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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]

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ClinicalTrials.gov Identifier: NCT02409342
Recruitment Status : Active, not recruiting
First Posted : April 6, 2015
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 572 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 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
Actual Study Start Date : July 20, 2015
Estimated Primary Completion Date : January 17, 2019
Estimated Study Completion Date : April 23, 2020


Arm Intervention/treatment
Active Comparator: (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Participants 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).
Drug: Carboplatin
Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) 6 when given in combination with pemetrexed or at a dose of AUC 5 when given in combination with gemcitabine, every 21 days for 4 or 6 cycles as per local standard of care.

Drug: Cisplatin
Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (mg/m^2) every 21 days for 4 or 6 cycles as per local standard of care.

Drug: Gemcitabine
Gemcitabine will be administered as intravenous infusion at a dose of 1250 mg/m^2 (in combination with cisplatin) or 1000 mg/m^2 (in combination with carboplatin), on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles as per local standard of care.

Drug: Pemetrexed
Pemetrexed will be administered as intravenous infusion at a dose of 500 mg/m^2 on Day 1 of each 21-day cycle as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).

Experimental: Atezolizumab
Participants 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).
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Atezolizumab 1200 milligram (mg) will be administered as intravenous infusion every 21 days until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Other Name: MPDL3280A, RO5541267




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization to death from any cause (maximum up to approximately 58 months) ]

Secondary Outcome Measures :
  1. 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: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 58 months) ]
  2. 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) ]
  3. Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 [ Time Frame: From the first occurrence of a complete response (CR) or partial response (PR), whichever occurs first, until the first date that progressive disease or death is documented, whichever occurs first (up to approximately 58 months) ]
  4. Percentage of Participants Who are Alive at 1 and 2 Years [ Time Frame: 1 and 2 Years ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) [ Time Frame: Baseline up to approximately 58 months ]
  9. OS in Participants with PD-L1 Expression [ Time Frame: From randomization to death from any cause (maximum up to approximately 58 months) ]
  10. Investigator-Assessed PFS in Participants with PD-L1 Expression According to RECIST v1.1 [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 58 months) ]
  11. OS in Participants with Blood Tumor Mutational Burden (bTMB) [ Time Frame: From randomization to death from any cause (maximum up to approximately 58 months) ]
  12. Investigator-Assessed PFS in Participants with bTMB According to RECIST v1.1 [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 58 months) ]

Other Outcome Measures:
  1. Minimum Observed Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, at treatment discontinuation, and at 120 days after the last dose of atezolizumab (maximum up to approximately 58 months) (cycle duration = 21 days) ]
  2. Maximum Observed Serum Concentration (Cmax) of Atezolizumab [ Time Frame: 0 hour (predose) and 30 minutes after atezolizumab infusion on Day 1 (infusion duration = up to 1 hour) ]
  3. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 90 days after the last dose of study treatment (maximum up to approximately 58 months) ]
  4. Percentage of Participants With Anti-therapeutic Antibodies (ATAs) [ Time Frame: Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eighth cycle thereafter, at treatment discontinuation, and at 120 to 150 days after the last dose of atezolizumab (maximum up to approximately 58 months) (cycle duration = 21 days) ]


Information from the National Library of Medicine

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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 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

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): NCT02409342


  Show 198 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02409342     History of Changes
Other Study ID Numbers: GO29431
2014-003083-21 ( EudraCT Number )
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 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
Pemetrexed
Antibodies
Immunoglobulins
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
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors