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

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05416775
• Collaborator: (none)
• Enrollment: 168
• Locations: 18
• Arms: 3
• Anticipated Duration (Months): 46.5
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Non-small Cell Lung Cancer	Drug: SHR-8068；Adebrelimab; Drug: SHR-8068；adebrelimab and platinum-based chemotherapy; Drug: Adebrelimab；platinum-based chemotherapy	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 15, 2022
• Anticipated Primary Completion Date: Jun 30, 2026
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SHR-8068 in combination with adebrelimab	Drug: SHR-8068；Adebrelimab; SHR-8068: Sterile Injection, 50mg/10mL, Intravenous Infusion Adebrelimab: injection, 600mg/12mL, intravenous infusion
Experimental: SHR-8068 in combination with adebrelimab and platinum-based chemotherapy	Drug: SHR-8068；adebrelimab and platinum-based chemotherapy; 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
Experimental: Adebrelimab in combination with platinum-based chemotherapy	Drug: Adebrelimab；platinum-based chemotherapy; 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

Outcome Measures

Primary Outcome Measures

1. Dose limiting toxicity [The observation period is 21 days after the first dose]

2. 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 Outcome Measures

1. Disease Control Rate, determined using RECIST v1.1 criteria [up to 2 years]

2. Progression-Free-Survival assessed by investigator [up to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Chest Hospital	Hefei	Anhui	China	230000
2	Anhui Provincial Hospital	Hefei	Anhui	China	230000
3	West China Hospital Of Sichuan University	Chengdu	Chengdu	China	610000
4	Cancer Hospital Affiliated to Chongqing University	Chongqing	Chongqing	China	400030
5	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi Zhuang Autonomous Region	China	530022
6	Guizhou Provincial People's Hospital	Guiyang	Guizhou	China	550002
7	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou	China	563003
8	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	China	150081
9	Henan Cancer Hospital	Zhengzhou	Henan	China	450003
10	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
11	Xiangyang Central Hospital	Xiangyang	Hubei	China	441000
12	Hunan Cancer Hospital	Changsha	Hunan	China	410000
13	Jiangsu Cancer Hospital	Nanjing	Jiangsu	China	210009
14	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu	China	214000
15	North Jiangsu People's Hospital	Yangzhou	Jiangsu	China	225001
16	Jilin Cancer Hospital	Changchun	Jilin	China	130103
17	Affiliated Tumor Hospital of Shandong First Medical University	Jinan	Shandong	China	250000
18	Yunnan Cancer Hospital	Kunming	Yunan	China	650106

Sponsors and Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05416775
• Other Study ID Numbers: SHR-8068-II-201-NSCLC
• First Posted: Jun 13, 2022
• Last Update Posted: Aug 19, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Aug 19, 2022