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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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ClinicalTrials.gov Identifier: NCT02367794
Recruitment Status : Active, not recruiting
First Posted : February 20, 2015
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE February 13, 2015
First Posted Date  ICMJE February 20, 2015
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE June 11, 2015
Actual Primary Completion Date October 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • 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 [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • Overall Survival (OS) in the ITT Population [ Time Frame: Up to approximately 39 months after first participant enrolled ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
Progression Free Survival (PFS) as determined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: up to 2 years ]
Change History Complete list of historical versions of study NCT02367794 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • OS in the Tumor Gene Expression (tGE) Population [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • PFS as Determined by the Investigator Using RECIST v1.1 in the tGE Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • 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 [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • OS in the TC2/3 or IC2/3 Population [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • OS in the TC1/2/3 or IC1/2/3 Population [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • OS at 1 and 2 Years in the ITT Population [ Time Frame: 1 and 2 years ]
    OS rates 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
  • Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population [ Time Frame: Up to approximately 30 months after the first participant enrolled ]
  • Change from Baseline in Patient-reported Lung Cancer Symptoms Score using the SILC Scale Symptom Severity Score in the ITT Population [ Time Frame: Baseline up to approximately 30 months after first participant enrolled ]
  • PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A vs. Arm B) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • OS in the ITT Population (Arm A vs. Arm B) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Percentage of Participants with Anti-therapeutic Antibody (ATA) Response to Atezolizumab [ Time Frame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 39 months), at treatment discontinuation (up to 39 months), and at 120 days after the last dose of atezolizumab (up to approximately 39 months, each cycle is 21 days) ]
    The predose samples will be collected on the same day of treatment administration.
  • Maximum Observed Serum Atezolizumab Concentration (Cmax) [ Time Frame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle up to 39 months; 30 minutes postdose on Day 1 of Cycles 1 and 3; at treatment discontinuation (up to 39 months), and at 120 days after last dose of atezolizumab (up to 39 months, each cycle is 21 days) ]
    The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
  • Minimum Observed Serum Atezolizumab Concentration (Cmin) [ Time Frame: Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 39 months), at treatment discontinuation (up to 39 months), and at 120 days after the last dose of atezolizumab (up to approximately 39 months, each cycle is 21 days) ]
    The predose samples will be collected on the same day of treatment administration.
  • Plasma Concentrations for Paclitaxel [ Time Frame: 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) ]
  • Plasma Concentrations for Nab-Paclitaxel [ Time Frame: 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) ]
  • Plasma Concentrations for Carboplatin [ Time Frame: 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
  • Objective Response as determined by the Investigator using RECIST v1.1 [ Time Frame: up to 2 years ]
  • Overall Survival (OS) [ Time Frame: up to 7 years ]
  • Duration of Response as Determined by the Investigator Using RECIST v1.1 [ Time Frame: up to 2 years ]
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 [ Time Frame: up to 2 years ]
  • OS at 1 and 2 Years [ Time Frame: Years 1 and 2 ]
  • Time to deterioration (TTD) in patient-reported Lung Cancer Symptoms [ Time Frame: up to 2 years ]
  • Change from Baseline in patient-reported Lung Cancer Symptoms [ Time Frame: up to 2 years ]
  • Safety: Incidence of Adverse Events [ Time Frame: up to 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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]
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: 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.
    Other Name: Tecentriq
  • Drug: 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.
  • Drug: 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.
  • Drug: 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • 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.
    Interventions:
    • Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody
    • Drug: Carboplatin
    • Drug: Nab-Paclitaxel
  • 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.
    Interventions:
    • Drug: Carboplatin
    • Drug: Nab-Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 6, 2017)
1021
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2015)
1200
Estimated Study Completion Date  ICMJE February 15, 2023
Actual Primary Completion Date October 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   France,   Germany,   Israel,   Italy,   Japan,   Latvia,   Lithuania,   Mexico,   Netherlands,   Peru,   Portugal,   Russian Federation,   Singapore,   Slovakia,   Spain,   Switzerland,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02367794
Other Study ID Numbers  ICMJE GO29437
2014-003208-59 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP