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
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
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
China,
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 |
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