About this trial
Surgical intervention remains the primary treatment option for early-stage lung cancer. With the proven efficacy of immunotherapy in the treatment of advanced non-small cell lung cancer (NSCLC), neoadjuvant immunotherapy has increasingly become a focal point of research. Blocking vascular endothelial growth factor (VEGF) not only inhibits the proliferation of vascular endothelial cells and the formation of new blood vessels but also improves the tumor microenvironment and enhances the infiltration of cytotoxic T lymphocytes within it. Simultaneously targeting the VEGF and PD-L1 pathways can create a synergistic anti-cancer effect. PM8002 injection is a bispecific antibody drug that targets both PD-L1 and VEGF, functioning as a dual-action agent that combines immune suppression and anti-angiogenesis. In patients with locally advanced stage II-III NSCLC, neoadjuvant therapy that concurrently targets PD-L1/VEGF in combination with chemotherapy can improve pathological response rates, provided that the safety of the drug combination is maintained. This approach offers additional benefits to patients, prolongs event-free survival (EFS), and improves prognosis.
Eligibility criteria
Qualifiers
The patient shall sign the Informed Consent Form.
Aged 18 ≥ years.
Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-III confirmed by imageological examinations (CT, PET-CT or EBUS),and have not previously received anti-tumor treatment.
Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
Disqualifiers
Patients with lung adenocarcinoma with confirmed EGFR mutations or ALK rearrangements;
Histological evidence of small cell components;
Patients with other malignant tumors within five years prior to the start of this trial;
Having received any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment, and experimental treatment, etc.;
Trial design
Treatments tested in this trial
- PM8002
- Sintilimab
- Nab-paclitaxel
- Carboplatin
- Surgery