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A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)

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ClinicalTrials.gov Identifier: NCT02409355
Recruitment Status : Terminated (The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342.)
First Posted : April 6, 2015
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Atezolizumab Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Actual Study Start Date : May 7, 2015
Actual Primary Completion Date : December 7, 2017
Actual Study Completion Date : December 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Atezolizumab
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
Drug: Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.
Other Name: MPDL3280A; Tecentriq

Active Comparator: Gemcitabine + Cisplatin/Carboplatin
Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
Drug: Carboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.

Drug: Cisplatin
Cisplatin will be administered at 75 milligrams per square meter (mg/m^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.

Drug: Gemcitabine
Gemcitabine will be administered at 1000 mg/m^2 (when coadministered with carboplatin) or 1250 mg/m^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed Stage IV squamous NSCLC
  • Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
  • No prior treatment for Stage IV squamous NSCLC
  • Measurable disease as defined by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematologic and end-organ function

Exclusion Criteria:

  • Active or untreated central nervous system (CNS) metastases
  • Untreated or inadequately treated spinal cord compression
  • Leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia
  • Any other malignancies within 5 years except those with negligible risk of metastasis or death
  • Pregnant or lactating women
  • Known hypersensitivity to any component of atezolizumab formulation or other study medication
  • History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
  • Prior allogeneic bone marrow or solid organ transplantation
  • Positive human immunodeficiency virus (HIV) test
  • Active hepatitis B or C
  • Active tuberculosis
  • Significant cardiovascular disease
  • Severe infection or major surgery within 4 weeks prior to randomization
  • Use of any approved anti-cancer therapy within 3 weeks prior to treatment
  • Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
  • Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
  • Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
  • Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization

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): NCT02409355


  Show 82 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02409355     History of Changes
Other Study ID Numbers: GO29432
2014-003106-33 ( EudraCT Number )
First Posted: April 6, 2015    Key Record Dates
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018
Last Verified: November 2018

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
Gemcitabine
Atezolizumab
Cisplatin
Carboplatin
Antibodies, Monoclonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs