Actively Recruiting
Phase Ib/II Study of SHR-8068 Injection in the Treatment of Advanced Non-small Cell Lung Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2022-08-19
168
Participants Needed
18
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase Ib/II Study of SHR-8068 Injection in the Treatment of Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, male or female
- Stage 1: Pathologically diagnosed incurable NSCLC with failure of standard treatment
- Stage 2: Histologically or cytologically confirmed relapsed or metastatic NSCLC without prior systemic treatment for recurrence or metastasis; PD-L1 TPS <50% confirmed by central laboratory
- At least one measurable lesion based on RECIST v1.1 criteria
- ECOG performance status score of 0-1
- Expected survival of 3 months or longer
- Adequate organ function
- Voluntarily signed informed consent to participate in the study
You will not qualify if you...
- Presence of EGFR activating mutation, ALK fusion gene, or known ROS1 fusion gene
- Untreated brain metastases or associated meningeal metastases or spinal cord compression
- Uncontrolled pleural, pericardial, or ascites with symptoms
- Severe bone damage from tumor bone metastasis
- Other malignant tumors within the past 3 years or currently
- Active or known autoimmune disease
- Systemic corticosteroid or immunosuppressant treatment within 2 weeks before first dose
- Uncontrolled heart conditions
- Serious infection within 1 month before first dose
- Past or current active interstitial lung disease requiring treatment, non-infectious pneumonia needing glucocorticoids, active pneumonia, or severe lung impairment
- Active pulmonary tuberculosis
- Known positive HIV or acquired immunodeficiency syndrome, active viral hepatitis
- History of inflammatory bowel disease
- Live attenuated vaccine within 28 days before first dose
- Known allergy to monoclonal antibodies
- Received >30 Gy lung radiotherapy within 6 months before first dose; major surgery, systemic chemotherapy, immunotherapy, or clinical trial drugs within 4 weeks before first dose; palliative radiotherapy within 2 weeks before first dose; oral targeted drugs discontinued less than 5 half-lives before first dose; unresolved toxicity or complications from previous treatments
- Any other factors that may affect study results or cause early termination as judged by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Anhui Chest Hospital
Hefei, Anhui, China, 230000
Not Yet Recruiting
2
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
Not Yet Recruiting
3
West China Hospital Of Sichuan University
Chengdu, Chengdu, China, 610000
Not Yet Recruiting
4
Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China, 400030
Not Yet Recruiting
5
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530022
Not Yet Recruiting
6
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Not Yet Recruiting
7
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563003
Not Yet Recruiting
8
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
9
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
10
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
11
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441000
Not Yet Recruiting
12
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
13
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
14
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China, 214000
Not Yet Recruiting
15
North Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225001
Not Yet Recruiting
16
Jilin Cancer Hospital
Changchun, Jilin, China, 130103
Not Yet Recruiting
17
Affiliated Tumor Hospital of Shandong First Medical University
Jinan, Shandong, China, 250000
Not Yet Recruiting
18
Yunnan Cancer Hospital
Kunming, Yunan, China, 650106
Not Yet Recruiting
Research Team
X
Xin Xu
CONTACT
W
Weixia Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here