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

Primary Purpose

Small Cell Lung Carcinoma

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tiragolumab
Atezolizumab
Carboplatin
Etoposide
Tiragolumab Matching Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Cancer Hospital
  • Beijing Chest Hospital; Oncology Department
  • the First Affiliated Hospital of Bengbu Medical College
  • the First Hospital of Jilin University
  • Fujian Provincial Cancer Hospital
  • Cancer Center of Guangzhou Medical University
  • Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
  • Harbin Medical University Cancer Hospital
  • The 1st Affiliated Hospital of Nanchang Unversity
  • Fudan University Shanghai Cancer Center
  • Shanghai Chest Hospital
  • Zhongshan Hospital Fudan University
  • Cancer Hospital of Shantou University Medical College
  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
  • Henan Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tiragolumab + Atezolizumab + Carboplatin and Etoposide

Placebo + Atezolizumab + Carboplatin and Etoposide

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set (PAS)
Overall Survival (OS) in the PAS

Secondary Outcome Measures

PFS in the Full Analysis Set (FAS)
OS in the FAS
Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS
Investigator-Assessed Confirmed ORR in the FAS
Investigator-Assessed Duration of Response (DOR) in the PAS
Investigator-Assessed DOR in the FAS
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS
Overall Survival Rates at 12 Months and 24 Months in the PAS
Overall Survival Rates at 12 Months and 24 Months in the FAS
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 PAS
TTCD Assessed Using EORTC QLQ-C30 Score in the FAS
Percentage of Participants with Adverse Events, Determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)
Serum Concentration of Tiragolumab at Specified Timepoints
Serum Concentration of Atezolizumab at Specified Timepoints
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab

Full Information

First Posted
December 7, 2020
Last Updated
September 28, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04665856
Brief Title
Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
Acronym
SKYSCRAPER-02C
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tiragolumab + Atezolizumab + Carboplatin and Etoposide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + Atezolizumab + Carboplatin and Etoposide
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Other Intervention Name(s)
MTIG7192A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide 100 mg/m^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab Matching Placebo
Intervention Description
Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set (PAS)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 49 months)
Title
Overall Survival (OS) in the PAS
Time Frame
From randomization to death from any cause (up to approximately 49 months)
Secondary Outcome Measure Information:
Title
PFS in the Full Analysis Set (FAS)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 49 months)
Title
OS in the FAS
Time Frame
From randomization to death from any cause (up to approximately 49 months)
Title
Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS
Time Frame
From randomization up to approximately 49 months
Title
Investigator-Assessed Confirmed ORR in the FAS
Time Frame
From randomization up to approximately 49 months
Title
Investigator-Assessed Duration of Response (DOR) in the PAS
Time Frame
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 49 months)
Title
Investigator-Assessed DOR in the FAS
Time Frame
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 49 months)
Title
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS
Time Frame
Month 6, Month 12
Title
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS
Time Frame
Month 6, Month 12
Title
Overall Survival Rates at 12 Months and 24 Months in the PAS
Time Frame
Month 12, Month 24
Title
Overall Survival Rates at 12 Months and 24 Months in the FAS
Time Frame
Month 12, Month 24
Title
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 PAS
Time Frame
Up to approximately 49 months
Title
TTCD Assessed Using EORTC QLQ-C30 Score in the FAS
Time Frame
Up to approximately 49 months
Title
Percentage of Participants with Adverse Events, Determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)
Time Frame
Up to approximately 49 months
Title
Serum Concentration of Tiragolumab at Specified Timepoints
Time Frame
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 49 months)
Title
Serum Concentration of Atezolizumab at Specified Timepoints
Time Frame
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 49 months)
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Time Frame
Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 49 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Chest Hospital; Oncology Department
City
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
the First Affiliated Hospital of Bengbu Medical College
City
Bengbu City
ZIP/Postal Code
233000
Country
China
Facility Name
the First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou City
ZIP/Postal Code
350014
Country
China
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
City
Hangzhou City
ZIP/Postal Code
310022
Country
China
Facility Name
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
The 1st Affiliated Hospital of Nanchang Unversity
City
Nanchang
ZIP/Postal Code
330019
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
ZIP/Postal Code
515041
Country
China
Facility Name
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430022
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). 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).

Learn more about this trial

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

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