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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02763579
Registration number
NCT02763579
Ethics application status
Date submitted
4/05/2016
Date registered
5/05/2016
Date last updated
28/07/2023
Titles & IDs
Public title
A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
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Scientific title
A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
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Secondary ID [1]
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2015-004861-97
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Secondary ID [2]
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GO30081
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Universal Trial Number (UTN)
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Trial acronym
IMpower133
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Carcinoma
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Condition category
Condition code
Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Placebo
Experimental: Atezolizumab + Carboplatin + Etoposide - Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Active Comparator: Placebo + Carboplatin + Etoposide - Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Treatment: Drugs: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab intravenous infusion was administered at a dose of 1200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
Treatment: Drugs: Carboplatin
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
Treatment: Drugs: Etoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
Treatment: Drugs: Placebo
Placebo intravenous infusion was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
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Assessment method [1]
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Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).
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Timepoint [1]
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Baseline until PD or death, whichever occurs first (up to approximately 23 months)
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Primary outcome [2]
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Duration of Overall Survival (OS) in the Global Population
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Assessment method [2]
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OS is defined as the time from randomization to death from any cause.
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Timepoint [2]
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Baseline until death from any cause (up to approximately 23 months)
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Secondary outcome [1]
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Percentage of Participants With Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
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Assessment method [1]
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Objective response (OR) is defined as complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1.
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Timepoint [1]
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Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 23 months)
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Secondary outcome [2]
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Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
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Assessment method [2]
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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 using RECIST v1.1 or death from any cause, whichever comes first.
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Timepoint [2]
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First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 23 months)
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Secondary outcome [3]
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PFS Rate at 6 Months and at 1 Year in Global Population
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Assessment method [3]
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PFS rates at 6 months and at 1 year is defined as the proportion of participants who are alive without disease progression 6 months and 1 year after randomization, respectively.
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Timepoint [3]
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6 months, 1 year
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Secondary outcome [4]
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OS Rate at 1 Year and 2 Years in the Global Population
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Assessment method [4]
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OS rates at 1 and 2 years is defined as the proportion of participants who are alive 1 year and 2 years after randomization, respectively.
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Timepoint [4]
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1 year, 2 years
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Secondary outcome [5]
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Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
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Assessment method [5]
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TTD according to the EORTC QLQ-C30 and EORTC QLQ-LC13 measures were evaluated in each of the following linearly transformed symptom scores: cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain. The linear transformation gives each individual symptom subscale a possible score of 0 to 100. For the symptom to be considered "deteriorated," a score increase of =10 points above baseline must be held for at least two consecutive assessments or an initial score increase of =10 points is followed by death within 3 weeks from the last assessment. A = 10-point change in the symptoms subscale score is perceived by participants as clinically significant.
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Timepoint [5]
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Baseline until deterioration per symptom subscale (up to approximately 23 months)
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Secondary outcome [6]
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Percentage of Participants With at Least One Adverse Event in the Global Population
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Assessment method [6]
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The percentage of participants with at least one adverse event in the global population.
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Timepoint [6]
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Baseline until up to 90 days after end of treatment (up to approximately 49 months)
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Secondary outcome [7]
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Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab in the Global Population
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Assessment method [7]
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The baseline prevalence and post-baseline incidence of ADAs against atezolizumab.
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Timepoint [7]
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Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 23 months) and 120 days after last dose (up to approximately 23 months overall)
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Secondary outcome [8]
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Maximum Observed Serum Concentration (Cmax) of Atezolizumab in the Global Population
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Assessment method [8]
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Atezolizumab maximum observed plasma concentration (Cmax; 30 minutes following the end of the atezolizumab infusion) for each respective day.
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Timepoint [8]
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Post-dose Day 1 of Cycle 1 (cycle length = 21 days)
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Secondary outcome [9]
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Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
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Assessment method [9]
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Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.
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Timepoint [9]
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Predose on Day 1 of Cycles 1, 3, 4, 8, 16 and 24 (cycle length = 21 days)
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Secondary outcome [10]
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Plasma Concentration of Carboplatin in the Global Population
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Assessment method [10]
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Plasma concentration of carboplatin in the Global population.
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Timepoint [10]
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Predose, before end of infusion, and after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)
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Secondary outcome [11]
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Plasma Concentration of Etoposide in the Global Population
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Assessment method [11]
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Plasma concentration of etoposide in the Global Population.
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Timepoint [11]
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Predose, before end of infusion, 1 and 4 hours after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)
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Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration
Lung Study Group [VALG] staging system)
- No prior systemic treatment for ES-SCLC
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function
- Treatment-free for at least 6 months since last chemo/radiotherapy, among those
treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Active or untreated central nervous system (CNS) metastases as determined by computed
tomography (CT) or magnetic resonance imaging (MRI) evaluation
- Malignancies other than SCLC within 5 years prior to randomization, with the exception
of those with a negligible risk of metastasis or death treated with expected curative
outcome
- Pregnant or lactating women
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is
permitted.
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Severe infections at the time of randomization
- Significant cardiovascular disease
- Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint
blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic
antibody
- History of severe (or known) hypersensitivity to chimeric or humanized antibodies or
fusion proteins or any component of atezolizumab formulation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/06/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/07/2022
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Sample size
Target
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Accrual to date
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Final
503
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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The Prince Charles Hospital; Oncology Dept. - Chermside
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Recruitment hospital [3]
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Royal Melbourne Hospital; Hematology and Medical Oncology - Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4032 - Chermside
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment outside Australia
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Taoyuan
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Exeter
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
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Summary
Brief summary
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was
designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1
[PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment
with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.
Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin +
etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the
induction phase followed by maintenance with atezolizumab or placebo until progressive
disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid
Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD
or symptomatic deterioration.
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https://clinicaltrials.gov/ct2/show/NCT02763579
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02763579
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