Non-small cell lung cancer
Conditions
Interventions
intervention group:After 2 cycles of neoadjuvant JS001 (3mg/kg Q2W, ivdrip), all participants will undergo curative resection of lung cancer.
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All participants are willing to sign their name and date on informed consent form. 2. All participants are willing to follow study protocol to arrange visit, receive therapy and lab test. 3. Male or female, at least 18 years old but no more than 70 years old. 4. ECOG-PS 0-1. 5. All participants are diagnosed as resectable stage IB (>3cm), II, IIIA (N2 lymph node involvement excluded) (AJCC TNM stage, 8th edition) NSCLC with pathological confirmation. 6. All participants are able to receive surgery with sufficient cardiopulmonary function, FEV1>=1.5L and DLCO>=80% prediction. 7. Measurable lesion according to RECIST VERSION 1.1. 8. All participants are willing to submit sufficient tumor biopsy sample for exploratory biomarker tests: (1) All biopsy sample must be fresh or within 3 months; Formalin fixed paraffin embedded (FFPE) block or tissue sections (slides) of tumor biopsy sample without staining must be submitted; pathology report are available. (2) Core biopsy, resection biopsy or incision biopsy are required. 9. Lab test: (1)WBC >= 2,000/mm3 (2)ANC >= 1000/mm3 (3)PLT >= 100,000/mm3 (4)Hemoglobin >= 100g/L (5)Serum creatinine = 40 mL/min (Cockcroft-Gault formula): Female CrCl =( (140 - age in years) x weight in kg x 0.85)/(72 x serum creatinine in mg/dL) Male CrCl = ((140 - age in years) x weight in kg x 1.00)/(72 x serum creatinine in mg/dL) (6)Total bilirubin <= 1.5 ULN(except Gilbert syndrome patients: Total bilirubin <= 3 ULN) (7)AST/ALT/ALP <= 3ULN.
Exclusion criteria
Exclusion criteria: 1. Unresectable locally advanced or metastatic disease. 2. EGFR mutation positive or ALK mutation positive. 3. Active, diagnosed or suspicious of auto-immune disease, except type 1 diabetes, hypothyroidism controlled by hormone replacement therapy, skin disease without systemic therapy (including leucoderma, psoriasis or hair loss) or other cured auto-immune disease. 4. Participants who require systemic glucocorticoid (daily dosage> 10mg prednisone) or other immunosuppressants within 14 days of neoadjuvant therapy; inhalant/local glucocorticoid or glucocorticoid replacement therapy (daily dosage> 10mg prednisone) are permitted. 5. Severe disease or disease that is not controlled. 6. Usage of immune checkpoint inhibitor or other antibody that targets T-cell regulatory pathway. 7. Usage of chemotherapy or other treatment of cancer. 8. Active malignant tumor within 3 years, except curable cancer (including basal or squamous skin cancer, superficial bladder cancer, prostate cancer, carcinoma in situ of cervix uteri or mammary gland). 9. Active hepatitis (HBsAg or HCV RNA positive). 10. HIV infected. 11. Allergy to the component of JS001. 12. Incarcerated (including incarceration due to mental or infectious disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence rate of JS001 related adverse event/ severe adverse event;completion rate of JS001 neoadjuvant therapy without significantly delaying surgery;radiological response rate per RECIST V1.1; | — |
Countries
China
Contacts
Public ContactLanjun Zhang
Department of Thoracic Surgery, Sun Yat-Sen University Cancer Center
Outcome results
None listed