A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04523272
• Collaborator: (none)
• Enrollment: 418
• Locations: 26
• Arms: 2
• Anticipated Duration (Months): 33.2
• Patients Per Site: 16.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus sunitinib in subjects with advanced renal cancer.

Condition or Disease	Intervention/Treatment	Phase
Advanced Renal Cancer	Drug: TQB2450; Drug: Anlotinib; Drug: Sunitinib	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 418 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer
• Actual Study Start Date: Aug 25, 2020
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TQB2450 + Anlotinib TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, 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.
Active Comparator: Sunitinib Malate Capsules Sunitinib malate capsule 50mg administered orally, once daily in 28-day cycle(14 days on treatment from Day 1-14, 14 days off treatment from day 15-28).	Drug: Sunitinib; A multi-target receptor tyrosine kinase inhibitor.

Outcome Measures

Primary Outcome Measures

1. Progression free survival (PFS) evaluated by Independent Review Committee(IRC) [up to 60 weeks]

   PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.

Secondary Outcome Measures

1. Progression free survival (PFS) evaluated by investigator [up to 60 weeks]

   PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.

2. Overall survival (OS) [up to 60 weeks]

   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.

3. Disease control rate（DCR） [up to 60 weeks]

   Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

4. Duration of response（DOR） [up to 60 weeks]

   The time when the participants first achieved complete or partial remission to disease progression.

5. Progression-free survival at 12 months [up to 12 months]

   Percentage of participants whose PFS has achieved at least 12 months.

6. Overall survival at 12 months [up to 12 months]

   Percentage of participants whose OS has achieved at least 12 months.

7. Overall survival at 24 months [up to 24 months]

   Percentage of participants whose OS has achieved at least 24 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Histopathologically confirmed renal clear cell cancer, including advanced renal cell carcinoma with clear cell components.

1. Has not receiving systemic therapy for local advanced/metastatic disease. 3. At least has one measurable lesion. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

2. Adequate laboratory indicators. 6. Agree to provide at least 5 slices tumor tissue samples for biomarker detection.

3. Serum or urine pregnancy tests are negative within 7 days before randomization; Men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months.

4. Understood and signed an informed consent form.

Exclusion Criteria:

• 1. Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease.

1. Has received anti-angiogenesis targeted therapy or targeted PD-1 and PD-L1 immunotherapy.

2. Has active virus, bacteria, fungal infection; Cardiovascular and cerebrovascular diseases; Gastrointestinal abnormalities; Immunodeficiency; Bleeding risk; Lung disease; Neurological or psychiatric disorders.

3. Has participated in other clinical trials within 30 days before randomization.

4. Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.

5. Pregnant or lactating women. 7. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China	230601
2	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021
3	China-Japan Friendship Hospital	Beijing	Beijing	China	100029
4	Peking Union Medical College Hospital	Beijing	Beijing	China	100032
5	Peking University First Hospital	Beijing	Beijing	China	100034
6	Beijing Cancer Hospital	Beijing	Beijing	China	100142
7	Peking University Third Hospital	Beijing	Beijing	China	100191
8	Chinese PLA General Hospital	Beijing	Beijing	China	100853
9	Chongqing University Cancer Hospital	Chongqing	Chongqing	China	400000
10	Fujian Provincial Hospital	Fuzhou	Fujian	China	350001
11	Sun Yat-sen of Cancer Center	Guangzhou	Guangdong	China	510060
12	The Affiliated Tumor Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150081
13	Hunan Cancer Hospital	Changsha	Hunan	China	410006
14	The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008
15	Jiangxi Cancer Hospital	Nanchang	Jiangxi	China	330029
16	The First Hospital of Jilin University	Changchun	Jilin	China	130021
17	The Second Hospital of Dalian Medical University	Dalian	Liaoning	China	116027
18	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning	China	110042
19	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012
20	Tenth People's Hospital of Tongji University	Shanghai	Shanghai	China	200072
21	The First Affiliated Hospital of PLA Air Force Military Medical University	Xi'an	Shanxi	China	711400
22	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041
23	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin	China	300000
24	First Affiliated Hospital,School of Medicine,Shihezi University	Shihezi	Xinjiang	China	832008
25	The Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang	China	830000
26	Cancer Hospital of The University of Chinese Academy of Sciences	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04523272
• Other Study ID Numbers: TQB2450-III-07
• First Posted: Aug 21, 2020
• Last Update Posted: Sep 10, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell; Sunitinib

Study Results

No Results Posted as of Sep 10, 2020