NCT04523272.

Study name	‐
Methods	Study type: RCT, parallel assignment, phase III Blinding: no, open‐label Accrual period: August 25, 2020 ‐ June 2023 Countries: multicentre (26 study locations) Cross‐over study: no Status: Recruiting (as of September 10, 2020)
Participants	Estimated enrolment: N = 418 Inclusion criteria: histopathologically confirmed renal clear cell cancer, including advanced renal cell carcinoma with clear cell components has not received systemic therapy for local advanced/metastatic disease at least has one measurable lesion Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months adequate laboratory indicators agree to provide at least 5 slices tumour tissue samples for biomarker detection serum or urine pregnancy tests are negative within 7 days before randomisation; Men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months all sexes, 18 ‐ 80 years old Exclusion criteria: has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease has received anti‐angiogenesis targeted therapy or targeted PD‐1 and PD‐L1 immunotherapy has active virus, bacteria, fungal infection; cardiovascular and cerebrovascular diseases; gastrointestinal abnormalities; Immunodeficiency; bleeding risk; lung disease; neurological or psychiatric disorders has participated in other clinical trials within 30 days before randomisation has received attenuated live vaccine within 28 days before randomisation or planned to received attenuated live vaccine during the study period *Other protocol‐defined inclusion/exclusion criteria apply
Interventions	Experimental arm: TQB2450 + anlotinib Control arm: sunitinib mMalate capsules
Outcomes	Primary outcome(s): PFS evaluated by Independent Review Committee(IRC) [ Time frame: up to 60 weeks ] PFS defined as the time from randomisation until the first documented progressive disease (PD) or death from any cause, based on IRC Secondary outcome(s): Progression‐free survival (PFS) evaluated by investigator (time frame: up to 60 weeks) OS (time frame: up to 60 weeks) PFS at 12 months (time frame: up to 12 months) OS at 12 months (time frame: up to 12 months) OS at 24 months (time frame: up to 24 months) Relevant to this review but not reported: QoL, AEs/SAEs, TFST, number of patients who discontinued treatment Other outcomes (not relevant to this review): DCR, DoR,
Starting date	August 25, 2020
Contact information	Jun Guo, Doctor
Notes	Funding source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd