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Trial record 1 of 1 for:    GO29436
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A Phase III Study of MPDL3280A (Anti-PD-L1 Antibody) in Combination With Carboplatin + Paclitaxel With or Without Bevacizumab in Patients With Stage IV Non-squamous Non-small Cell Lung Cancer [IMpower 150]

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:
NCT02366143
First received: February 12, 2015
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This randomized, open-label study will evaluate the safety and efficacy of Atezolizumab (MPDL3280A) in combination with carboplatin and paclitaxel with or without bevacizumab compared with treatment with carboplatin plus (+) paclitaxel and bevacizumab in chemotherapy-naïve 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: Bevacizumab
Drug: Carboplatin
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Randomized Study of 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 (NSCLC)

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 (RECIST v1.1) [ Time Frame: up to 2 years ]

Secondary Outcome Measures:
  • Objective Response as determined by the Investigator using RECIST v1.1 [ Time Frame: up to 2 years ]
  • Overall Survival (OS) [ Time Frame: up to 7 years ]
  • Duration of response as determined by the Investigator using RECIST v1.1 [ Time Frame: up to 2 years ]
  • PFS as determined by the Independent Review Facility using RECIST v1.1 [ Time Frame: up to 2 years ]
  • OS at 1 and 2 Years [ Time Frame: Years 1 and 2 ]
  • Time to deterioration (TTD) in patient-reported Lung Cancer Symptoms [ Time Frame: up to 2 years ]
  • Change from baseline in patient-reported Lung Cancer Symptoms [ Time Frame: up to 2 years ]
  • Safety: Incidence of Adverse Events [ Time Frame: up to 2 years ]

Estimated Enrollment: 1200
Study Start Date: March 2015
Estimated Study Completion Date: November 2022
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atezolizumab (MPDL3280A) + Paclitaxel + Carboplatin Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]
1200 mg intravenous infusion (IV) 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: Paclitaxel
200 mg/m^2 IV, Day 1 of each 21-day cycle for 4 or 6 cycles
Experimental: Atezolizumab (MPDL3280A)+Bevacizumab+Paclitaxel+Carboplatin Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]
1200 mg intravenous infusion (IV) on day 1 of each 21-day cycle
Drug: Bevacizumab
15 mg/kg IV 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: Paclitaxel
200 mg/m^2 IV, Day 1 of each 21-day cycle for 4 or 6 cycles
Active Comparator: Bevacizumab + Paclitaxel + Carboplatin Drug: Bevacizumab
15 mg/kg IV 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: Paclitaxel
200 mg/m^2 IV, Day 1 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 0 or 1
  • Histologically or cytologically confirmed, treatment-naïve Stage IV non-squamous NSCLC
  • 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:

  • 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 PD1, 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: NCT02366143

Contacts
Contact: Reference Study ID Number: GO29436 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 290 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
Study First Received: February 12, 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
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 March 24, 2017