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

Prior treatment

• 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.;
• Concomitant unstable systemic diseases, including active infections, uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), unstable angina, angina that started within the last 3 months, congestive heart failure (≥New York Heart Association \[NYHA\] Class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring drug treatment, liver, kidney, or metabolic diseases;
• Concomitant HIV infection or active hepatitis;

Other illness

• Active, known, or suspected autoimmune diseases, or autoimmune paraneoplastic syndromes requiring systemic treatment;
• Allergy to the trial drug;
• Currently diagnosed with interstitial lung disease;
• Patients with neurological or psychiatric disorders who are unable to cooperate;

Lab values

• Patients with lung adenocarcinoma with confirmed EGFR mutations or ALK rearrangements;

Other

• Histological evidence of small cell components;
• Pregnant or lactating women;
• Concurrently participating in another therapeutic clinical study;
• Other situations deemed unsuitable for enrollment by the investigator.

• 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.
• Life expectancy is at least 12 weeks.
• At least 1 measurable lesion according to RECIST 1.1.
• Patients with good function of other main organs (liver, kidney, blood system, etc.)
• Patients with lung function can tolerate surgery;
• Without systematic metastasis (including M1a, M1b and M1c);
• Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
• Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later).