To evaluate the tolerability and safety of SHR-8068 in combination with adebrelimab in subjects with advanced NSCLC To evaluate the efficacy of SHR-8068 in combination with adebrelimab and platinum-based chemotherapy in subjects with advanced NSCLC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
SHR-8068: Sterile Injection, 50mg/10mL, Intravenous Infusion Adebrelimab: injection, 600mg/12mL, intravenous infusion
SHR-8068: Intravenous Infusion Adebrelimab: injection, intravenous infusion Pemetrexed disodium for injection: , intravenous drip Paclitaxel for injection (albumin-bound): intravenous drip Paclitaxel injection: intravenous drip Carboplatin injection: intravenous drip Cisplatin injection: intravenous drip
Adebrelimab: intravenous infusion Pemetrexed disodium for injection: intravenous drip Paclitaxel for injection (albumin-bound): intravenous drip Paclitaxel injection: intravenous drip Carboplatin injection: intravenous drip Cisplatin injection: intravenous drip
Anhui Chest Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGDose limiting toxicity
Time frame: The observation period is 21 days after the first dose
Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points;
Time frame: up to 2 years
Disease Control Rate, determined using RECIST v1.1 criteria
Time frame: up to 2 years
Progression-Free-Survival assessed by investigator
Time frame: up to 2 years
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Anhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGWest China Hospital Of Sichuan University
Chengdu, Chengdu, China
NOT_YET_RECRUITINGCancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
NOT_YET_RECRUITINGGuizhou Provincial People's Hospital
Guiyang, Guizhou, China
NOT_YET_RECRUITINGAffiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITING...and 8 more locations