Neoadjuvant LDRT Combined With Durvalumab in Potentially Resectable Stage III NSCLC

This is an interventional treatment trial for Stage III Non-small Cell Lung Cancer Read More

Inclusion Criteria:

1. Aged 18 ≥ years.
2. Histological or cytological diagnosis of NSCLC by needle biopsy, and potentially resectable stage III confirmed by image logical examinations (CT, PET-CT or EBUS).
3. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
4. Life expectancy is at least 12 weeks.
5. At least 1 measurable lesion according to RECIST 1.1.
6. With the feasibility or anticipated feasibility after neoadjuvant therapy to receive radical surgery;
7. Patients with good function of other main organs (liver, kidney, blood system, etc.):

1) ANC count ≥1.5×10^9/L, platelet count ≥100×10^9/L，hemoglobin ≥90 g/L; 2) the international standard ratio of prothrombin time (INR) and prothrombin time (PT) < 1.5 times of upper limit of normal (ULN); 3) Partial thromboplastin time (APTT) ≤1.5×ULN; 4) Total bilirubin ≤1.5×ULN; 5) Alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor.

8. Patients with normal lung function can tolerate surgery; 9. Without systematic metastasis (including M1a, M1b and M1c); 10. The patient shall sign the Informed Consent Form.

Exclusion Criteria:

1. Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
2. Administration of any Chinese medicine against cancer before administration of the drug;
3. Participants with other cancer within five years before the start of this study;
4. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
5. With activate or suspectable autoimmune disease, or autoimmune para cancer syndrome requiring systemic treatment;
6. Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial;
7. Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg/ day of prednisone are permitted;
8. Participants who are allergic to the test drug or any auxiliary materials;
9. Participants with active hepatitis B, hepatitis C or HIV;
10. The vaccine was administered within 4 weeks of the start of the trial;
11. Participants who have undergone major surgery or severe trauma in other systems within 2 months before the start of this trial;
12. Pleural effusion, pericardial effusion or ascites that are not clinically controlled and require pleural puncture or abdominal puncture drainage within 2 weeks before inclusion;
13. The patients have active pia meningioma, uncontrolled or untreated brain metastases;
14. Pregnant or lactating women;
15. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
16. Participated in another therapeutic clinical study;
17. Other factors that researchers think it is not suitable for enrollment.