Back to resultsA Study of Atezolizumab With or Without Tiragolumab Consolidation in Limited Stage Small Cell Lung Cancer
Primary Purpose
Carcinoma, Small Cell Lung
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Atezolizumab
Tiragolumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Small Cell Lung
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent Form
- ECOG performance status of 0 or 1
- Histologically confirmed limited-stage SCLC.
- Patients who have not progressed during/after chemoradiotherapy.
- Concurrent or sequential chemoradiotherapy per local clinical practice must have been completed within 6 weeks prior to the first study treatment. If concurrent CRT is used, at least two cycles of chemotherapy should have been conducted during radiotherapy. If sequential radiotherapy is used, induction chemotherapy should be given 2 cycles of chemotherapy before thoracic radiotherapy.
- Adequate hematologic and end organ function.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the final dose of atezolizumab or placebo, and 90 days after the final dose of tiragolumab or placebo, and 6 months for chemotherapy after the last dose of chemotherapy treatment, whichever is later.
- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm.
- Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior therapy.
- Patients must submit a pre-treatment tumor tissue sample.
Exclusion Criteria:
- Histology mixtured or Extensive-stage SCLC (per the Veterans Administration Lung Study Group (VALG) staging system).
- Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease
- Malignancies other than SCLC within 5 years prior to study treatment initiation, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab and 90 days after the final dose of tiragolumab, and 6 months for chemotherapy after the final dose of the chemotherapy treatment.
- Active or history of autoimmune disease or immune deficiency
- Uncontrolled or symptomatic hypercalcemia
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Positive test result for HIV
- Patients with active hepatitis B or hepatitis C virus
- Active tuberculosis
- Severe infections within 4 weeks prior to study treatment initiation, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
- Significant cardiovascular disease
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA4, anti-tigit, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Unresolved toxic effects of grade 2 or higher (CTCAE 5.0), including grade ≥ 2 pneumonitis from previous therapy
- Active EBV infection or known or suspected chronic active EBV infection at screening.
Sites / Locations
- Beijing Cancer Hospital
- Jilin Cancer Hospital
- Hu Nan Provincial Cancer Hospital
- Sichuan Cancer Hospital
- Southwest Hospital , Third Military Medical University
- Fujian Cancer Hospital
- Sun Yet-sen University Cancer Center
- The First Affiliated Hospital of Guangzhou Medical University
- Harbin Medical University Cancer Hospital
- Anhui Province Cancer Hospital
- Shandong Cancer Hospital
- Guangxi Cancer Hospital of Guangxi Medical University
- Fudan University Shanghai Cancer Center; Medical Oncology
- Tianjin Cancer Hospital
- Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
- Henan Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A: Atezolizumab + Tiragolumab
Arm B: Atezolizumab + Placebo
Arm Description
Participants will receive atezolizumab + tiragolumab intravenously on the first day of each cycle. One cycle of therapy will be defined as 21 days. Atezolizumab and tiragolumab treatment will continue up to 17 doses unless investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).
Participants will receive atezolizumab + placebo on the first day of each cycle. One cycle of therapy will be defined as 21 days. Atezolizumab and placebo treatment will continue up to 17 doses unless investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).
Outcomes
Primary Outcome Measures
Investigator Assessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Secondary Outcome Measures
Overall Survival (OS) in the ITT Population
OS is defined as the time from randomization to death from any cause or last follow-up.
PFS Rate at 1 Year and 2 Years in the ITT Ppulation
PFS rate at 1 year and 2 years, defined as the proportion of patients remaining stable disease or ongoing response per RECIST v1.1 at 1 year and 2 years from the time of randomization.
OS Rate at 1 Year, 2 Years and 3 Years in the ITT Population
OS rate at 1 year, 2 years and 3 years is defined as the proportion of patients remaining alive 1 year, 2 years and 3 years from the time of randomization.
Objective Response Rate (ORR) in the ITT Population
ORR is defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1 in patients who have measurable disease at baseline.
Duration of Response (DOR) in the ITT Population
DOR is defined as the time interval from first occurrence of a documented objective response to the time of disease progression as determined by the investigator according to the RECIST v1.1 or death from any cause, whichever occurs first, in the patients who have experienced a CR or PR (unconfirmed) during the study.
Investigator Accessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population by Response to Chemoradiotherapy (CRT) [Stable Disease (SD) vs. Complete Response (CR)/Partial Response (PR)]
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Overall Survival (OS) in the ITT Population by Response to CRT (SD vs. CR/PR)
OS is defined as the time from randomization to death from any cause or last follow-up.
Objective Response Rate (ORR) in the ITT Population by Response to CRT (SD vs. CR/PR)
ORR is defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1.
Investigator Accessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population by Radiotherapy Timing (Concurrent vs. Sequential)
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Overall Survival (OS) in the ITT Population by Radiotherapy Timing (Concurrent vs. Sequential)
OS is defined as the time from randomization to death from any cause or last follow-up.
Objective Response Rate (ORR) in the ITT Population by Radiotherapy Timing (Concurrent vs. Sequential)
ORR is defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1.
Percentage of Participants With All Adverse Events Related to Atezolizumab and Atezolizumab + Tiragolumab Treatment in the ITT Population
Percentage of Participants With Serious and Non-Serious Immune Mediated Adverse Events Related to Atezolizumab and Atezolizumab + Tiragolumab Treatment in the ITT Population
Percentage of Participants With All Adverse Events Related to Treatment in the ITT Population
Time to Deterioration (TTD) in Patient-Rported Lung Cancer Symptoms
TTD is defined as the time from randomization to a patient's first ≥10-point score change from baseline in a scale maintained for at least two consecutive PRO assessments, or followed by death within 3 weeks of the first ≥10-point score change.
EORTC QLQ-C30 Score
EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 Questionnaire, is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales.
EORTC QLQ-LC13 Score
The EORTC, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, QLQ-LC13 is a modular supplement to the EORTC quality-of-life questionnaire for use in lung cancer. This module incorporates one multiple-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Based and Visual Analogue Scale (VAS) Scores
The EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L), is a validated self-report health status questionnaire that is used to calculate a health status utility score for use in health economic analyses. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analogue scale (VAS) that measures health state. Published weighting systems allow for creation of a single composite score of the patient's health status.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04308785
Brief Title
A Study of Atezolizumab With or Without Tiragolumab Consolidation in Limited Stage Small Cell Lung Cancer
Official Title
A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 2 Study to Investigate the Efficacy and Safety of Atezolizumab With or Without Tiragolumab as Consolidation Therapy in Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
The sponsor's decision was based on the negative results of SKYSCRAPER-02.
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy.
Detailed Description
Participants can receive concurrent or sequential chemoradiotherapy (CRT) as per local standard of care, but they must be randomized within 6 weeks from completion of chemoradiotherapy. Participants should receive 4 cycles of chemotherapy and radiotherapy dose of 56-64 Gy (once daily) before randomization, and those participants who have not progressed during/after CRT will be stratified by response to CRT, radiotherapy timing, and be randomized in a 1:1 ratio to Atezolizumab+Tiragolumab arm or Atezolizumab+placebo arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Atezolizumab + Tiragolumab
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab + tiragolumab intravenously on the first day of each cycle. One cycle of therapy will be defined as 21 days. Atezolizumab and tiragolumab treatment will continue up to 17 doses unless investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).
Arm Title
Arm B: Atezolizumab + Placebo
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab + placebo on the first day of each cycle. One cycle of therapy will be defined as 21 days. Atezolizumab and placebo treatment will continue up to 17 doses unless investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be administered at a dose of 1200 mg intravenously on the first day of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Intervention Description
Tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each 21-day cycle.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each cycle.
Primary Outcome Measure Information:
Title
Investigator Assessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population
Description
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Time Frame
Randomization up to approximately 48 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in the ITT Population
Description
OS is defined as the time from randomization to death from any cause or last follow-up.
Time Frame
Randomization up to approximately 48 months
Title
PFS Rate at 1 Year and 2 Years in the ITT Ppulation
Description
PFS rate at 1 year and 2 years, defined as the proportion of patients remaining stable disease or ongoing response per RECIST v1.1 at 1 year and 2 years from the time of randomization.
Time Frame
Baseline to 1 Year and 2 Years
Title
OS Rate at 1 Year, 2 Years and 3 Years in the ITT Population
Description
OS rate at 1 year, 2 years and 3 years is defined as the proportion of patients remaining alive 1 year, 2 years and 3 years from the time of randomization.
Time Frame
Baseline to 1 Year, 2 Years and 3 Years
Title
Objective Response Rate (ORR) in the ITT Population
Description
ORR is defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1 in patients who have measurable disease at baseline.
Time Frame
Randomization up to approximately 48 months
Title
Duration of Response (DOR) in the ITT Population
Description
DOR is defined as the time interval from first occurrence of a documented objective response to the time of disease progression as determined by the investigator according to the RECIST v1.1 or death from any cause, whichever occurs first, in the patients who have experienced a CR or PR (unconfirmed) during the study.
Time Frame
Time from first documentation of complete response (CR) or partial response (PR) up to approximately 48 months
Title
Investigator Accessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population by Response to Chemoradiotherapy (CRT) [Stable Disease (SD) vs. Complete Response (CR)/Partial Response (PR)]
Description
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Time Frame
Randomization up to approximately 33 months
Title
Overall Survival (OS) in the ITT Population by Response to CRT (SD vs. CR/PR)
Description
OS is defined as the time from randomization to death from any cause or last follow-up.
Time Frame
Randomization up to approximately 48 months
Title
Objective Response Rate (ORR) in the ITT Population by Response to CRT (SD vs. CR/PR)
Description
ORR is defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1.
Time Frame
Randomization up to approximately 48 months
Title
Investigator Accessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population by Radiotherapy Timing (Concurrent vs. Sequential)
Description
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.
Time Frame
Randomization up to approximately 48 months
Title
Overall Survival (OS) in the ITT Population by Radiotherapy Timing (Concurrent vs. Sequential)
Description
OS is defined as the time from randomization to death from any cause or last follow-up.
Time Frame
Randomization up to approximately 48 months
Title
Objective Response Rate (ORR) in the ITT Population by Radiotherapy Timing (Concurrent vs. Sequential)
Description
ORR is defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1.
Time Frame
Randomization up to approximately 48 months
Title
Percentage of Participants With All Adverse Events Related to Atezolizumab and Atezolizumab + Tiragolumab Treatment in the ITT Population
Time Frame
Baseline up to approximately 48 months
Title
Percentage of Participants With Serious and Non-Serious Immune Mediated Adverse Events Related to Atezolizumab and Atezolizumab + Tiragolumab Treatment in the ITT Population
Time Frame
Baseline up to approximately 48 months
Title
Percentage of Participants With All Adverse Events Related to Treatment in the ITT Population
Time Frame
Baseline up to approximately 48 months
Title
Time to Deterioration (TTD) in Patient-Rported Lung Cancer Symptoms
Description
TTD is defined as the time from randomization to a patient's first ≥10-point score change from baseline in a scale maintained for at least two consecutive PRO assessments, or followed by death within 3 weeks of the first ≥10-point score change.
Time Frame
Randomization up to approximately 48 months
Title
EORTC QLQ-C30 Score
Description
EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 Questionnaire, is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales.
Time Frame
Day 1 of first 3 cycles (each cycle is 21 days) then with tumor assessments & 3 months after radiographic disease progression or for patients who continue atezolizumab after radiographic disease progression loss of clinical benefit up to approx 48 months
Title
EORTC QLQ-LC13 Score
Description
The EORTC, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, QLQ-LC13 is a modular supplement to the EORTC quality-of-life questionnaire for use in lung cancer. This module incorporates one multiple-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
Time Frame
Day 1 of first 3 cycles (cycle length=21 days), then with tumor assessments & 3 months after radiographic disease progression or for patients who continue atezolizumab after radiographic disease progression loss of clinical benefit up to approx 48 months
Title
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Based and Visual Analogue Scale (VAS) Scores
Description
The EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L), is a validated self-report health status questionnaire that is used to calculate a health status utility score for use in health economic analyses. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analogue scale (VAS) that measures health state. Published weighting systems allow for creation of a single composite score of the patient's health status.
Time Frame
Day 1 of first 3 cycles (each cycle is 21 days) then with tumor assessments & 3 months after radiographic disease progression or for patients who continue atezolizumab after radiographic disease progression loss of clinical benefit up to approx 48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent Form
ECOG performance status of 0 or 1
Histologically confirmed limited-stage SCLC.
Patients who have not progressed during/after chemoradiotherapy.
Concurrent or sequential chemoradiotherapy per local clinical practice must have been completed within 6 weeks prior to the first study treatment. If concurrent CRT is used, at least two cycles of chemotherapy should have been conducted during radiotherapy. If sequential radiotherapy is used, induction chemotherapy should be given 2 cycles of chemotherapy before thoracic radiotherapy.
Adequate hematologic and end organ function.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the final dose of atezolizumab or placebo, and 90 days after the final dose of tiragolumab or placebo, and 6 months for chemotherapy after the last dose of chemotherapy treatment, whichever is later.
For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm.
Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior therapy.
Patients must submit a pre-treatment tumor tissue sample.
Exclusion Criteria:
Histology mixtured or Extensive-stage SCLC (per the Veterans Administration Lung Study Group (VALG) staging system).
Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures
Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease
Malignancies other than SCLC within 5 years prior to study treatment initiation, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab and 90 days after the final dose of tiragolumab, and 6 months for chemotherapy after the final dose of the chemotherapy treatment.
Active or history of autoimmune disease or immune deficiency
Uncontrolled or symptomatic hypercalcemia
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
Positive test result for HIV
Patients with active hepatitis B or hepatitis C virus
Active tuberculosis
Severe infections within 4 weeks prior to study treatment initiation, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Significant cardiovascular disease
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA4, anti-tigit, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Unresolved toxic effects of grade 2 or higher (CTCAE 5.0), including grade ≥ 2 pneumonitis from previous therapy
Active EBV infection or known or suspected chronic active EBV infection at screening.
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
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Facility Name
Hu Nan Provincial Cancer Hospital
City
Changsha
ZIP/Postal Code
410006
Country
China
Facility Name
Sichuan Cancer Hospital
City
Chengdu City
ZIP/Postal Code
610041
Country
China
Facility Name
Southwest Hospital , Third Military Medical University
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Anhui Province Cancer Hospital
City
Hefei City
ZIP/Postal Code
230031
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Facility Name
Guangxi Cancer Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Fudan University Shanghai Cancer Center; Medical Oncology
City
Shanghai City
ZIP/Postal Code
201315
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430023
Country
China
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
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.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 Sharing of Clinical Study 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
A Study of Atezolizumab With or Without Tiragolumab Consolidation in Limited Stage Small Cell Lung Cancer
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