Clinical trial NCT05416775: Phase Ib/II Study of SHR-8068 Injection in the Treatment of Advanced Non-small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Non-small Cell Lung Cancer
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-13
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: The observation period is 21 days after the first dose
measure: Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points;
timeFrame: up to 2 years
Secondary outcomes:
measure: Disease Control Rate, determined using RECIST v1.1 criteria
timeFrame: up to 2 years
measure: Progression-Free-Survival assessed by investigator
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Chest Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Chengdu
country: China
facility: West China Hospital Of Sichuan University
state: Chengdu
city: Chongqing
country: China
facility: Cancer Hospital Affiliated to Chongqing University
state: Chongqing
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi Zhuang Autonomous Region
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Yangzhou
country: China
facility: North Jiangsu People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Jinan
country: China
facility: Affiliated Tumor Hospital of Shandong First Medical University
state: Shandong
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunan
Study officials:
References: