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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02366143
Registration number
NCT02366143
Ethics application status
Date submitted
12/02/2015
Date registered
19/02/2015
Date last updated
23/09/2021
Titles & IDs
Public title
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
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Secondary ID [1]
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2014-003207-30
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Secondary ID [2]
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GO29436
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Universal Trial Number (UTN)
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Trial acronym
IMpower150
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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Lung - Non 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 - Bevacizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Experimental: Arm A (Atezolizumab+Paclitaxel+Carboplatin) - Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Experimental: Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) - Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Active comparator: Arm C (Bevacizumab+Paclitaxel+Carboplatin) - Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Treatment: Drugs: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.
Treatment: Drugs: Bevacizumab
Bevacizumab was administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, or death.
Treatment: Drugs: Carboplatin
Carboplatin was administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Treatment: Drugs: Paclitaxel
Paclitaxel was administered as IV infusion at a dose of 200 milligrams per square meter (mg/m\^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
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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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Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population
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Assessment method [1]
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Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.
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Timepoint [1]
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Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)
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Primary outcome [2]
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Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
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Assessment method [2]
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Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
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Timepoint [2]
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Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)
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Primary outcome [3]
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Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
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Assessment method [3]
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Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
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Timepoint [3]
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Baseline until death (up approximately 53 months)
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Secondary outcome [1]
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PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population
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Assessment method [1]
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PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.
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Timepoint [1]
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Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
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Secondary outcome [2]
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PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population
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Assessment method [2]
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PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population.
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Timepoint [2]
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Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
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Secondary outcome [3]
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PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
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Assessment method [3]
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PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population.
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Timepoint [3]
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Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
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Secondary outcome [4]
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PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup
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Assessment method [4]
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PFS as Determined by the Investigator according to RECIST v1.1, in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)
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Timepoint [4]
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Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
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Secondary outcome [5]
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OS in Arm B Versus Arm C by PD-L1 Subgroup
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Assessment method [5]
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OS in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)
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Timepoint [5]
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Baseline until death (up to approximately 34 months)
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Secondary outcome [6]
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OS in Arm A Versus Arm C by PD-L1 Subgroup
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Assessment method [6]
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OS in Arm A Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)
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Timepoint [6]
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Baseline until death (up approximately 53 months)
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Secondary outcome [7]
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OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
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Assessment method [7]
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Timepoint [7]
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Baseline until death (up to approximately 34 months)
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Secondary outcome [8]
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OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
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Assessment method [8]
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Timepoint [8]
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Baseline until death (up approximately 53 months)
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Secondary outcome [9]
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OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
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Assessment method [9]
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Timepoint [9]
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Baseline until death (up approximately 53 months)
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Secondary outcome [10]
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Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C
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Assessment method [10]
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DOR, as determined by investigator according to RECIST v1.1 in Arm B versus Arm C in the Teff high-WT population and the ITT-WT population.
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Timepoint [10]
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Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
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Secondary outcome [11]
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Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator in the Teff-High-WT Population and ITT-WT Population
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Assessment method [11]
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Percentage of Participants With an Objective Response (OR) (Complete Response \[CR\] or Partial Response \[PR\]) as Determined by the Investigator using RECIST v1.1 in the Teff-High-WT population and ITT-WT population.
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Timepoint [11]
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Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
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Secondary outcome [12]
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OS Rates at Years 1 and 2 in Arm B Versus Arm C
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Assessment method [12]
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OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.
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Timepoint [12]
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Baseline to 2 years or death, whichever occurs first.
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Secondary outcome [13]
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OS Rates at Years 1 and 2 in Arm A Versus Arm C
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Assessment method [13]
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OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.
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Timepoint [13]
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Baseline to 2 years or death, whichever occurs first.
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Secondary outcome [14]
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Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
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Assessment method [14]
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EORTC QLQ-C30 is a validated \& reliable self-report measure (Aaronson et al.1993;Fitzsimmons et al.1999) that consists of 30 questions that assess 5 aspects of patient functioning (physical,emotional,role, cognitive,and social), 3 symptom scales (fatigue,nausea \& vomiting, pain),global health/quality of life,and six single items (dyspnea,insomnia, appetite loss,constipation,diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life);however a high score for a symptom scale or item represents a high level of symptomatology or problems. A =10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al.1998).
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Timepoint [14]
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Baseline up to approximately 29 months
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Secondary outcome [15]
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TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
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Assessment method [15]
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QLQ-LC13 Quality-of-Life Questionnaire Lung Cancer 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. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A =10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
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Timepoint [15]
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Baseline up to approximately 29 months
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Secondary outcome [16]
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Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
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Assessment method [16]
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The SILC (Symptoms in Lung Cancer) scale was used to assess patient-reported severity of lung cancer symptoms (chest pain, dyspnea, and cough). The SILC scale is a 9-item content validated self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a symptom severity score. The SILC questionnaire comprises three individual symptoms (dyspnea, cough, chest pain) and are scored at the individual symptom level, thus have a dyspnea score, chest pain score, and cough score. Each individual symptom score is calculated as the average of responses for the symptom items \[e.g. Chest Pain Score=mean (item 1; item 2)\]. An increase in score is suggestive of a worsening in symptomology (i.e. frequency or severity). A score change of =0.3 points for the dyspnea and cough symptom scores is considered to be clinically significant; whereas a score change of =0.5 points for the chest pain score is considered to be clinically significant.
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Timepoint [16]
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Baseline up to approximately 29 months
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Secondary outcome [17]
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Percentage of Participants With Adverse Events
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Assessment method [17]
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Percentage of participants with at least one adverse event.
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Timepoint [17]
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Baseline up to data cutoff date 7 December 2020 (up to approximately 68 months)
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Secondary outcome [18]
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Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
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Assessment method [18]
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Timepoint [18]
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Baseline up to approximately 29 months
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Secondary outcome [19]
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Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B
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Assessment method [19]
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The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
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Timepoint [19]
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Day 1 of Cycle 1 and 3 (Cycle length=21 days)
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Secondary outcome [20]
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Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
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Assessment method [20]
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Timepoint [20]
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Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days)
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Secondary outcome [21]
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Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
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Assessment method [21]
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Timepoint [21]
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Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (Cycle length=21 days)
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Secondary outcome [22]
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Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
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Assessment method [22]
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Timepoint [22]
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Predose (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (Cycle length=21 days)
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Secondary outcome [23]
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Cmax of Bevacizumab in Arm B and Arm C
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Assessment method [23]
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Timepoint [23]
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Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days)
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Secondary outcome [24]
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Cmin of Bevacizumab in Arm B and Arm C
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Assessment method [24]
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Timepoint [24]
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Cycle 1 Day 1 and Cycle 2 Day 21 (Cycle length=21 days)
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Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group performance status 0 or 1
* Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
* Participants with no prior treatment for Stage IV non-squamous NSCLC
* Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and end organ function
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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
Cancer-Specific Exclusions:
* Active or untreated central nervous system metastases
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
General Medical Exclusions:
* 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 computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Positive test for human immunodeficiency virus
* Active hepatitis B or hepatitis C
* Severe infection within 4 weeks prior to randomization
* Significant cardiovascular disease
* Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures
Exclusion Criteria Related to Medications:
* Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
31/03/2015
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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
7/12/2020
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Sample size
Target
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Accrual to date
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Final
1202
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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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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Concord Repatriation General Hospital - Concord
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Recruitment hospital [3]
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Nepean Cancer Care Centre - Sydney
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Recruitment hospital [4]
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Prince Charles Hospital; Department of Medical Oncology - Chermside
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Recruitment hospital [5]
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Townsville Hospital - Townsville
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [7]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [8]
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Adelaide Cancer Centre - Kurralta Park
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Recruitment hospital [9]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [10]
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Launceston General Hospital - Launceston
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Recruitment hospital [11]
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Frankston Hospital - Frankston
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Recruitment hospital [12]
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Austin Health - Heidelberg
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Recruitment hospital [13]
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Cabrini Hospital Malvern - Malvern
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Recruitment hospital [14]
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The Alfred Hospital - Prahan
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Sunshine Hospital - St Albans
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Recruitment hospital [16]
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Sir Charles Gairdner Hospital - Nedlands
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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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2139 - Concord
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Recruitment postcode(s) [3]
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2747 - Sydney
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Recruitment postcode(s) [4]
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4032 - Chermside
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Recruitment postcode(s) [5]
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4810 - Townsville
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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5037 - Kurralta Park
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Recruitment postcode(s) [9]
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7000 - Hobart
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Recruitment postcode(s) [10]
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7250 - Launceston
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Recruitment postcode(s) [11]
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3199 - Frankston
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Recruitment postcode(s) [12]
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3084 - Heidelberg
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Recruitment postcode(s) [13]
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3144 - Malvern
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Recruitment postcode(s) [14]
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3181 - Prahan
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Recruitment postcode(s) [15]
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3021 - St Albans
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Recruitment postcode(s) [16]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Illinois
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Maine
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Maryland
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North Carolina
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West Virginia
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Argentina
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Buenos Aires
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Funding & Sponsors
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Commercial sector/industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).
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Trial website
https://clinicaltrials.gov/study/NCT02366143
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Trial related presentations / publications
Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471. Nogami N, Barlesi F, Socinski MA, Reck M, Thomas CA, Cappuzzo F, Mok TSK, Finley G, Aerts JG, Orlandi F, Moro-Sibilot D, Jotte RM, Stroyakovskiy D, Villaruz LC, Rodriguez-Abreu D, Wan-Teck Lim D, Merritt D, Coleman S, Lee A, Shankar G, Yu W, Bara I, Nishio M. IMpower150 Final Exploratory Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in Key NSCLC Patient Subgroups With EGFR Mutations or Metastases in the Liver or Brain. J Thorac Oncol. 2022 Feb;17(2):309-323. doi: 10.1016/j.jtho.2021.09.014. Epub 2021 Oct 7. Socinski MA, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kong S, Lee A, Coleman S, Zou W, McCleland M, Shankar G, Reck M. IMpower150 Final Overall Survival Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC. J Thorac Oncol. 2021 Nov;16(11):1909-1924. doi: 10.1016/j.jtho.2021.07.009. Epub 2021 Jul 24. Reck M, Wehler T, Orlandi F, Nogami N, Barone C, Moro-Sibilot D, Shtivelband M, Gonzalez Larriba JL, Rothenstein J, Fruh M, Yu W, Deng Y, Coleman S, Shankar G, Patel H, Kelsch C, Lee A, Piault E, Socinski MA. Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Aug 1;38(22):2530-2542. doi: 10.1200/JCO.19.03158. Epub 2020 May 27. Reck M, Mok TSK, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Lee A, Coleman S, Deng Y, Kowanetz M, Shankar G, Lin W, Socinski MA; IMpower150 Study Group. Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respir Med. 2019 May;7(5):387-401. doi: 10.1016/S2213-2600(19)30084-0. Epub 2019 Mar 25. Socinski MA, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kelsch C, Lee A, Coleman S, Deng Y, Shen Y, Kowanetz M, Lopez-Chavez A, Sandler A, Reck M; IMpower150 Study Group. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med. 2018 Jun 14;378(24):2288-2301. doi: 10.1056/NEJMoa1716948. Epub 2018 Jun 4.
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Public notes
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Contacts
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Hoffmann-La Roche
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/43/NCT02366143/Prot_001.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/43/NCT02366143/SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02366143
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