A Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer
|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: NCT04306926|
Recruitment Status : Not yet recruiting
First Posted : March 13, 2020
Last Update Posted : March 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Oligometastatic Non-small Cell Lung Cancer||Drug: TQB2450 Radiation: SBRT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Open-label, Single-arm, Phase II Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||May 30, 2023|
SBRT three days before TQB2450.
TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.
Give according to the location of the lesion and clinical condition.
- Progression-Free Survival (PFS) [ Time Frame: Baseline up to 96 weeks ]PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
- Objective response rate (ORR) [ Time Frame: Baseline up to 96 weeks ]Percentage of subjects achieving complete response (CR) and partial response (PR).
- Overall survival (OS) [ Time Frame: Baseline up to 96 weeks ]OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
- Disease control rate（DCR） [ Time Frame: Baseline up to 96 weeks ]Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
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): NCT04306926
|Contact: Hongqing Zhuang, Doctoremail@example.com|
|Beijing Cancer Hospital|
|Beijing, Beijing, China, 100142|
|Contact: Huiming Yu, Doctor|
|Principal Investigator: Huiming Yu, Doctor|
|Peking University Third Hospital|
|Beijing, Beijing, China, 100191|
|Contact: Hongqing Zhuang, Doctor firstname.lastname@example.org|
|Principal Investigator: Hongqing Zhuang, Doctor|
|Huashan Hospital Fudan University|
|Shanghai, Shanghai, China, 200040|
|Contact: Enmin Wang, Doctor|
|Principal Investigator: Enmin Wang, Doctor|
|Tianjin Medical University Cancer institute and Hospital|
|Tianjin, Tianjin, China, 300060|
|Contact: Zhiyong Yuan, Doctor|
|Principal Investigator: Zhiyong Yuan, Doctor|