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Trial record 1 of 1 for:    29437
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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]

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02367794
First received: February 13, 2015
Last updated: June 12, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Squamous Non-Small Cell Lung Cancer Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody Drug: Carboplatin Drug: Nab-Paclitaxel Drug: Paclitaxel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Tumor Gene Expression (tGE) Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • PFS as Determined by the Investigator Using RECIST v1.1 in the Intent-to-Treat (ITT) Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • Overall Survival (OS) in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]

Secondary Outcome Measures:
  • OS in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 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 (Arm A vs Arm C, Arm B vs Arm C) [ 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 (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • OS in the TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • OS in the TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ 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 tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ 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 (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Duration of Response as Determined by the Investigator Using RECIST v1.1 in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • Percentage of Participants Alive at 1 and 2 Years in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: 1 and 2 years ]
  • Percentage of Participants Alive at 1 and 2 Years in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: 1 and 2 years ]
  • Time to Deterioration(TTD) in Patient-reported Lung Cancer Symptoms Using European Organisation for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core (QLQ-C30) Subscales in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • TTD in Patient-reported Lung Cancer Symptoms Using EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Subscales in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after the first participant enrolled ]
  • TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Up to approximately 39 months after the first participant enrolled ]
  • Change from Baseline in Patient-reported Lung Cancer Symptoms Score using the Symptoms in Lung Cancer (SILC) Scale Symptom Severity Score in the tGE Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 39 months after first participant enrolled ]
  • Change from Baseline in Patient-reported Lung Cancer Symptoms Score using the SILC Scale Symptom Severity Score in the ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 39 months after first participant enrolled ]
  • PFS as Determined by the Investigator Using RECIST v1.1 in the TC2/3 or IC2/3 Population (Arm A vs Arm B) [ 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 (Arm A vs Arm B) [ Time Frame: Up to approximately 30 months after first participant enrolled ]
  • OS in the TC2/3 or IC2/3 Population (Arm A vs Arm B) [ Time Frame: Up to approximately 39 months after first participant enrolled ]
  • OS in the TC1/2/3 or IC1/2/3 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) ]

Estimated Enrollment: 1025
Actual Study Start Date: June 11, 2015
Estimated Study Completion Date: February 15, 2023
Estimated Primary Completion Date: January 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02367794

  Show 317 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02367794     History of Changes
Other Study ID Numbers: GO29437
2014-003208-59 ( EudraCT Number )
Study First Received: February 13, 2015
Last Updated: June 12, 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017