|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03022500|
Recruitment Status : Unknown
Verified June 2018 by Bhumsuk Keam, Seoul National University Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 16, 2017
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Durvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma, NSCLC||Drug: durvalumab + tremelimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Durvalumab + Tremelimumab in Pulmonary Sarcomatoid Carcinoma|
|Actual Study Start Date :||May 18, 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: durvalumab + tremelimumab
Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.
Drug: durvalumab + tremelimumab
Durvalumab: 1.5g Q4W plus Tremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.
- Response rate (RR) [ Time Frame: 24month ]modified RECIST1.1
- Progression-Free Survival (PFS) [ Time Frame: 24month ]
- Overall Survival (OS) [ Time Frame: 24month ]
- Toxicity [ Time Frame: 24month ]number of patients with treatment-related AE as assessed by NCI CTCAE version 4.0
- biomarker [ Time Frame: 24month ]TGS(NGS)
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): NCT03022500
|Korea, Republic of|
|Department of Internal Medicine, Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Bhumsuk Kim, Ph.D.||Seoul National University Hospital|