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
This is a Phase III, global, multicenter, open-label, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve patients with locally advanced or metastatic NSCLC who are deemed unsuitable for platinum-containing therapy due to poor performance status (Eastern Cooperative Oncology Group performance status [ECOG PS] of 2-3).
However, if patients do not meet this criterion, they may be included if deemed unsuitable for platinum-containing therapy by the investigator due to:
a) substantial comorbidities
b) contraindication(s) for platinum-based antineoplastic drugs.
Eligible patients will be stratified by (a) histologic subtype (non-squamous vs squamous), (b) PD-L1 immunohistochemistry (IHC) status (positive/negative/unknown) and (c) brain metastases (yes/no) and then randomized at a 2:1 ratio to receive either atezolizumab or single agent chemotherapy.
Eligible patients must therefore provide a tumor tissue specimen for central assessment of PD-L1 expression by IHC at a central laboratory. The study will enroll all patients whose tissue is evaluable for PD-L1 analysis, regardless of PD-L1 expression status.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 441
- 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.
- 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).
- 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. Measured by overall survival (OS).
- Secondary Outcome Measures
Name Time Method Secondary Efficacy Objectives: The secondary efficacy objectives for this study are to evaluate the efficacy of atezolizumab compared with single agent chemotherapy as measured by OS rates at 6, 12, 18 and 24 months, antitumor effects as measured by investigator assessed ORR , progression-free survival (PFS) and duration of response (DOR) using RECIST v1.1 Safety Objectives To evaluate the safety and tolerability of atezolizumab compared with single agent chemotherapy Patient-reported Outcome Objectives: To evaluate and compare PROs of lung cancer symptoms, patient functioning, and health-related quality of life (HRQoL) between treatment arms as measured by the European Organisation for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13) Exploratory Objectives: To evaluate the efficacy with respect to antitumor effects as measured by investigator-assessed ORR, PFS, DOR and disease control rates (DCR) according to modified RECIST.
Trial Locations
- Locations (7)
HCG Cancer Center
🇮🇳Ahmadabad, GUJARAT, India
HCG Manavata Cancer Center
🇮🇳Nashik, MAHARASHTRA, India
Indraprastha Apollo Hospitals
🇮🇳Delhi, DELHI, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
🇮🇳Mumbai, MAHARASHTRA, India
Rajiv Gandhi Cancer Institute and Research Center
🇮🇳West, DELHI, India
Tata Medical Center
🇮🇳Kolkata, WEST BENGAL, India
Tata Memorial Centre
🇮🇳Mumbai, MAHARASHTRA, India
HCG Cancer Center🇮🇳Ahmadabad, GUJARAT, IndiaDr Ashish KaushalPrincipal investigator9978297842drashish4@yahoo.co.in