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

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 Overview

• Status: Recruiting
• Conditions: Advanced Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: SHR-8068；Adebrelimab; Drug: SHR-8068；adebrelimab and platinum-based chemotherapy; Drug: Adebrelimab；platinum-based chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xin Xu; Phone Number: 0518-82342973; Email: xin.xu@hengrui.com
• Study Contact Backup: Name: Weixia Li; Phone Number: 0518-82342973; Email: weixia.li@hengrui.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Not yet recruiting
      • Anhui Chest Hospital
      • Principal Investigator: Haohui Fang
    • Hefei, Anhui, China, 230000
      • Not yet recruiting
      • Anhui Provincial Hospital
      • Principal Investigator: Xinghua Han
  • Chengdu
    • Chengdu, Chengdu, China, 610000
      • Not yet recruiting
      • West China Hospital of Sichuan University
      • Principal Investigator: Yan Zhang
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Not yet recruiting
      • Cancer Hospital Affiliated to Chongqing University
      • Principal Investigator: Yongsheng Li
  • Guangxi Zhuang Autonomous Region
    • Nanning, Guangxi Zhuang Autonomous Region, China, 530022
      • Not yet recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Principal Investigator: Zhiyi He
  • Guizhou
    • Guiyang, Guizhou, China, 550002
      • Not yet recruiting
      • Guizhou Provincial People's Hospital
      • Principal Investigator: Yu Zhang
    • Zunyi, Guizhou, China, 563003
      • Not yet recruiting
      • Affiliated Hospital of Zunyi Medical University
      • Principal Investigator: Liang Zhou
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Not yet recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Not yet recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Principal Investigator: Gunjun Zhang
    • Zhengzhou, Henan, China, 450003
      • Not yet recruiting
      • Henan Cancer Hospital
  • Hubei
    • Xiangyang, Hubei, China, 441000
      • Not yet recruiting
      • Xiangyang Central Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • Not yet recruiting
      • Hunan Cancer Hospital
      • Principal Investigator: Yongzhong Luo
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Jiangsu Cancer Hospital
    • Wuxi, Jiangsu, China, 214000
      • Not yet recruiting
      • Affiliated Hospital of Jiangnan University
      • Principal Investigator: Yong Mao
    • Yangzhou, Jiangsu, China, 225001
      • Not yet recruiting
      • North Jiangsu People's Hospital
      • Principal Investigator: Lingfeng Min
  • Jilin
    • Changchun, Jilin, China, 130103
      • Not yet recruiting
      • Jilin Cancer Hospital
      • Principal Investigator: Ying Cheng
  • Shandong
    • Jinan, Shandong, China, 250000
      • Not yet recruiting
      • Affiliated Tumor Hospital of Shandong First Medical University
      • Principal Investigator: Baosheng Li
  • Yunan
    • Kunming, Yunan, China, 650106
      • Not yet recruiting
      • Yunnan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18~75 years old, both male and female
2. Stage 1: pathologically diagnosed, incurable NSCLC subjects who have failed standard treatment
3. Stage 2: have a histologically or cytologically confirmed diagnosis of relapsed or metastatic NSCLC; have not received prior systemic treatment for their recurrent or metastatic NSCLC; PD-L1 TPS <50% as confirmed by central laboratory
4. At least one measurable lesion based on RECIST v1.1 criteria
5. ECOG PS score: 0-1 points
6. Expected survival period ≥ 3 months
7. Good levels of organ function
8. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. Patients with EGFR activating mutation, positive ALK fusion gene or known ROS1 fusion gene
2. Untreated brain metastases; or associated with meningeal metastases, spinal cord compression, etc.
3. Uncontrolled pleural, pericardial, or ascites with clinical symptoms
4. Severe bone damage caused by tumor bone metastasis
5. Suffering from other malignant tumors in the past 3 years or at the same time
6. Presence of any active or known autoimmune disease
7. Systemic treatment with corticosteroids or other immunosuppressants within 2 weeks before the first dose
8. Have clinical symptoms or diseases of the heart that are not well controlled
9. Serious infection occurred within 1 month before the first dose
10. Past or current active interstitial lung disease requiring treatment, non-infectious pneumonia requiring glucocorticoid system treatment; current active pneumonia or pulmonary function test confirmed severe impairment of pulmonary function
11. With active pulmonary tuberculosis
12. Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known active viral hepatitis
13. Known history of inflammatory bowel disease
14. Inoculated with live attenuated vaccine within 28 days before the first dose
15. Known allergic reaction to other monoclonal antibodies
16. Received >30 Gy of pulmonary radiotherapy within 6 months before the first dose; received major surgical treatment, systemic chemotherapy, immunotherapy or other clinical trial drugs within 4 weeks before the first dose; within 2 weeks before the first dose Received palliative radiotherapy; oral molecularly targeted drugs, discontinued to less than 5 half-lives before first dose; failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE ≤1 degree
17. According to the judgment of the researcher, there are other factors that may affect the results of the study or cause the study to be terminated halfway.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-8068 in combination with adebrelimab	Drug: SHR-8068；Adebrelimab; SHR-8068: Sterile Injection, 50mg/10mL, Intravenous Infusion Adebrelimab: injection, 600mg/12mL, intravenous infusion
Experimental: SHR-8068 in combination with adebrelimab and platinum-based chemotherapy	Drug: SHR-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
Experimental: Adebrelimab in combination with platinum-based chemotherapy	Drug: Adebrelimab；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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose limiting toxicity	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;	up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease Control Rate, determined using RECIST v1.1 criteria	up to 2 years
Progression-Free-Survival assessed by investigator	up to 2 years

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Anticipated): June 30, 2026
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SHR-8068-II-201-NSCLC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No