RecruitingPhase 1Phase 2NCT05416775

Phase Ib/II Study of SHR-8068 Injection in the Treatment of Advanced Non-small Cell Lung Cancer

An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

168 participants

Start Date

Aug 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SHR-8068 for people with advanced non-small cell lung cancer (NSCLC) — the most common type of lung cancer. The drug is being tested both alone and in combination with other treatments, and the study aims to find the right dose and understand how well it works. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with non-small cell lung cancer that cannot be cured with surgery - Your cancer has progressed after standard treatments, or you have not yet received chemotherapy for advanced disease - You are in good enough physical condition to participate (able to carry out light work or self-care) - Your liver, kidneys, and blood counts are functioning adequately **You may NOT be eligible if...** - Your cancer has spread to the brain in an uncontrolled way - You have significant heart conditions - You have active autoimmune disease - You have received prior immunotherapy that caused serious side effects - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-8068;Adebrelimab

SHR-8068: Sterile Injection, 50mg/10mL, Intravenous Infusion Adebrelimab: injection, 600mg/12mL, intravenous infusion

DRUGSHR-8068;adebrelimab and platinum-based chemotherapy

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

DRUGAdebrelimab;platinum-based chemotherapy

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


Locations(18)

Anhui Chest Hospital

Hefei, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

West China Hospital Of Sichuan University

Chengdu, Chengdu, China

Cancer Hospital Affiliated to Chongqing University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

North Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Jilin Cancer Hospital

Changchun, Jilin, China

Affiliated Tumor Hospital of Shandong First Medical University

Jinan, Shandong, China

Yunnan Cancer Hospital

Kunming, Yunan, China

View Full Details on ClinicalTrials.gov

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NCT05416775


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