Study of TQB2450 Combined With Anlotinib in the Treatment of Mutation Positive Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03983928|
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: TQB2450 Drug: Anlotinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib, Open-label, Single Center, Non-randomized Study for Safety and Efficacy of TQB2450 Combined With Anlotinib in Subjects With Advanced Mutation Positive Non-Small Cell Lung Cancer|
|Actual Study Start Date :||June 3, 2019|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: TQB2450 Combined with Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
a multi-target receptor tyrosine kinase inhibitor
- Overall response rate （ORR） [ Time Frame: up to approximately 12 months ]Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)
- Progression-free survival (PFS) [ Time Frame: up to approximately 12 months ]PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
- Overall survival (OS) [ Time Frame: up to approximately 15 months ]OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
- Disease control rate（DCR） [ Time Frame: up to approximately 12 months ]Percentage of Participants 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): NCT03983928
|Contact: Li Zhangemail@example.com|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Li Zhang 020-87343458 firstname.lastname@example.org|