A Study to Investigate the Safety and Efficacy of Atezolizumab in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03922997|
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Atezolizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Singe Arm, Multicenter Study to Investigate the Safety and Efficacy of Atezolizumab (Tecentriq) in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer|
|Estimated Study Start Date :||June 3, 2019|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2022|
Participants will receive atezolizumab intravenously on the first day of each cycle. Atezolizumab treatment will continue until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).
Atezolizumab will be administered at a fixed dose of 1200 mg intravenously on the first day of each 21-day cycle.
Other Name: Tecentriq
- Serious Adverse Event Incidence Rates [ Time Frame: Baseline up to approximately 30 months ]The incidence of serious adverse events (SAEs) related to atezolizumab.
- Overall Survival (OS) Rate [ Time Frame: Baseline to 2 years ]Overall survival (OS) rate at 2 years, defined as the proportion of patients remaining alive 2 years after initiation of study treatment
- OS [ Time Frame: Baseline up to approximately 30 months ]Overall survival (OS), defined as the time from initiation of study treatment to death from any cause
- Progression-Free Survival (PFS) [ Time Frame: Baseline up to approximately 30 months ]Progression-free survival (PFS), defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.
- Objective Response Rate (ORR) [ Time Frame: Baseline up to approximately 30 months ]Objective response rate (ORR), defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1 and also by disease status evaluated by the investigator according to modified RECIST
- Duration of Response (DOR) [ Time Frame: Baseline up to approximately 30 months ]Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study.
- EQ-5D-5L Index-Based and VAS scores [ Time Frame: Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 30 months) ]EQ-5D-5L, EuroQol 5-Dimension Questionnaire is a self-report health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. The EuroQol EQ-5D has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort and anxiety/depression, as well as a visual analog scale (VAS) that measures health state. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.
- EORTC QLQ-LC13 score [ Time Frame: Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 30 months) ]EORTC QLQ-LC13, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire—Supplemental Lung Cancer Module will be used to assess self-reported outcomes. EORTC QLQ-LC13 includes 13 items that address key lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related adverse effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. The dysphagia scale is multi-item, while the rest are single-item scales.
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): NCT03922997
|Contact: Reference Study ID Number: ML40471 www.roche.com/about_roche/roche_worldwide.htm||888-662-6728 (U.S. and Canada)||firstname.lastname@example.org|
|Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department||Not yet recruiting|
|Hangzhou City, China, 310022|
|Study Director:||Clinical Trials||Hoffmann-La Roche|