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Trial record 1 of 2 for:    29436
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A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) 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) (IMpower150)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02366143
First received: February 12, 2015
Last updated: June 9, 2017
Last verified: June 2017
  Purpose
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab 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 will be 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).

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab Drug: Bevacizumab Drug: Carboplatin 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, 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

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) for 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: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Investigator Using RECIST v1.1 for Intent-to-Treat (ITT) Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Overall Survival (OS) for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until death (up to approximately 44 months) ]
  • OS for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until death (up to approximately 44 months) ]

Secondary Outcome Measures:
  • Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • DOR as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • DOR as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Time to Response (TTR) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • TTR as Determined by the Investigator Using ECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • TTR as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Time in Response (TIR) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • TIR as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • TIR as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • Percentage of Participants Who are Alive at Year 1 and 2 [ Time Frame: Year 1 and 2 ]
  • Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score for ITT Population [ Time Frame: Baseline up to approximately 44 months ]
    The comparison for EORTC QLQ-C30 score will be done as Arm A vs Arm C, and Arm B vs Arm C.

  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-C30 Score for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-C30 Score for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-LC13 Score for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-LC13 Score for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale for ITT Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the SILC Scale for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the SILC Scale for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C) [ Time Frame: Baseline up to approximately 44 months ]
  • PFS as Determined by the Investigator using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm B) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm B) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • PFS as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm B) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 44 months) ]
  • OS for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm B) [ Time Frame: Baseline until death (up to approximately 44 months) ]
  • OS for ITT Population (Arm A vs Arm B) [ Time Frame: Baseline until death (up to approximately 44 months) ]
  • Maximum Observed Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Arm A and B: Predose on Day (D) 1 of Cycle (Cy) 1,2,3,4,8,16 & every 8 cycles thereafter (1 Cy=21 days), 0.5 hours (h) post-infusion on D1 of Cy1,3, at treatment discontinuation & at 120 days after last atezolizumab dose (up to approximately 44 months) ]
    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 Concentration (Cmin) of Atezolizumab Prior to Infusion [ Time Frame: Arm A and B: Predose (same day of treatment administration) on D1 of Cy1,2,3,4,8,16 and every 8 cycles thereafter (1 Cy=21 days), at treatment discontinuation and at 120 days after last atezolizumab dose (up to approximately 44 months) ]
  • Plasma Concentrations for Carboplatin [ Time Frame: Arm A, B and C: 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 (1Cy=21 days) ]
  • Plasma Concentrations for Paclitaxel [ Time Frame: Arm A, B and C: 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 (1Cy=21 days) ]
  • Cmax of Bevacizumab [ Time Frame: Arm B and C: Predose (same day of treatment administration), 0.5 h after bevacizumab infusion (infusion duration=30 to 90 minutes) on D1 of Cy1,3 (1 Cy=21 days), at bevacizumab discontinuation (up to approximately 44 months) ]
  • Cmin of Bevacizumab [ Time Frame: Arm B and C: Predose (same day of treatment administration) on D1 of Cy1,3 (1 Cy=21 days), at bevacizumab discontinuation (up to approximately 44 months) ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 44 months ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Arm A and B: Predose (same day of treatment administration) on D1 of Cy1,2,3,4,8,16, and every 8 cycles thereafter (1 Cy=21 days), at treatment discontinuation and at 120 days after last atezolizumab dose (up to approximately 44 months) ]

Enrollment: 1202
Actual Study Start Date: March 31, 2015
Estimated Study Completion Date: July 15, 2018
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (Atezolizumab + Paclitaxel + Carboplatin)
Participants will receive 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 will receive IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Drug: Atezolizumab
Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.
Other Name: MPDL3280A, Tecentriq
Drug: Carboplatin
Carboplatin will be 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.
Drug: Paclitaxel
Paclitaxel will be 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.
Experimental: Arm B (Atezolizumab + Bevacizumab + Paclitaxel + Carboplatin)
Participants will receive 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 will receive IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Drug: Atezolizumab
Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.
Other Name: MPDL3280A, Tecentriq
Drug: Bevacizumab
Bevacizumab will be 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.
Drug: Carboplatin
Carboplatin will be 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.
Drug: Paclitaxel
Paclitaxel will be 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.
Active Comparator: Arm C (Bevacizumab + Paclitaxel + Carboplatin)
Participants will receive 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 will receive IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Drug: Bevacizumab
Bevacizumab will be 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.
Drug: Carboplatin
Carboplatin will be 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.
Drug: Paclitaxel
Paclitaxel will be 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.

  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, Stage IV non-squamous NSCLC
  • Participants with no prior treatment for Stage IV non-squamous NSCLC
  • Known PD-L1 status as determined by immunohistochemistry (IHC) 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

Exclusion Criteria:

Cancer-Specific Exclusions:

  • Active or untreated central nervous system (CNS) 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 (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
  • Severe infection within 4 weeks prior to randomization
  • Significant cardiovascular disease

Exclusion Criteria Related to Medications:

  • Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibodies
  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: NCT02366143

  Show 286 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: NCT02366143     History of Changes
Other Study ID Numbers: GO29436
2014-003207-30 ( EudraCT Number )
Study First Received: February 12, 2015
Last Updated: June 9, 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
Bevacizumab
Carboplatin
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors

ClinicalTrials.gov processed this record on June 23, 2017