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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/NCT02367794
Registration number
NCT02367794
Ethics application status
Date submitted
13/02/2015
Date registered
20/02/2015
Date last updated
21/03/2022
Titles & IDs
Public title
A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
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Scientific title
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
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Secondary ID [1]
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2014-003208-59
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Secondary ID [2]
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GO29437
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Squamous Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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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-programmed death-ligand 1 (anti-PD-L1) antibody
Treatment: Drugs - Carboplatin
Treatment: Drugs - Nab-Paclitaxel
Treatment: Drugs - Paclitaxel
Experimental: Arm A: Atezolizumab + Paclitaxel + Carboplatin - The induction phase of the study will consist of four or six cycles; atezolizumab, paclitaxel, and carboplatin will be administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.
Experimental: Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin - The induction phase of the study will consist of four or six cycles; atezolizumab and carboplatin will be administered on Day 1 of each 21-day cycle. Nab-Paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.
Active Comparator: Arm C: Nab-Paclitaxel + Carboplatin - The induction phase of the study will consist of four or six cycles; carboplatin will be administered on Day 1 of each 21-day cycle, nab-paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: nab-paclitaxel, then carboplatin. Participants who experience disease progression at any time during the induction phase will discontinue all study treatment. In the maintenance phase, participants will receive best supportive care.
Treatment: Drugs: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody
Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.
Treatment: Drugs: Carboplatin
Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.
Treatment: Drugs: Nab-Paclitaxel
Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.
Treatment: Drugs: Paclitaxel
Paclitaxel 200 mg/m^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m^2 IV.
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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 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
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Assessment method [1]
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PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population.
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Timepoint [1]
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Up to approximately 30 months after first participant enrolled
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Primary outcome [2]
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Overall Survival (OS) in the ITT Population
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Assessment method [2]
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OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
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Timepoint [2]
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Up to approximately 39 months after first participant enrolled
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Secondary outcome [1]
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OS in the in the Teff Population
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Assessment method [1]
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OS is defined as the time between the date of randomization and date of death from any cause in the in the Teff Population.
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Timepoint [1]
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Up to approximately 39 months after first participant enrolled
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Secondary outcome [2]
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PFS as Determined by the Investigator Using RECIST v1.1 in the Teff Population
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Assessment method [2]
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PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Teff Population.
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Timepoint [2]
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Up to approximately 30 months after first participant enrolled
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Secondary outcome [3]
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PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population
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Assessment method [3]
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PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population.
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Timepoint [3]
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Up to approximately 30 months after first participant enrolled
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Secondary outcome [4]
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PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population
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Assessment method [4]
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PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the TC1/2/3 or IC1/2/3 Population.
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Timepoint [4]
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Up to approximately 30 months after first participant enrolled
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Secondary outcome [5]
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OS in the TC2/3 or IC2/3 Population
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Assessment method [5]
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OS is defined as the time between the date of randomization and date of death from any cause, in the TC2/3 or IC2/3 Population.
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Timepoint [5]
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Up to approximately 39 months after first participant enrolled
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Secondary outcome [6]
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OS in the TC1/2/3 or IC1/2/3 Population
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Assessment method [6]
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OS is defined as the time between the date of randomization and date of death from any cause in the TC1/2/3 or IC1/2/3 Population.
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Timepoint [6]
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Up to approximately 39 months after first participant enrolled
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Secondary outcome [7]
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Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population
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Assessment method [7]
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Proportion of participants with an objective response (CR or PR) in the ITT population.
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Timepoint [7]
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Up to approximately 30 months after first participant enrolled
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Secondary outcome [8]
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Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population
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Assessment method [8]
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Duration of response is defined as the time from the first documented objective response to documented PD or death from any cause, whichever occurred first, in the ITT Population.
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Timepoint [8]
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Up to approximately 30 months after first participant enrolled
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Secondary outcome [9]
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Event Free Rate at 1 and 2 Years in the ITT Population
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Assessment method [9]
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Event free rate at 1 and 2 years is defined as the proportion of participants alive at 1 and 2 years after randomization estimated using Kaplan-Meier (KM) methodology for the ITT population.
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Timepoint [9]
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1 and 2 years
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Secondary outcome [10]
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Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population
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Assessment method [10]
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TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population. The EORTC QLQ-C30 is a validated and reliable self-report measure that 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). EORTC scales and single-item measures will be linearly transformed so that each score has a range of 0-100. A high score for a functional scale represents a high or healthy level of functioning, and a high score for the global health status and HRQoL represents a high HRQoL; however, a high score for a symptom scale or item represents a high level of symptomatology or problems.
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Timepoint [10]
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Up to approximately 30 months after first participant enrolled
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Secondary outcome [11]
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TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population
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Assessment method [11]
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TTD was documented for a 3-symptom composite endpoint using the following EORTC QLQ-LC13 symptom scores: cough, chest pain, and dyspnea multi--item scale. In this instance, symptom deterioration will be determined as a >= 10-point increase above baseline in any of the listed symptom scores, whichever occurs first (cough, chest pain, and dyspnea multi-item scale). Confirmed clinically meaningful symptom deterioration will need to be held for the original symptom; a >= 10-point increase above baseline in a symptom score must be held for at least two consecutive assessments or an initial>=10-point increase above baseline followed by death within 3 weeks from the last assessment. A >= 10-point change in the EORTC scale score is perceived by patients as clinically significant.
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Timepoint [11]
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Up to approximately 30 months after the first participant enrolled
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Secondary outcome [12]
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Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population
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Assessment method [12]
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Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of =0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of =0.5 points for chest pain score is considered to be clinically significant. (Note: PD=progression of disease)
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Timepoint [12]
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Baseline up to approximately 30 months after first participant enrolled
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Secondary outcome [13]
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PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A and Arm B)
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Assessment method [13]
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PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT Population Arm A and Arm B.
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Timepoint [13]
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Up to approximately 30 months after first participant enrolled
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Secondary outcome [14]
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OS in the ITT Population (Arm A and Arm B)
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Assessment method [14]
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OS is defined as the time between the date of randomization and date of death from any cause in the ITT Population, Arm A and Arm B.
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Timepoint [14]
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Up to approximately 39 months after first participant enrolled
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Secondary outcome [15]
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Percentage of Participants With Adverse Events
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Assessment method [15]
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Percentage of participants with at least one adverse event.
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Timepoint [15]
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Up to approximately 68 months after first participant enrolled
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Secondary outcome [16]
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Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab
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Assessment method [16]
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Percentage of participants with Anti-therapeutic Antibody (ATA) response to atezolizumab.
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Timepoint [16]
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Up to approximately 30 months after first participant enrolled
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Secondary outcome [17]
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Maximum Observed Serum Atezolizumab Concentration (Cmax)
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Assessment method [17]
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Maximum observed serum atezolizumab concentration (Cmax). 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 [17]
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Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)
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Secondary outcome [18]
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Minimum Observed Serum Atezolizumab Concentration (Cmin)
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Assessment method [18]
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Minimum observed serum atezolizumab concentration (Cmin). The predose samples will be collected on the same day of treatment administration.
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Timepoint [18]
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Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 30 months), at treatment discontinuation (up to 30 months), and at 120 days after the last dose of atezolizumab (up to approximately 30 months, each cycle is 21 days)
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Secondary outcome [19]
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Plasma Concentrations for Paclitaxel
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Assessment method [19]
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Plasma concentrations for paclitaxel.
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Timepoint [19]
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Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 180 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
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Secondary outcome [20]
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Plasma Concentrations for Nab-Paclitaxel
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Assessment method [20]
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Plasma concentrations for nab-paclitaxel.
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Timepoint [20]
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Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
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Secondary outcome [21]
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Plasma Concentrations for Carboplatin
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Assessment method [21]
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Plasma concentrations for carboplatin.
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Timepoint [21]
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Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 15 to 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
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Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
- Previously obtained archival tumor tissue or tissue obtained from 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
- Active or untreated central nervous system (CNS) metastasis
- 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
- 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 (CT) scan, History of radiation pneumonitis in the radiation
field (fibrosis) is permitted
- Positive test for Human Immunodeficiency Virus (HIV)
- Active hepatitis B or hepatitis C
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1
therapeutic antibody
- Severe infection within 4 weeks prior to randomization
- Significant history of cardiovascular disease
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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
11/06/2015
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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
17/02/2021
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Sample size
Target
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Accrual to date
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Final
1021
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,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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Calvary Mater Newcastle; Medical Oncology - Waratah
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Prince Charles Hospital - Chermside
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Townsville Hospital - Townsville
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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Austin Health - Heidelberg
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Cabrini Hospital Malvern - Malvern
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Recruitment hospital [9]
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Sunshine Hospital - St Albans
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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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2298 - Waratah
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Recruitment postcode(s) [3]
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4032 - Chermside
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Recruitment postcode(s) [4]
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4810 - Townsville
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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3084 - Heidelberg
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Recruitment postcode(s) [8]
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3144 - Malvern
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Recruitment postcode(s) [9]
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3021 - St Albans
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Recruitment postcode(s) [10]
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6009 - Nedlands
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Recruitment outside Australia
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Salzburg
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Ronse
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiago
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Chile
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Temuco
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France
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Grenoble
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France
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Le Mans
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France
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Lyon
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France
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Montpellier
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France
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Orleans
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Country [57]
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France
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Pierre Benite
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Country [58]
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France
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Rennes
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Country [59]
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France
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Saint Pierre
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Country [60]
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France
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Saint Quentin
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Country [61]
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France
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Toulon Cedex 9
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Country [62]
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Germany
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Berlin
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Germany
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Bielefeld
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Country [64]
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Germany
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Bochum
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Country [65]
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Germany
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Dresden
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Country [66]
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Germany
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Frankfurt am Main
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Country [67]
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Germany
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State/province [67]
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Gerlingen
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Country [68]
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Germany
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Großhansdorf
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Country [69]
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Germany
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Halle
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Country [70]
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Germany
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Hamburg
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Country [71]
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Germany
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Hemer
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Country [72]
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Germany
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Homburg
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Country [73]
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Germany
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Immenhausen
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Country [74]
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Germany
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Koln
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Country [75]
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Germany
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Minden
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Country [76]
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Germany
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State/province [76]
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München
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Country [77]
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Germany
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Regensburg
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Country [78]
0
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Germany
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State/province [78]
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Rheine
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Country [79]
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Germany
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State/province [79]
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Villingen-Schwenningen
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Country [80]
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Israel
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Beer Sheva
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Israel
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Jerusalem
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Country [82]
0
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Israel
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State/province [82]
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Kfar-Saba
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Country [83]
0
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Israel
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State/province [83]
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Petach Tiqwa
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Country [84]
0
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Israel
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State/province [84]
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Ramat Gan
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Country [85]
0
0
Israel
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State/province [85]
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Rambam
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Country [86]
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Israel
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State/province [86]
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Tel Aviv
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Country [87]
0
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Italy
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State/province [87]
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Campania
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Country [88]
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Italy
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State/province [88]
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Lazio
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Country [89]
0
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Italy
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State/province [89]
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Liguria
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Country [90]
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Italy
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State/province [90]
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Lombardia
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Country [91]
0
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Italy
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State/province [91]
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Puglia
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Country [92]
0
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Italy
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State/province [92]
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Sicilia
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Country [93]
0
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Italy
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State/province [93]
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Toscana
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Country [94]
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Italy
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State/province [94]
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Umbria
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Country [95]
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0
Japan
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Aichi
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Country [96]
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Japan
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State/province [96]
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Chiba
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Country [97]
0
0
Japan
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Ehime
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Country [98]
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Japan
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State/province [98]
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Fukuoka
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Country [99]
0
0
Japan
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Hyogo
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Country [100]
0
0
Japan
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Ibaraki
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Country [101]
0
0
Japan
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State/province [101]
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Kanagawa
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Country [102]
0
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Japan
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State/province [102]
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Kyoto
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Country [103]
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0
Japan
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Miyagi
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Country [104]
0
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Japan
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State/province [104]
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Niigata
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Country [105]
0
0
Japan
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Okayama
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Country [106]
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Japan
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Osaka
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Country [107]
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Japan
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Sakai-shi
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Country [108]
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Japan
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Satima
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Country [109]
0
0
Japan
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Shizuoka
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Country [110]
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Japan
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Tokyo
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Country [111]
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Latvia
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Riga
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Lithuania
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Vilnius
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Mexico
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Monterrey
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Country [114]
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Mexico
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Queretaro
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Country [115]
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0
Netherlands
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Amsterdam
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Country [116]
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0
Netherlands
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EDE
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Country [117]
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Netherlands
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Eindhoven
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Country [118]
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Netherlands
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Nieuwegein
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Peru
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Arequipa
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Peru
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Lima
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Peru
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Trujillo
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Country [122]
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Portugal
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Lisboa
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Portugal
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Porto
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Country [124]
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Country [127]
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Volgograd
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Singapore
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Singapore
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Country [130]
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Slovakia
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Bratislava
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Slovakia
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Poprad
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Islas Baleares
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Spain
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LA Coruña
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Spain
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LAS Palmas
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Spain
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Sevilla
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Spain
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Tenerife
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Spain
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Cordoba
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Spain
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Lugo
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Country [141]
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Spain
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Madrid
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Country [142]
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Spain
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Valencia
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Country [143]
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Spain
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Zaragoza
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Country [144]
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Taiwan
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Changhua
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Taiwan
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Kaohsiung City
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Taiwan
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Liuying Township
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Taiwan
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Putzu
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Country [148]
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Country [150]
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Taiwan
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Taipei
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Country [151]
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Ukraine
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Katerynoslav Governorate
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Country [152]
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Ukraine
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State/province [152]
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Kharkiv Governorate
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Country [153]
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Ukraine
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KIEV Governorate
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Ukraine
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Volhynian Governorate
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Country [155]
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Ukraine
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Chernivtsi
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Ukraine
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Kharkiv
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Country [157]
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Ukraine
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Kryvyi Rih
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Country [158]
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Ukraine
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Poltava
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Country [159]
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Ukraine
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Sumy
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab
(MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel
compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants
with Stage IV squamous NSCLC.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02367794
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Public notes
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Contacts
Principal investigator
Name
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0
Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02367794
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