Real-World Indian Study of Atezolizumab in Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 36
- 主要终点
- To estimate the overall survival (OS) at two years in patients who receive Tecentriq® for the treatment of lung cancer in routine clinical practice. The OS will be estimated separately for the first-line metastatic non-small cell lung cancer (1LmNSCLC), adjuvant NSCLC, and first-line extensive-stage small cell lung cancer (1LES SCLC).
研究概览
简要总结
IMPACT is a REAL-WORLD INDIAN STUDY OF ATEZOLIZUMAB IN LUNG CANCER of Atezolizumab in patients with Lung Cancer treated as per routine clinical practice. The study will be conducted with 40 centers across India with an estimated sample size of 500 patients. Primary objective of the study is to estimate the overall survival (patients who receive Tecentriq for the treatment of lung cancer (NSCLC and SCLC) in routine clinical practice. Inclusion criteria for the study is patients of NSCLC and SCLC, above 18 years of age, Patients who have been prescribed Tecentriq for the medical management of their disease practice, Written informed consent. Exclusion criteria for the study is Known or suspected hypersensitivity to Tecentriq, Pregnant or lactating who decline consent
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent.
- •Male and female patients of NSCLC/SCLC, more than equal to 18 years of age.
- •Patients who have been prescribed Tecentriq® for the medical management in routine clinical practice according to the standard of care and in line with the current Indian prescribing information (local label).
- •Patients who have received less than equal to 3 cycle of Tecentriq® therapy at screening visit.
排除标准
- •Patients not receiving treatment for lung cancer with Tecentriq® according to standard of care and in line with the current prescribing information.
- •Known or suspected hypersensitivity to Tecentriq®
- •Pregnant or lactating women.
结局指标
主要结局
To estimate the overall survival (OS) at two years in patients who receive Tecentriq® for the treatment of lung cancer in routine clinical practice. The OS will be estimated separately for the first-line metastatic non-small cell lung cancer (1LmNSCLC), adjuvant NSCLC, and first-line extensive-stage small cell lung cancer (1LES SCLC).
时间窗: OS at two years
次要结局
- 1. To estimate PFS in patients treated with Tecentriq for metastatic lung cancer (1L mNSCLC, 1L ES SCLC) & DFS in those treated with Tecentriq® in an adjuvant NSCLC setting in routine clinical practice. 2. To estimate the ORR, DCR, & DoR in patients who receive Tecentriq for the treatment of approved indications in metastatic setting (1L mNSCLC, 1L ES SCLC) in routine clinical practice. 3. To evaluate the Safety of Atezolizumab for the treatment of lung cancer (NSCLC & SCLC) in routine clinical practices on the basis of the following endpoint: Incidence, nature, & severity of all AEs, SAEs, & AESIs according to NCI CTCAE v5.0. 4. To estimate the proportion of patients who are prescribed Tecentriq & undergo PD-L1 testing & molecular testing in routine clinical practice along with details on the assay type & results. 5. To evaluate the association between patient characteristics & treatment outcomes in routine clinical practice.(From the date of start of Tecentriq therapy to the first date of objectively determined response or death from any cause)
研究者
Dr Jaishid Ahdal
Roche Product India Pvt Ltd