Using PD-1 Antibody with BACE for Advanced Lung Cancer Treatment

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

This study is testing if combining a PD-1 antibody treatment with a special chemo technique can help people with advanced lung cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Zhengzhou University (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, immunotherapy
• Locations: 8 sites (Guiyang, Guizhou and 7 other locations)
• Trial ID: NCT05605613 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to evaluate the efficacy and safety of combining PD-1 antibody therapy with Bronchial Arterial Chemoembolization (BACE) in patients with stage III-Ⅳ non-small cell lung cancer (NSCLC) who have either failed, refused, or are ineligible for standard treatments. BACE is a technique that delivers anti-tumor drugs directly to the tumor's blood supply, while PD-1 antibodies are designed to enhance the immune response against cancer cells. The study will assess how this combination impacts patient outcomes, particularly in terms of survival and disease progression. Participants will be monitored for both short-term and long-term effects of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with stage III-Ⅳ NSCLC who have not responded to or are ineligible for conventional therapies.

Not a fit: Patients with prior treatments targeting PD-1, PD-L1, or CTLA-4, or those with specific genetic mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced NSCLC who have limited alternatives.

How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors in NSCLC, suggesting potential for success with this combined approach.

Eligibility criteria

Inclusion Criteria:

1. Patient age between 18 and 75
2. Signed Informed Consent Form.
3. Confirmed TNM stage is III-Ⅳ 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

Where this trial is running

Guiyang, Guizhou and 7 other locations

• People's Hospital of Kaiyang County — Guiyang, Guizhou, China (Recruiting)
• North China University of Science and Technology Affiliated Hospital — Tangshan, Hebei, China (Recruiting)
• The Second Affiliated Hospital of Xingtai Medical College — Xingtai, Hebei, China (Recruiting)
• Hebi City Jun County People's Hospital — Hebi, Henan, China (Recruiting)
• Wuyang County People's Hospital — Luohe, Henan, China (Recruiting)
• Dengzhou People's Hospital — Nanyang, Henan, China (Recruiting)
• The Fifth People's Hospital of Puyang City — Puyang, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Xuhua Duan — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: XuHua Duan

Conditions NSCLC; BACE; PD-1 Antibody