction treatment with tiragolumab plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab plus atezolizumab for 21-day cycles.

Drug: Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Other Names:
  • MTIG7192A

    • Drug: Atezolizumab
    Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
    Other Names:
  • Tecentriq

    • Drug: Carboplatin
    Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.

    Drug: Etoposide
    Etoposide 100 mg/m^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.
    Placebo Comparator: Placebo + Atezolizumab + Carboplatin and Etoposide

    Induction treatment with placebo plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo plus atezolizumab for 21-day cycles

    Drug: Atezolizumab
    Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
    Other Names:
  • Tecentriq

    • Drug: Carboplatin
    Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.

    Drug: Etoposide
    Etoposide 100 mg/m^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.

    Drug: Tiragolumab Matching Placebo
    Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

    Outcome Measures

    Primary Outcome Measures

    1. Investigator-Assessed Progression-Free Survival (PFS) in the Primary Population [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 46 months)]

    2. Overall Survival (OS) in the Primary Population [From randomization to death from any cause (up to approximately 46 months)]

    Secondary Outcome Measures

    1. PFS in the Intent-To-Treat (ITT) Population [From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 46 months)]

    2. OS in the ITT Population [From randomization to death from any cause (up to approximately 46 months)]

    3. Investigator-Assessed Confirmed Objective Response Rate (ORR) in the Primary Population [From randomization up to approximately 46 months]

    4. Investigator-Assessed Confirmed ORR in the ITT Population [From randomization up to approximately 46 months]

    5. Investigator-Assessed Duration of Response (DOR) in the Primary Population [From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 46 months)]

    6. Investigator-Assessed DOR in the ITT Population [From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 46 months)]

    7. Investigator-Assessed PFS Rates at 6 Months and 12 Months in the Primary Population [Month 6, Month 12]

    8. Investigator-Assessed PFS Rates at 6 Months and 12 Months in the ITT Population [Month 6, Month 12]

    9. Overall Survival Rates at 12 Months and 24 Months in the Primary Population [Month 12, Month 24]

    10. Overall Survival Rates at 12 Months and 24 Months in the ITT Population [Month 12, Month 24]

    11. Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the Primary Population [Up to approximately 46 months]

    12. TTCD Assessed Using EORTC QLQ-C30 Score in the ITT Population [Up to approximately 46 months]

    13. Percentage of Participants with Adverse Events, Determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) [Up to approximately 46 months]

    14. Serum Concentration of Tiragolumab at Specified Timepoints [Cycle 1 (each cycle=21 days), Day 1: predose, 0.5 hour (h) postdose; Cycles 2, 3, 4, 8, 12, 16, Day 1: predose and at treatment discontinuation (TD) visit (up to approximately 46 months)]

    15. Serum Concentration of Atezolizumab at Specified Timepoints [Cycle 1 (each cycle=21 days), Day 1: predose, 0.5 hour (h) postdose; Cycles 2, 3, 4, 8, 12, 16, Day 1: predose and at TD visit (up to approximately 46 months)]

    16. Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab [Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 46 months)]

    17. Percentage of Participants With ADAs to Atezolizumab [Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 46 months)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

    • Histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the modified Veterans Administration Lung Study Group (VALG) staging system

    • No prior systemic treatment for ES-SCLC

    • For participants who have received prior chemoradiotherapy for limited-stage SCLC must have had treatment with curative intent and a treatment-free interval of at least 6 months between the last dose/cycle of chemotherapy, thoracic radiotherapy, or chemoradiotherapy and the diagnosis of ES-SCLC

    • Measurable diseases as defined by RECIST v1.1

    • Submission of a pre-treatment tumor tissue sample

    • Adequate hematologic and end-organ function

    • Participants not receiving therapeutic anticoagulation with International Normalized Ratio (INR) and Activated Clotting Time (aPTT) </= 1.5 x ULN

    • Participants receiving therapeutic anticoagulation: stable anticoagulant regimen

    • Negative Human Immunodeficiency Virus (HIV) test at screening

    • Negative hepatitis B surface antigen (HBsAg) test at screening

    • Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) and/or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test

    • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test

    • Negative Epstein-Barr virus (EBV) viral capsid antigen (VCA) IgM test or negative EBV polymerase chain reaction (PCR) test at screening

    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs

    • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.

    Exclusion Criteria:

    • Symptomatic or actively progressing central nervous system (CNS) metastases

    • Spinal cord compression

    • Leptomeningeal disease

    • Uncontrolled pleural effusion, pericardial effusion, or ascites

    • Uncontrolled or symptomatic hypercalcemia

    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse

    • Malignancies other than SCLC within 5 years prior to randomization

    • Active or history of autoimmune disease or immune deficiencies

    • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computer Tomography (CT) scan

    • Known active tuberculosis, Current treatment with anti-viral therapy for HBV or HCV

    • Severe chronic or active infection

    • Treatment with therapeutic oral or IV antibiotics

    • Significant cardiovascular disease

    • Major surgical procedure other than for diagnosis

    • Prior allogeneic bone marrow transplantation or solid organ transplant

    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition

    • Administration of a live, attenuated vaccine

    • Prior treatment with CD137 agonists, T-cell co-stimulating, or immune checkpoint blockade therapies

    • Treatment with systemic immunostimulatory agents

    • Treatment with systemic immunosuppressive medications

    • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

    • Known hypersensitivity to Chinese Hamster Ovary (CHO) cell products or to any component of the tiragolumab or atezolizumab formulations

    • History of allergic reactions to carboplatin or etoposide

    • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or within 90 days after the final dose of tiragolumab or for 6 months after the final dose of carboplatin or etoposide.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Cancer Hospital Beijing China 100142
    2 Beijing Chest Hospital; Oncology Department Beijing China 101149
    3 the First Affiliated Hospital of Bengbu Medical College Bengbu City China 233000
    4 the First Hospital of Jilin University Changchun China 130021
    5 Fujian Provincial Cancer Hospital Fuzhou City China 350014
    6 Cancer Center of Guangzhou Medical University Guangzhou China 510000
    7 Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department Hangzhou City China 310022
    8 Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Hangzhou China 310016
    9 Harbin Medical University Cancer Hospital Harbin China 150081
    10 The 1st Affiliated Hospital of Nanchang Unversity Nanchang China 330019
    11 Fudan University Shanghai Cancer Center Shanghai City China 200120
    12 Shanghai Chest Hospital Shanghai China 200000
    13 Zhongshan Hospital Fudan University Shanghai China 200032
    14 Cancer Hospital of Shantou University Medical College Shantou China 515041
    15 Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology Wuhan City China 430022
    16 Henan Cancer Hospital Zhengzhou China 450008

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04665856
    Other Study ID Numbers:
    • YO42373
    First Posted:
    Dec 14, 2020
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Small Cell Lung Carcinoma
    Carboplatin
    Etoposide
    Atezolizumab

    Study Results

    No Results Posted as of Aug 16, 2022