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Trial record 3 of 6 for:    Atezolizumab Lung | Recruiting Studies | Germany

A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC) (IMpower133)

This study is currently recruiting participants.
Verified August 2017 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT02763579
First Posted: May 5, 2016
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study is designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

Condition Intervention Phase
Small Cell Lung Carcinoma Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Drug: Carboplatin Drug: Etoposide Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 [ Time Frame: Baseline until PD or death, whichever occurs first (up to approximately 37 months) ]
  • Duration of Overall Survival (OS) [ Time Frame: Baseline until death from any cause (up to approximately 37 months) ]

Secondary Outcome Measures:
  • Percentage of Participants With Objective Response (OR) as Assessed by the Investigator Using RECIST v1.1 [ Time Frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 37 months) ]
  • Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 [ Time Frame: First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 37 months) ]
  • Time in Response (TIR) as Assessed by the Investigator Using RECIST v1.1 [ Time Frame: Baseline until PD or death, whichever occurs first (up to approximately 37 months) ]
  • Time to Response (TTR) as Assessed by the Investigator Using RECIST v1.1 [ Time Frame: Baseline until PR or CR, whichever occurs first (up to approximately 37 months) ]
  • Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 1 Year [ Time Frame: 6 months, 1 year ]
  • Percentage of Participants Alive at 1 Year and 2 Years [ Time Frame: 1 year, 2 years ]
  • Time to Deterioration (TTD) per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) Score [ Time Frame: Baseline until deterioration per symptom subscale (up to approximately 37 months) ]
  • TTD per EORTC QLQ Lung Cancer Module (LC13) Score [ Time Frame: Baseline until deterioration per symptom subscale (up to approximately 37 months) ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline until up to 90 days after end of treatment (up to approximately 37 months) ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) [ Time Frame: Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 37 months) and 120 days after last dose (up to approximately 37 months overall) ]
  • Maximum Observed Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Predose (0 H) and postdose (0.5 H) on D1 of C1; predose (0 H) on D1 of C2, 3, 4, 8, 16, and Q8C thereafter (cycle = 21 days) until treatment discontinuation (up to 37 months) and 120 days after last dose (up to approximately 37 months overall) ]
    Atezolizumab infusion duration is 60 minutes for the first infusion and 30 minutes for subsequent infusions.

  • Minimum Observed Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Predose (0 H) on D1 of C1, 2, 3, 4, 8, 16, and Q8C thereafter (cycle = 21 days) until treatment discontinuation (up to 37 months) and 120 days after last dose (up to approximately 37 months overall) ]
    Atezolizumab infusion duration is 60 minutes for the first infusion and 30 minutes for subsequent infusions.

  • Plasma Concentration of Carboplatin [ Time Frame: Predose (0 H) and 5-10 minutes before end/1 H after end of carboplatin infusion (infusion duration = 1 H) on D1 of C1 and C3 (cycle = 21 days) ]
  • Plasma Concentration of Etoposide [ Time Frame: Predose (0 H) and 5-10 minutes before end/1 H and 4H after end of etoposide infusion (infusion duration = 1 H) on D1 of C1 and C3 (cycle = 21 days) ]

Estimated Enrollment: 500
Actual Study Start Date: June 7, 2016
Estimated Study Completion Date: August 1, 2019
Estimated Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atezolizumab + Carboplatin + Etoposide
Participants will receive intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 will be administered alone. Thereafter, participants will receive maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
Other Name: MPDL3280A, RO5541267, Tecentriq
Drug: Carboplatin
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min will be administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
Drug: Etoposide
Etoposide intravenous infusion will be administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
Active Comparator: Placebo + Carboplatin + Etoposide
Participants will receive intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m^2 will be administered alone. Thereafter, participants will receive maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Drug: Carboplatin
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min will be administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
Drug: Etoposide
Etoposide intravenous infusion will be administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
Drug: Placebo
Placebo intravenous infusion will be administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
  • No prior systemic treatment for ES-SCLC
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Measurable disease, as defined by RECIST v1.1
  • Adequate hematologic and end organ function
  • Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC

Exclusion Criteria:

  • Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
  • Malignancies other than SCLC 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 result for human immunodeficiency virus (HIV)
  • Active hepatitis B or hepatitis C
  • Severe infections at the time of randomization
  • Significant cardiovascular disease
  • Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibody
  • History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation
  Contacts and Locations
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): NCT02763579


Contacts
Contact: Reference Study ID Number: GO30081 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 135 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02763579     History of Changes
Other Study ID Numbers: GO30081
2015-004861-97 ( EudraCT Number )
First Submitted: May 4, 2016
First Posted: May 5, 2016
Last Update Posted: August 2, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Lung Diseases
Atezolizumab
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Diseases
Etoposide phosphate
Carboplatin
Etoposide
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action