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A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

NCT02409342

Description:

This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

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

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]
  • Official Title: A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: GO29431
  • SECONDARY ID: 2014-003083-21
  • NCT ID: NCT02409342

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibodyMPDL3280A, RO5541267Atezolizumab
Carboplatin(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Cisplatin(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Gemcitabine(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Pemetrexed(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Purpose

This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

Trial Arms

NameTypeDescriptionInterventions
(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)Active ComparatorParticipants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
  • Carboplatin
  • Cisplatin
  • Gemcitabine
  • Pemetrexed
AtezolizumabExperimentalParticipants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
  • Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC

          -  No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to
             have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an
             anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study

          -  Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival
             tumor tissue or tissue obtained at screening

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

          -  Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST
             v1.1)

          -  Adequate hematologic and end-organ function

        Exclusion Criteria:

          -  Known sensitizing mutation in the EGFR gene or ALK fusion oncogene

          -  Active or untreated central nervous system (CNS) metastases as determined by Computed
             Tomography (CT) or magnetic resonance imaging (MRI) evaluation

          -  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 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 cluster of differentiation (CD) 137 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:From randomization to death from any cause (maximum up to approximately 58 months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free Survival (PFS) Time as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame:Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of the Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression (maximum up to approximately 58 months)
Safety Issue:
Description:
Measure:Percentage of Participants With Objective Response (ORR) as Determined by the Investigator Using RECIST v1.1
Time Frame:Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of the Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression (maximum up to approximately 58 months)
Safety Issue:
Description:
Measure:Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1
Time Frame:Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of the Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression (maximum up to approximately 58 months)
Safety Issue:
Description:
Measure:Percentage of Participants Who are Alive at 1 and 2 Years
Time Frame:1 and 2 Years
Safety Issue:
Description:
Measure:Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score
Time Frame:Baseline up to approximately 58 months
Safety Issue:
Description:
Measure:Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score
Time Frame:Baseline up to approximately 58 months
Safety Issue:
Description:
Measure:TTD as Assessed Using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (EORTC QLQ-C30)
Time Frame:Baseline up to approximately 58 months
Safety Issue:
Description:
Measure:TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13)
Time Frame:Baseline up to approximately 58 months
Safety Issue:
Description:

Details

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

Last Updated

February 27, 2018