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A Phase III Study of MPDL3280A (Anti-PD-L1 Antibody) in Combination With Carboplatin + Nab-Paclitaxel in Patients With Non-Squamous Non-Small Cell Lung Cancer [IMpower 130]

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02367781
First received: February 13, 2015
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This randomized Phase III, multicenter, open-label study is designed to evaluate the safety and efficacy of Atezolizumab (MPDL3280A) in combination with carboplatin + Nab-paclitaxel compared with treatment with carboplatin + Nab-paclitaxel in chemotherapy-naive patients with Stage IV non-squamous non-small cell lung cancer (NSCLC).

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]
Drug: Carboplatin
Drug: Nab-paclitaxel
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of 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) [ Time Frame: Up to 2.5 years ]

Secondary Outcome Measures:
  • Objective Response as determined by the Investigator using RECIST v1.1 [ Time Frame: Up to 2.5 years ]
  • Overall Survival [ Time Frame: Up to 3.5 years ]
  • Duration of Response as determined by the Investigator using RECIST v1.1 [ Time Frame: Up to 2.5 years ]
  • PFS as determined by the Independent Review Facility using RECIST v1.1 [ Time Frame: Up to 2.5 years ]
  • Time to Deterioration (TTD) in patient-reported Lung Cancer Symptoms [ Time Frame: Up to 2.5 years ]
  • Change from Baseline in patient-reported Lung Cancer Symptoms [ Time Frame: Up to 2.5 years ]
  • Safety: Incidence of Adverse Events [ Time Frame: Up to 2.5 years ]

Estimated Enrollment: 650
Study Start Date: April 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atezolizumab (MPDL3280A) + Nab-Paclitaxel + Carboplatin
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]
1200 mg intravenous (IV) infusion on Day 1 of each 21-day cycle
Drug: Carboplatin
Area under the concentration curve (AUC) 6 on Day 1 of each 21-day cycle for 4 or 6 cycles
Drug: Nab-paclitaxel
100 mg/m2 IV on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles
Active Comparator: 2
Nab-Paclitaxel + Carboplatin
Drug: Carboplatin
Area under the concentration curve (AUC) 6 on Day 1 of each 21-day cycle for 4 or 6 cycles
Drug: Nab-paclitaxel
100 mg/m2 IV on Days 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:

  • 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically confirmed, treatment-naive 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:

  • 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
  • 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 CD137 agonists or immune checkpoint blockade therapies, 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: NCT02367781

Contacts
Contact: Reference Study ID Number: GO29537 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 159 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: November 1, 2016

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
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 March 23, 2017