Phase Ib/II Study of SHR-8068 Injection in the Treatment of Advanced Non-small Cell Lung Cancer

Phase 1

Recruiting

• Conditions: Advanced Non-small Cell Lung Cancer
• Interventions: Drug: Adebrelimab；platinum-based chemotherapy; Drug: SHR-8068；Adebrelimab; Drug: SHR-8068；adebrelimab and platinum-based chemotherapy

• Registration Number: NCT05416775
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-13
• Study Start: 2022-08-15
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-19
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adebrelimab in combination with platinum-based chemotherapy	Adebrelimab；platinum-based chemotherapy	-
SHR-8068 in combination with adebrelimab	SHR-8068；Adebrelimab	-
SHR-8068 in combination with adebrelimab and platinum-based chemotherapy	SHR-8068；adebrelimab and platinum-based chemotherapy	-

Primary Outcome Measures

Name	Time	Method
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
Dose limiting toxicity	The observation period is 21 days after the first dose

Secondary Outcome Measures

Name	Time	Method
Progression-Free-Survival assessed by investigator	up to 2 years
Disease Control Rate, determined using RECIST v1.1 criteria	up to 2 years

Trial Locations

Locations (18)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China

Anhui Chest Hospital; 🇨🇳 Hefei, Anhui, China

West China Hospital Of Sichuan University; 🇨🇳 Chengdu, Chengdu, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

Cancer Hospital Affiliated to Chongqing University; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi Zhuang Autonomous Region, China

Guizhou Provincial People's Hospital; 🇨🇳 Guiyang, Guizhou, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Xiangyang Central Hospital; 🇨🇳 Xiangyang, Hubei, China

North Jiangsu People's Hospital; 🇨🇳 Yangzhou, Jiangsu, China

Affiliated Hospital of Jiangnan University; 🇨🇳 Wuxi, Jiangsu, China

Yunnan Cancer Hospital; 🇨🇳 Kunming, Yunan, China

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, China

Affiliated Tumor Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China