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
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
168 participants
Aug 15, 2022
INTERVENTIONAL
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
Inclusion Criteria8
- Age 18\~75 years old, both male and female
- Stage 1: pathologically diagnosed, incurable NSCLC subjects who have failed standard treatment
- 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
- At least one measurable lesion based on RECIST v1.1 criteria
- ECOG PS score: 0-1 points
- Expected survival period ≥ 3 months
- Good levels of organ function
- Patients voluntarily joined the study and signed informed consent
Exclusion Criteria17
- Patients with EGFR activating mutation, positive ALK fusion gene or known ROS1 fusion gene
- Untreated brain metastases; or associated with meningeal metastases, spinal cord compression, etc.
- Uncontrolled pleural, pericardial, or ascites with clinical symptoms
- Severe bone damage caused by tumor bone metastasis
- Suffering from other malignant tumors in the past 3 years or at the same time
- Presence of any active or known autoimmune disease
- Systemic treatment with corticosteroids or other immunosuppressants within 2 weeks before the first dose
- Have clinical symptoms or diseases of the heart that are not well controlled
- Serious infection occurred within 1 month before the first dose
- 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
- With active pulmonary tuberculosis
- Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known active viral hepatitis
- Known history of inflammatory bowel disease
- Inoculated with live attenuated vaccine within 28 days before the first dose
- Known allergic reaction to other monoclonal antibodies
- 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
- 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.
Interventions
SHR-8068: Sterile Injection, 50mg/10mL, Intravenous Infusion Adebrelimab: injection, 600mg/12mL, intravenous infusion
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: 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05416775