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A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower150)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02366143
First Posted: February 19, 2015
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants 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
Carcinoma, Non-Small-Cell Lung Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 1.1) [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 32 months) ]
  • Overall Survival (OS) [ Time Frame: Baseline until death (up to approximately 32 months) ]

Secondary Outcome Measures:
  • PFS as Determined by the Independent Review Facility (IRF) Using RECIST v1.1 [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 40 months) ]
  • Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 40 months) ]
  • Percentage of Participants Who are Alive at Years 1 and 2 [ Time Frame: Years 1 and 2 ]
  • Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score [ Time Frame: Baseline up to approximately 40 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score [ Time Frame: Baseline up to approximately 40 months ]
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale [ Time Frame: Baseline up to approximately 40 months ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 40 months ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Arms A and B: Baseline up to approximately 40 months ]
  • Maximum Observed Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Arms A and B: Predose on Day (D) 1 of Cycle (Cy) 1,2,3,4,8,16 and every 8 cycles thereafter up to end of treatment (EOT) (approximately 40 months), 0.5 hours (h) post-infusion on D1 of Cy1,3, at 120 days after EOT (up to approximately 40 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: Arms A and B: Predose on D1 of Cy 1, 2, 3, 4, 8, 16 and every 8 cycles thereafter up to end of treatment (EOT) (approximately 40 months), at 120 days after EOT (up to approximately 40 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: Arms A and B: Predose on Day (D) 1 of Cycle (Cy) 1,2,3,4,8,16 and every 8 cycles thereafter up to end of treatment (EOT) (approximately 40 months), 0.5 hours (h) post-infusion on D1 of Cy1,3, at 120 days after EOT (up to approximately 40 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) ]

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 (MPDL3280A), an engineered anti-PD-L1 antibody
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 Names:
  • MPDL3280A
  • RO5541267
  • 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 (MPDL3280A), an engineered anti-PD-L1 antibody
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 Names:
  • MPDL3280A
  • RO5541267
  • 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

Information from the National Library of Medicine

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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 performance status 0 or 1
  • Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
  • Participants with no prior treatment for Stage IV non-squamous NSCLC
  • Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
  • Measurable disease as defined by RECIST v1.1
  • Adequate hematologic and end organ function

Exclusion Criteria:

Cancer-Specific Exclusions:

  • Active or untreated central nervous system metastases
  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome

General Medical Exclusions:

  • Pregnant or lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Positive test for human immunodeficiency virus
  • Active hepatitis B or hepatitis C
  • Severe infection within 4 weeks prior to randomization
  • Significant cardiovascular disease
  • Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures

Exclusion Criteria Related to Medications:

  • Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Submitted: February 12, 2015
First Posted: February 19, 2015
Last Update Posted: October 11, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Atezolizumab
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antibodies
Immunoglobulins
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