A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/1/2019 |
Start Date: | April 30, 2016 |
End Date: | November 30, 2019 |
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer
This is a randomized, Phase III, multicenter, open-label study designed to evaluate the
safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed
compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are
chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be
randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin +
Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in
two phases: Induction Phase and Maintenance Phase.
safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed
compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are
chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be
randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin +
Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in
two phases: Induction Phase and Maintenance Phase.
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC. Participants
with tumors of mixed non-small cell histology (i.e., squamous and non-squamous) are
eligible if the major histological component appears to be non-squamous
- No prior treatment for Stage IV non-squamous NSCLC. Participants with a sensitizing
mutation in the epidermal growth factor receptor (EGFR) gene or with an anaplastic
lymphoma kinase (ALK) fusion oncogene are excluded. Participants with unknown EGFR and
ALK status require test results at screening from a local or central laboratory
- Participants who have received prior neo-adjuvant, radiotherapy, adjuvant
chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease
must have experienced a treatment-free interval of at least 6 months from
randomization since the last dose of chemotherapy and/or radiotherapy
- Participants should submit a pre-treatment tumor tissue sample if available before or
within 4 weeks after enrollment. If tumor tissue is not available, participants are
still eligible
- For participants enrolled in the extended China enrollment phase: current resident of
mainland China, Hong Kong, or Taiwan and of Chinese ancestry
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function
- For women of childbearing potential: agreement to remain abstinent or use
contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per
year during the treatment period and for at least 5 months after the last dose of
atezolizumab or 6 months after the last dose of cisplatin
- For men: agreement to remain abstinent or use contraceptive measures and agreement to
refrain from donating sperm
Exclusion Criteria:
Cancer-Specific Exclusions
- Participants with a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
- Active or untreated central nervous system (CNS) metastases as determined by computed
tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and
prior radiographic assessments
- Spinal cord compression not definitively treated with surgery and/or radiation or
previously diagnosed and treated spinal cord compression without evidence that disease
has been clinically stable for greater than or equal to (>= 2) weeks prior to
randomization
- Leptomeningeal disease
- Uncontrolled tumor-related pain
- Uncontrolled or symptomatic hypercalcemia (greater than [>] 1.5 millimole/Liter
ionized calcium or calcium >12 milligrams/deciliter or corrected serum calcium >upper
limit of normal)
- Malignancies other than NSCLC within 5 years prior to randomization
- Known tumor programmed death-ligand 1 (PD-L1) expression status from other clinical
studies (e.g., participants whose PD-L1 expression status was determined during
screening for entry into a study with anti-PD-1 or anti-PD L1 antibodies but were not
eligible are excluded)
General Medical Exclusions:
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins
- History of certain autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
- All participants will be tested for human immunodeficiency virus (HIV) prior to the
inclusion into the study and HIV-positive participants will be excluded from the
clinical study
- Severe infections within 4 weeks prior to randomization
- Significant cardiovascular disease, such as New York Heart Association cardiac disease
(Class II or greater), myocardial infarction or cerebrovascular accident within 3
months prior to randomization, unstable arrhythmias, or unstable angina
- Illness or condition that may interfere with a participant's capacity to understand,
follow, and/or comply with study procedures
Exclusion Criteria Related to Medications and Chemotherapy:
- Prior treatment with EGFR inhibitors or ALK inhibitors
- Any approved anti-cancer therapy, including hormonal therapy within 21 days prior to
initiation of study treatment
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks prior to randomization
- Treatment with systemic immunosuppressive medications
Exclusion Criteria Related to Chemotherapy:
- History of allergic reactions to cisplatin, carboplatin, or other platinum-containing
compounds
- Participants with hearing impairment (cisplatin)
- Grade >=2 peripheral neuropathy as defined by National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria (cisplatin)
- Creatinine clearance (CRCL) <60 milliliters/minute (mL/min) for cisplatin or <45
mL/min for carboplatin
We found this trial at
35
sites
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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726 Avenida Luis María Campos
Buenos Aires, C1426
Buenos Aires, C1426
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1100 Meade Street
Dunmore, Pennsylvania 18512
Dunmore, Pennsylvania 18512
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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