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Trial record 1 of 1 for:    NCT02367781
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A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)

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ClinicalTrials.gov Identifier: NCT02367781
Recruitment Status : Active, not recruiting
First Posted : February 20, 2015
Results First Posted : April 3, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Squamous Non-Small Cell Lung Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Drug: Carboplatin Drug: Nab-Paclitaxel Drug: Pemetrexed Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 723 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Actual Study Start Date : April 16, 2015
Actual Primary Completion Date : March 15, 2018
Estimated Study Completion Date : December 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
Participants will receive intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants will receive IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Atezolizumab will be administered to participants who are randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression.
Other Name: MPDL3280A, RO5541267, Tecentriq

Drug: Carboplatin
Carboplatin will be administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.

Drug: Nab-Paclitaxel
Nab-paclitaxel will be administered as IV infusion at a dose of 100 milligrams per square meter (mg/m^2) on Days 1, 8, and 15 of each 21-day cycle.

Active Comparator: Arm B (Nab-Paclitaxel+Carboplatin)
Participants will receive IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Atezolizumab will be administered to participants who are randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression.
Other Name: MPDL3280A, RO5541267, Tecentriq

Drug: Carboplatin
Carboplatin will be administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.

Drug: Nab-Paclitaxel
Nab-paclitaxel will be administered as IV infusion at a dose of 100 milligrams per square meter (mg/m^2) on Days 1, 8, and 15 of each 21-day cycle.

Drug: Pemetrexed
Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle.




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) in the ITT-WT Population [ Time Frame: Up to approximately 35 months after first patient enrolled ]
    PFS is reported for the ITT-WT population. The term "wild type" (WT) refers to randomized participants who do not have a sensitizing EGFR mutation or ALK translocation.

  2. Overall Survival (OS) in the ITT-WT Population [ Time Frame: Up to approximately 35 months after first patient enrolled ]
    OS is reported for the ITT-WT population. The term "wild type" (WT) refers to randomized participants who do not have a sensitizing EGFR mutation or ALK translocation.


Secondary Outcome Measures :
  1. PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population [ Time Frame: Up to approximately 56 months after first subject enrolled ]
  2. OS as Determined by the Investigator Using Recist v1.1 in the ITT Population [ Time Frame: Up to approximately 56 months after first subject enrolled ]
  3. Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population [ Time Frame: Up to approximately 56 months after first subject enrolled ]
  4. Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 in ITT-WT Population [ Time Frame: Up to approximately 56 months after first subject enrolled ]
  5. Percentage of Participants Who Are Alive at Year 1 and 2 in ITT-WT Population [ Time Frame: Up to 56 months after first patient enrolled ]
  6. Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population [ Time Frame: Up to approximately 56 months after first subject enrolled ]
    Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire−Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.

  7. Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale [ Time Frame: Up to approximately 56 months after first subject enrolled ]
  8. Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 56 months after first subject enrolled ]
  9. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Up to approximately 56 months after first subject enrolled ]
  10. Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm [ Time Frame: Predose on Day (D) 1 of Cycle (Cy) 1,2,3,4,8,16 and every 8 cycles thereafter up to end of treatment (EOT) (approximately 41 months), 0.5 hours (h) post-infusion on D1 of Cy1,3, at 120 days after EOT (up to approximately 56 months) ]
    Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.

  11. Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel [ Time Frame: Predose on D1 of Cy 1, 2, 3, 4, 8, 16 and every 8 cycles thereafter up to EOT (approximately 41 months), at 120 days after EOT (up to approximately 56 months) ]
    Predose samples will be collected on the same day of treatment administration.

  12. Plasma Concentrations of Carboplatin [ Time Frame: Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (1Cy=21 days) (up to approximately 56 months) ]
  13. Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel [ Time Frame: Predose (same day of treatment administration), 5-10 minutes before end of nab-paclitaxel infusion, 1 h after nab-paclitaxel infusion (infusion duration=30 minutes) on D1 of Cy1,3 (1Cy=21 days) (up to approximately 56 months) ]


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:

  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
  • Participants with no prior treatment for Stage IV non-squamous NSCLC
  • Previously obtained archival tumor tissue or tissue obtained from fresh biopsy at screening
  • Measurable disease, as defined by RECIST v1.1
  • Adequate hematologic and end organ function

Exclusion Criteria:

Cancer-Specific Exclusions:

  • Active or untreated central nervous system 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

General Medical Exclusions:

  • 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 scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Positive test for human immunodeficiency virus
  • Active hepatitis B or hepatitis C
  • Severe infection within 4 weeks prior to randomization
  • Significant cardiovascular disease
  • Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures

Exclusion Criteria Related to Medications:

  • Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies

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): NCT02367781


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

Documents provided by Hoffmann-La Roche:

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02367781     History of Changes
Other Study ID Numbers: GO29537
2014-003206-32 ( EudraCT Number )
First Posted: February 20, 2015    Key Record Dates
Results First Posted: April 3, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pemetrexed
Atezolizumab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors