A clinical trial to study the efficacy and safety of Atezolizumab compared with standard Chemotherapy in Non-Small Cell Lung Cancer patients with poor performance status.
- Registration Number
- CTRI/2017/11/010690
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Signed Informed Consent Form
2. Women or men aged =18 years
3. Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
4. No sensitizing epidermal growth factor receptor (EGFR) mutation (L858R or exon 19 deletions) or anaplastic lymphoma kinase (ALK) fusion oncogene detected
5. No prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
6.Life expectancy = 8 weeks
7.Deemed unsuitable for platinum-containing chemotherapy by the investigator due to poor performance status (ECOG PS of 2-3)
8. Measurable disease, as defined by RECIST v1.1.
9. For female patients of childbearing potential and male patients with partners of childbearing potential randomized to the treatment arm: agreement (by patient and/or partner) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraceptive methods that result in a failure rate of < 1% per year when used consistently and correctly during the treatment period and for 5 months after the last dose of atezolizumab.
1. Active or untreated CNS metastases
2. Uncontrolled tumor-related pain
3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
4. NCI CTCAE (v4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
5. Pregnant or lactating women, or intending to become pregnant during the study.
6.History of autoimmune disease
7.History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
8.Known positivity for human immunodeficiency virus (HIV)
9.Known active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or known active hepatitis C
10. Active tuberculosis
11.Severe infections within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
12.Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
13. Major surgical procedure other than for diagnosis within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study
14. Prior allogeneic bone marrow transplantation or solid organ transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective for this study is to evaluate the efficacy of atezolizumab compared with single agent chemotherapy in patients with treatment-naïve locally advanced or metastatic NSCLC who are deemed unsuitable for platinum-containing therapy.Timepoint: Measured by overall survival (OS).
- Secondary Outcome Measures
Name Time Method