For Healthcare Professionals

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

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Histologically documented, locally advanced or metastatic NSCLC
  2. 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
  3. 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
  4. Measurable disease per RECIST v1.1
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Life expectancy greater than or equal to (>/=) 12 weeks
  7. Adequate hematologic and end organ function
  8. Agreement to remain abstinent or use contraceptive methods among women of childbearing potential or male partners of women of childbearing potential
  9. Recovery from all acute toxicities from previous therapy

EXCLUSION CRITERIA

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

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 888-662-6728 (U.S. and Canada)Email iconEmail Study Center

Study’s details


Contition

Carcinoma, Non-Small-Cell Lung,Non-Small Cell Lung Cancer

Age

18+

Phase

Phase 3

Participants needed

565

Est. Completion Date

Dec 2022

Treatment type

Interventional


Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT02813785

Study number

YO29232

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.