Non-small cell lung cancer
Conditions
Interventions
Experimental Group:Neoadjuvant Phase: PD-L1/VEGF Bispecific Antibody: Intravenous administration, dose at RP2D, q3w for 3 cycles
Platinum- plus taxane-based chemotherapy: q3w for 3 cycles.
Local Treatment Phase: After 3 cycles, surgical candidates (assessed by contrast-enhanced CT and/or whole-body PET-CT plus MDT) undergo surg
non-surgical patients: treatment plan determined by MDT.
Adjuvant Phase: Adjuvant treatment plan determined by comprehensive MDT discussion.
Control Group:Neoadjuvant Phase: PD-1 Monoclonal Antibody: Intravenous administration, dose per drug package insert (standard dose), q3w for 3 cycles
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient shall sign the Informed Consent Form. 2. Aged 18 >= years. 3. 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. 4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1. 5. Life expectancy is at least 12 weeks. 6. At least 1 measurable lesion according to RECIST 1.1. 7. Adequate function of other major organs (liver, kidneys, hematologic system, etc.): (1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelets >= 100 × 10^9/L, hemoglobin >= 90 g/L. Note: Patients must not have received blood transfusion or growth factor support within = 120 days after the last dose, and must have a negative urine or serum pregnancy test result within <= 7 days before enrollment. 11. 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).
Exclusion criteria
Exclusion criteria: 1. Patients with lung adenocarcinoma with confirmed EGFR mutations or ALK rearrangements; 2. Histological evidence of small cell components; 3. Patients with other malignant tumors within five years prior to the start of this trial; 4. Having received any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment, and experimental treatment, etc.; 5. 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; 6. Active, known, or suspected autoimmune diseases, or autoimmune paraneoplastic syndromes requiring systemic treatment; 7. Allergy to the trial drug; 8. Currently diagnosed with interstitial lung disease; 9. Concomitant HIV infection or active hepatitis; 10. Pregnant or lactating women; 11. Patients with neurological or psychiatric disorders who are unable to cooperate; 12. Concurrently participating in another therapeutic clinical study; 13. Other situations deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response (PCR) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| major pathologic response (MPR);Obeject response rate (ORR);overall survival (OS);event-free survival (EFS);R0 Resection Rate;Health-Related Quality of Life (HRQoL); | — |
Countries
China
Contacts
Public ContactPeng Zhang
Shanghai Pulmonary Hospital
Outcome results
None listed