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
1 other identifier
interventional
168
1 country
18
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2022
Longer than P75 for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
August 19, 2022
May 1, 2022
3.9 years
May 27, 2022
August 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Dose limiting toxicity
The observation period is 21 days after the first dose
Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points;
up to 2 years
Secondary Outcomes (2)
Disease Control Rate, determined using RECIST v1.1 criteria
up to 2 years
Progression-Free-Survival assessed by investigator
up to 2 years
Study Arms (3)
SHR-8068 in combination with adebrelimab
EXPERIMENTALSHR-8068 in combination with adebrelimab and platinum-based chemotherapy
EXPERIMENTALAdebrelimab in combination with platinum-based chemotherapy
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Anhui Chest Hospital
Hefei, Anhui, 230000, China
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
West China Hospital Of Sichuan University
Chengdu, Chengdu, 610000, China
Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, 400030, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530022, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563003, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000, China
North Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Jilin Cancer Hospital
Changchun, Jilin, 130103, China
Affiliated Tumor Hospital of Shandong First Medical University
Jinan, Shandong, 250000, China
Yunnan Cancer Hospital
Kunming, Yunan, 650106, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 13, 2022
Study Start
August 15, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
August 19, 2022
Record last verified: 2022-05