| 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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
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)
|
Drug: TQB2450
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.
Drug: Anlotinib a multi-target receptor tyrosine kinase inhibitor
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ system function, defined as follows:
Exclusion Criteria:
Has any of the following severe acute complications:
Virological test indicates one of the following items before enrollment:
| Contact: Li Zhang | 020-87343458 | zhangli@sysucc.org.cn |
| China, Guangdong | |
| Sun Yat-sen University Cancer Center | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Li Zhang 020-87343458 zhangli@sysucc.org.cn | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 10, 2019 | ||||
| First Posted Date ICMJE | June 12, 2019 | ||||
| Last Update Posted Date | August 15, 2019 | ||||
| Actual Study Start Date ICMJE | June 3, 2019 | ||||
| Estimated Primary Completion Date | October 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Overall response rate (ORR) [ Time Frame: up to approximately 12 months ] Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of TQB2450 Combined With Anlotinib in the Treatment of Mutation Positive Lung Cancer | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | This is an open-label, single center, non-randomized, phase Ib trial to evaluate safety and efficacy of TQB2450 injection combined with anlotinib in patients with advanced mutation positive non-small cell lung cancer. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE | 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)
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
30 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 31, 2020 | ||||
| Estimated Primary Completion Date | October 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03983928 | ||||
| Other Study ID Numbers ICMJE | TQB2450-Ib-11 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
| Study Sponsor ICMJE | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
| Verification Date | August 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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