Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study ID
NCT06837948
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PM8002 — DRUG
    Specified dose on specified days.
  • Sintilimab — DRUG
    Specified dose on specified days.
  • Nab-paclitaxel — DRUG
    Specified dose on specified days.
  • Carboplatin — DRUG
    Specified dose on specified days.
  • Surgery — PROCEDURE
    Patients with resectable tumor after neoadjuvant therapy will be treated with surgery.

Study Details

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.

Key Dates

Start date
Feb 18, 2025
Status verified
Feb 2025
Primary completion
Dec 1, 2031
Completion
Dec 1, 2031

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Exploratory arm
    In this arm, 20 patients with locally advanced Non-small cell lung cancer will receive 4 circles of neoadjuvant PM8002 combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery.
  • Experimental: PM8002 arm
    Patients with locally advanced Non-small cell lung cancer will be randomized into this arm (70 patients) and receive 4 circles of neoadjuvant PM8002 combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery.
  • Active Comparator: Sintilimab arm
    Patients with locally advanced Non-small cell lung cancer will be randomized into this arm (70 patients) and receive 4 circles of neoadjuvant Sintilimab combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery.

Primary Outcome Measure

Pathologic complete response (PCR) rate [ Time Frame: Up to 30 months ]

Central Contacts