Actively Recruiting
An Open-label, Multicenter Phase Ib/II Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy for Advanced Non-small Cell Lung Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2022-08-19
168
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of the drug SHR-8068 combined with adebrelimab, with or without platinum-based chemotherapy, in adults with advanced non-small cell lung cancer (NSCLC). This phase Ib/II clinical trial aims to assess how well these treatment combinations work and their side effects in patients with incurable or relapsed NSCLC who have either failed standard treatments or have not received previous systemic therapy for metastatic disease. The study includes three treatment groups: SHR-8068 with adebrelimab; SHR-8068 combined with adebrelimab and platinum-based chemotherapy; and adebrelimab with platinum-based chemotherapy. Treatments involve intravenous infusions of the study drugs and chemotherapy agents such as pemetrexed, paclitaxel, carboplatin, or cisplatin. The study is open-label and randomized, allowing researchers to compare these combinations over time. Participants will be monitored for dose-limiting toxicities during the first 21 days after treatment begins and followed for up to two years to assess tumor response using RECIST v1.1 criteria. Additional evaluations include disease control rate and progression-free survival. Regular assessments will include physical exams, imaging to measure tumor size, and laboratory tests to monitor overall health and side effects. The total participation duration may extend up to two years, including ongoing safety and effectiveness evaluations.
CONDITIONS
Brief 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 18 to 75 years, male or female
- Diagnosed with incurable non-small cell lung cancer who failed standard treatment (Stage 1) or with relapsed/metastatic NSCLC not previously treated systemically and PD-L1 TPS <50% (Stage 2)
- At least one measurable tumor lesion based on RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- Expected survival of 3 months or longer
- Good organ function levels
- Signed informed consent to join the study
You will not qualify if you...
- Having EGFR activating mutation, positive ALK fusion gene, or known ROS1 fusion gene
- Untreated brain metastases or complications like meningeal metastases or spinal cord compression
- Uncontrolled pleural, pericardial, or ascitic fluid with symptoms
- Severe bone damage from tumor 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
- Poorly controlled heart disease symptoms
- Serious infection within 1 month before first dose
- Active interstitial lung disease or severe lung impairment
- Active pulmonary tuberculosis
- Positive for HIV or active viral hepatitis
- History of inflammatory bowel disease
- Live attenuated vaccine within 28 days before first dose
- Known allergy to monoclonal antibodies
- Recent major treatments or radiotherapy within specified timeframes before first dose
- Any other condition that may affect study results or cause early termination as judged by the researcher
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days for initial dose-limiting toxicity observation; treatment and assessments continue up to 2 years
Participants receive SHR-8068 combined with adebrelimab and/or platinum-based chemotherapy as part of the study treatment.
Regular visits during treatment cycles and assessments up to 2 years
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
W
Weixia Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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