Status:
RECRUITING
Phase Ib/II Study of SHR-8068 Injection in the Treatment of Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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-ba...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05416775
Start Date
August 15 2022
End Date
June 30 2026
Last Update
August 19 2022
Active Locations (18)
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1
Anhui Chest Hospital
Hefei, Anhui, China, 230000
2
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
3
West China Hospital Of Sichuan University
Chengdu, Chengdu, China, 610000
4
Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China, 400030