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A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy (IMpower210)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813785
Recruitment Status : Active, not recruiting
First Posted : June 27, 2016
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab compared with docetaxel in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Treatment may continue until disease progression, loss of clinical benefit, or unacceptable toxicity.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 565 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atezolizumab
Participants will receive atezolizumab until loss of clinical benefit and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other Name: MDPL3280A, RO5541267

Active Comparator: Docetaxel
Participants will receive docetaxel until disease progression per standard RECIST v1.1 criteria or unacceptable toxicity and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.
Drug: Docetaxel
Docetaxel will be administered as 75 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 21-day cycle.
Other Name: Taxotere




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Baseline until death from any cause (up to approximately 3 years) ]

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [ Time Frame: Baseline until disease progression or death from any cause (up to approximately 3 years) ]
  2. Percentage of Participants with Objective Response According to RECIST v1.1 [ Time Frame: Baseline until disease progression or death from any cause (up to approximately 3 years) ]
  3. Duration of Objective Response According to RECIST v1.1 [ Time Frame: From first objective response until disease progression or death from any cause (up to approximately 3 years) ]
  4. Percentage of Participants with Adverse Events [ Time Frame: From start of treatment until 90 days after treatment discontinuation or initiation of other anti-cancer therapy (up to approximately 3 years) ]
  5. Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall) ]
  6. Minimum Observed Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall) ]
  7. Time to Deterioration (TTD) in Lung Cancer Symptoms According to European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 C30) [ Time Frame: From start of treatment until treatment discontinuation (up to approximately 3 years) ]
  8. TTD in Lung Cancer Symptoms According to EORTC QLQ Lung Cancer Module (LC13) [ Time Frame: From start of treatment until treatment discontinuation (up to approximately 3 years) ]
  9. Health-Related Quality of Life According to EORTC QLQ-C30 Score [ Time Frame: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) ]
  10. Health-Related Quality of Life According to EORTC QLQ-LC13 Score [ Time Frame: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) ]


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 documented, locally advanced or metastatic NSCLC
  • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or at least 12 unstained, freshly cut serial sections with associated pathology report that are evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR) mutation status prior to enrollment, except for known sensitizing EGFR mutations in which case 10 unstained slides are required and there is no need for central testing of EGFR mutation status
  • Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable, inoperable, or metastatic NSCLC, or disease recurrence within 6 months of treatment with a platinum-based adjuvant and/or neoadjuvant regimen or combined modality with curative intent
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than or equal to (>/=) 12 weeks
  • Adequate hematologic and end organ function
  • Agreement to remain abstinent or use contraceptive methods among women of childbearing potential or male partners of women of childbearing potential
  • Recovery from all acute toxicities from previous therapy

Exclusion Criteria:

  • Active or untreated central nervous system (CNS) metastases
  • Spinal cord compression not definitively treated or not clinically stable
  • Leptomeningeal disease
  • Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia
  • Malignancies other than NSCLC within 5 years prior to randomization, except for those curatively treated with negligible risk of metastasis or death
  • Pregnant or lactating women
  • Significant cardiovascular, pulmonary, or autoimmune disease
  • Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2 weeks prior to randomization
  • Prior treatment with or hypersensitivity to study drug(s) or related compounds
  • Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors
  • Prior allogeneic bone marrow or solid organ transplant
  • Known PD-L1-negative expression status
  • Positive human immunodeficiency virus (HIV) or active hepatitis B or C
  • Receipt of a live attenuated vaccine within 4 weeks prior to randomization
  • Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever is shorter) prior to randomization
  • Treatment with systemic corticosteroids within 2 weeks prior to randomization

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): NCT02813785


Locations
Show Show 38 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02813785    
Other Study ID Numbers: YO29232
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
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
Docetaxel
Atezolizumab
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action