Advanced Non-small Cell Lung Cancer
Conditions
Brief 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
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
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a multicenter, open-label, dose-finding and efficacy-expansion phase Ib/II study. The first stage is for dose finding, using modified 3+3 design; the second stage is for dose confirmation and efficacy expansion through randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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 |
Countries
China
Contacts
Primary ContactXin Xu
Backup ContactWeixia Li
Outcome results
None listed