PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial

NSCLC Clinical Trial

Official title:

PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization in Patients With Non-Small-Cell Lung Cancer: A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605613
• Other study ID #: 20221030
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 29, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: November 2022
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: XuHua Duan
• Phone: +8613523402912
• Email: xuhuaduan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial to determine the efficacy and safety of PD-1 Antibody in addition to Bronchial Arterial Chemoembolization in stage III-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.

Description:

Bronchial artery chemoembolization (BACE) is a technique of drug delivery and embolization performed via injecting anti-tumor drugs with drug carriers and implanting the embolization agents into the tumor feeding artery, promoting the clinical outcomes of patients and providing a palliative treatment option for patients with NSCLC. while the short-term effect of BACE is good, it is easy to relapse and metastasize.

The rapid development of immunotherapy checkpoint inhibitors represented by PD-1/L1 monoclonal antibody has changed the treatment pattern of NSCLC. The publication of early research data repeatedly verified the long-term survival benefit characteristics of PD-1/L1 in NSCLC.

Based on this research and clinical practice, we designed this trial to determine the efficacy and safety of PD-1 antibody in addition to Bronchial Arterial Chemoembolization in stage III-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2025
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patient age between 18 and 75

2. Signed Informed Consent Form.

3. Confirmed TNM stage is III-? of NSCLC ,and failed, refused or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, chemotherapy ); Eastern Cooperative Oncology Group (ECOG) performance status = 1

4. Adequate hematologic and end-organ function.

5. Expected life span > 3 months.

6. Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells

Exclusion Criteria:

1. Prior treatment targeting PD-1, PD-L1 or CTLA-4.

2. Prior therapies of interventional therapy (I seed implantation, Ablation, BACE).

3. Harboring EGFR sensitizing mutation or ALK gene translocation

4. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.

5. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.

6. Symptomatic central nervous system metastasis

7. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.

8. Prior allogeneic stem cell transplantation or organ transplantation

9. Active autoimmune diseases or history of autoimmune diseases that may relapse.

10. With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications

11. Known to be hypersensitive to contrast agent;

12. Pregnant or breastfeeding women;

13. Other protocol defined Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• PD-1 Antibody
PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1

Device:
• BACE
Bronchial Arterial Chemoembolization

Locations

Country	Name	City	State
China	People's Hospital of Kaiyang County	Guiyang	Guizhou
China	Hebi City Jun County People's Hospital	Hebi	Henan
China	Wuyang County People's Hospital	Luohe	Henan
China	Dengzhou People's Hospital	Nanyang	Henan
China	The Fifth People's Hospital of Puyang City	Puyang	Henan
China	North China University of Science and Technology Affiliated Hospital	Tangshan	Hebei
China	The Second Affiliated Hospital of Xingtai Medical College	Xingtai	Hebei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Xuhua Duan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	Time from the first BACE treatment to either radiological progression or death	Time from the first BACE treatment to either radiological progression or death or up to 12 months]
Secondary	Objective response rate (ORR)	Proportion of patients with reduction in stable in tumor burden of a predefined amount	Time Frame: 2, 4, 6 months after the first BACE treatment, up to death or 12 months
Secondary	Disease control rate (DCR)	Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount	2, 4, 6 months after the first BACE treatment, up to death or 12 months
Secondary	Overall survival (OS)	ime from the first BACE treatment to death from any cause or the end of the study	1 years