Clinical Trials /

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)

NCT02409355

Description:

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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02409355

Trial Eligibility

Document

Title

  • Brief Title: 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)
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GO29432
  • SECONDARY ID: 2014-003106-33
  • NCT ID: NCT02409355

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
AtezolizumabMPDL3280A; TecentriqAtezolizumab
CarboplatinGemcitabine + Cisplatin/Carboplatin
CisplatinGemcitabine + Cisplatin/Carboplatin
GemcitabineGemcitabine + Cisplatin/Carboplatin

Purpose

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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Trial Arms

NameTypeDescriptionInterventions
AtezolizumabExperimentalParticipants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
  • Atezolizumab
Gemcitabine + Cisplatin/CarboplatinActive ComparatorParticipants 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.
  • Carboplatin
  • Cisplatin
  • Gemcitabine

Eligibility 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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Hoffmann-La Roche

Last Updated

February 15, 2019