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A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02367781
First received: February 13, 2015
Last updated: July 13, 2017
Last verified: July 2017
  Purpose
This randomized Phase III, multicenter, open-label study is designed to evaluate the safety and efficacy of atezolizumab in combination with carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 2:1 ratio to Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin) or Arm B (Nab-Paclitaxel + Carboplatin).

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab Drug: Carboplatin Drug: Nab-Paclitaxel Drug: Pemetrexed Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive 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 Intent-to-Treat (ITT) Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • PFS as Determined by the Investigator Using RECIST v1.1 for PD-L1-Selected Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • Overall Survival (OS) for ITT Population [ Time Frame: Baseline until death (up to approximately 48 months) ]
  • OS for PD-L1-Selected Population [ Time Frame: Baseline until death (up to approximately 48 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 [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 for PD-L1-Selected Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 for ITT Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • DOR as Determined by the Investigator Using RECIST v1.1 for PD-L1-Selected Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • Time to Response (TTR) as Determined by the Investigator Using RECIST v1.1 for ITT Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • TTR as Determined by the Investigator Using RECIST v1.1 for PD-L1-Selected Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • Time in Response (TIR) as Determined by the Investigator Using RECIST v1.1 for ITT Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • TIR as Determined by the Investigator Using RECIST v1.1 for PD-L1-Selected Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for ITT Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 months) ]
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for PD-L1-Selected Population [ Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 48 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 48 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-C30 Score for PD-L1-Selected Population [ Time Frame: Baseline up to approximately 48 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) for ITT Population [ Time Frame: Baseline up to approximately 48 months ]
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-LC13 for PD-L1-Selected Population [ Time Frame: Baseline up to approximately 48 months ]
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale for ITT Population [ Time Frame: Baseline up to approximately 48 months ]
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the SILC Scale for PD-L1-Selected Population [ Time Frame: Baseline up to approximately 48 months ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 48 months ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Predose on Day (D) 1 of Cycle (Cy) 1,2,3,4,8,16, and every 8 cycles thereafter (1 Cy=21 days), at treatment discontinuation (up to 48 months), and at 120 days after last atezolizumab dose (up to approximately 48 months) ]
    Predose samples will be collected on the same day of treatment administration.

  • Maximum Observed Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Arm A: Predose on D1 of Cy1,2,3,4,8,16, and every 8 cycles thereafter (1 Cy=21 days), 0.5 hours (h) post-infusion on D1 of Cy1,3, at treatment discontinuation (up to 48 months), and at 120 days after last atezolizumab dose (up to approximately 48 months) ]
    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: 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 (up to 48 months), and at 120 days after last atezolizumab dose (up to approximately 48 months) ]
  • Plasma Concentrations of Carboplatin [ Time Frame: 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 of Nab-Paclitaxel Reported as Total Paclitaxel [ Time Frame: Predose (same day of treatment administration), 5-10 minutes before end of nab-paclitaxel infusion, 1 h after nab-paclitaxel infusion (infusion duration=30 minutes) on D1 of Cy1,3 (1Cy=21 days) ]
  • Cmax of Atezolizumab in Arm B Participants Who Received Atezolizumab During Maintenance Phase [ Time Frame: Predose on D1 of Cy1A,2A,3A,4A,8A,16A, and every 8 cycles thereafter (1 Cy=21 days), 0.5 h post-infusion on D1 of Cy1A,3A, at treatment discontinuation (up to 48 months), and at 120 days after last atezolizumab dose (up to approximately 48 months) ]
    Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.

  • Cmin of Atezolizumab Prior to Infusion in Arm B Participants Who Received Atezolizumab During Maintenance Phase [ Time Frame: Predose on D1 of Cy1A,2A,3A,4A,8A,16A, and every 8 cycles thereafter (1 Cy=21 days), at treatment discontinuation (up to 48 months), and at 120 days after last atezolizumab dose (up to approximately 48 months) ]
    Predose samples will be collected on the same day of treatment administration.


Enrollment: 724
Actual Study Start Date: April 30, 2015
Estimated Study Completion Date: October 15, 2018
Estimated Primary Completion Date: December 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)
Participants will receive intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 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. Atezolizumab will be administered to participants who are randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression.
Other Name: MPDL3280A, Tecentriq
Drug: Carboplatin
Carboplatin will be administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
Drug: Nab-Paclitaxel
Nab-paclitaxel will be administered as IV infusion at a dose of 100 milligrams per square meter (mg/m^2) on Days 1, 8, and 15 of each 21-day cycle.
Active Comparator: Arm B (Nab-Paclitaxel + Carboplatin)
Participants will receive IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Drug: Atezolizumab
Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Atezolizumab will be administered to participants who are randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression.
Other Name: MPDL3280A, Tecentriq
Drug: Carboplatin
Carboplatin will be administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
Drug: Nab-Paclitaxel
Nab-paclitaxel will be administered as IV infusion at a dose of 100 milligrams per square meter (mg/m^2) on Days 1, 8, and 15 of each 21-day cycle.
Drug: Pemetrexed
Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle.

  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 of 0 or 1
  • Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
  • Measurable disease, as defined by RECIST v1.1
  • Previously obtained archival tumor or tissue obtained from a biopsy at screening
  • 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
  • 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 (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: NCT02367781

  Show 157 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: NCT02367781     History of Changes
Other Study ID Numbers: GO29537
2014-003206-32 ( EudraCT Number )
Study First Received: February 13, 2015
Last Updated: July 13, 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
Pemetrexed
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 21, 2017