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Recruiting NCT05605613

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

Conditions: NSCLC

Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE2, PHASE3
Enrollment: 150
Sponsor: Xuhua Duan

Location: China

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.

Eligibility Criteria

Inclusion Criteria:Patient age between 18 and 75Signed Informed Consent Form.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 ≤ 1Adequate hematologic and end-organ function.Expected life span > 3 months.Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cellsExclusion Criteria:Prior treatment targeting PD-1, PD-L1 or CTLA-4.Prior therapies of interventional therapy (I seed implantation, Ablation, BACE).Harboring EGFR sensitizing mutation or ALK gene translocationHistory of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.Symptomatic central nervous system metastasisKnown HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.Prior allogeneic stem cell transplantation or organ transplantationActive autoimmune diseases or history of autoimmune diseases that may relapse.With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medicationsKnown to be hypersensitive to contrast agent;Pregnant or breastfeeding women;Other protocol defined Inclusion/Exclusion criteria may apply

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05605613). StuddyBuddy aggregates publicly available trial information.