A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC

This study is a phase II, single-arm study, 64 participants were enrolled as of 6 Feb 2024, and recruitment was completed.

Inclusion criteria

• Signed informed consent form before any trial-related processes.
• Age ≥ 18 years male or female.
• Have a histologically or cytologically confirmed stage IIIB/IIIC NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic non-squamous NSCLC (IV).
• with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment.
• EGFR-TKI resistance, confirmed by RECIST v1.1.
• have adequate organ function.
• The investigator confirms at least one measurable lesion according to RECIST v1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed.
• The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.

Exclusion criteria

• Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.
• Have other driving gene mutations that can obtain effective treatment.
• Have previously received systemic anti-tumor treatment other than EGFR-TKI for advanced non-squamous NSCLC.
• Have received systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drugs.
• Have received EGFR-TKI treatment, within 14 days prior to the first dose of study drugs
• Anticoagulant or thrombolytic agent within 10 days prior to the first dose of study drugs.
• Evidence and history of severe bleeding tendency or coagulation dysfunction.
• The toxicity of previous anti-tumor therapy has not been alleviated.
• Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis.
• Have suffered from the second primary active malignant tumor in the past 5 years.