Atezolizumab in Combination With Bevacizumab, Carboplatin and Pemetrexed for EGFR-mutant Metastatic NSCLC Patients After Failure of EGFR Tyrosine Kinase Inhibitors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03647956|
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : April 17, 2019
This project will recruit 40 EGFR-mutant metastatic non-small cell lung cancer patients who failed any EGFR tyrosine kinase inhibitors.
All recruited patients will receive 1200mg Azetolizumab administered over 60 minutes (1st cycle) and 30 minutes (2nd cycle onwards) intravenously, as well as 7.5mg/kg bevacizumab administered over 90 minutes (1st cycle), 60 minutes (2nd cycle) and 30 minutes (3rd cycle onwards) for every 3 weeks, until radiographically documented disease progression, unacceptable toxicity as judged by investigators or patient withdrawal.
The primary objective is to assess the progression-free survival of this treatment population, and to identify potential genomic and immunologic biomarkers for treatment response. Objective response rate (ORR) will be the primary efficacy endpoint.
|Condition or disease||Intervention/treatment||Phase|
|NSCLC Stage IIIB NSCLC Stage IV EGFR Activating Mutation||Drug: Atezolizumab Drug: Bevacizumab Drug: Carboplatin Drug: Pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Atezolizumab in Combination With Bevacizumab, Carboplatin and Pemetrexed for EGFR-mutant Metastatic Non-small Cell Lung Cancer Patients After Failure of EGFR Tyrosine Kinase Inhibitors: a Single Arm Phase 2 Study|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||April 3, 2020|
Experimental: Arm 1
Using Atezolizumab, a PD-L1 inhibitor, in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.
Atezolizumab (trade name Tecentriq) is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1).
Other Name: Tecentriq
Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A).
Other Name: Avastin
Carboplatin, sold under the trade name Paraplatin among others, is a chemotherapy medication used to treat a number of forms of cancer.
Other Name: Paraplatin
Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are the treatment of pleural mesothelioma and non-small cell lung cancer.
Other Name: Alimta
- Objective response rate (ORR) [ Time Frame: 3 years ]The percentage of patients with radiologically complete or partial response as determined by the investigator according to RECIST version 1.1.
- Progression-free Survival (PFS) [ Time Frame: 3 years ]
PFS is measured from the date of study enrollment to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first).
Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.
- Time to progression (TTP) [ Time Frame: 3 years ]TTP is measured from the date of study enrollment to radiographically documented progression according to RECIST 1.1. This does not include death from any cause.
- Duration of response (DoR) [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647956
|Contact: Tai-Chung Lam, FRCRemail@example.com|
|Department of Clinical Oncology||Recruiting|
|Hong Kong, Hong Kong|
|Principal Investigator: Tai-Chung Lam, FRCR|
|Sub-Investigator: Chi-Leung Chiang, FRCR|
|Sub-Investigator: Victor Ho-Fun Lee, MD|
|Sub-Investigator: Tsz-Him So, MBBS|
|Principal Investigator:||Tai-Chung Lam, FRCR||The University of Hong Kong|