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

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416775
• Other study ID #: SHR-8068-II-201-NSCLC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 15, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2022
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Xin Xu
• Phone: 0518-82342973
• Email: xin.xu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital Of Sichuan University	Chengdu	Chengdu
China	Cancer Hospital Affiliated to Chongqing University	Chongqing	Chongqing
China	Guizhou Provincial People's Hospital	Guiyang	Guizhou
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Chest Hospital	Hefei	Anhui
China	Anhui Provincial Hospital	Hefei	Anhui
China	Affiliated Tumor Hospital of Shandong First Medical University	Jinan	Shandong
China	Yunnan Cancer Hospital	Kunming	Yunan
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi Zhuang Autonomous Region
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	North Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity		The observation period is 21 days after the first dose
Primary	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	Disease Control Rate, determined using RECIST v1.1 criteria		up to 2 years
Secondary	Progression-Free-Survival assessed by investigator		up to 2 years