Resectable non-small cell lung cancer
Conditions
Interventions
experimental group:adebrelimab in combination with apatinib plus chemotherapy
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18 Years to 70 Years, Males and Females; 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 3. Consent to the collection of tumor histological specimens required for the study and their application to related research; 4. Consent to undergo radical surgical treatment; 5. The thoracic surgeon determines there are no contraindications to surgery 6. Pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection.Staging should be per the 8th edition of the AJCC/UICC staging system ; 7. Participants must have a tumor tissue sample which may be fresh or archival if obtained within 6 months prior to enrollment; 8. Measurable disease according to RECIST version 1.1; 9. Pulmonary function tests should be conducted within one month prior to the first study treatment. If clinically indicated, the tests should be repeated during the screening period. 10. Adequate organ function; 11. Female subjects of childbearing potential must have a negative blood pregnancy test within one week prior to the first administration of the drug. 12. Participants must have signed written informed consent form ,and willing and able to comply with scheduled visits.
Exclusion criteria
Exclusion criteria: 1. Subjects known to be positive for EGFR mutation or ALK fusion; 2. Mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcomatoid carcinoma confirmed by histology or cytology; 3. Presence of malignant pleural effusion; 4. Previously received any anti-cancer treatment, including radiotherapy, chemotherapy, and immunotherapy; 5. Imaging shows tumor invasion into major blood vessels or unclear boundaries with blood vessels; or imaging shows any pulmonary cavities or necrotic lesions. 6. Patients with any active autoimmune diseases or a history of autoimmune diseases; 7. Patients with congenital or acquired immune function deficiencies; 8. Presence of uncontrollable third space effusion; 9. Routine urine test suggests urinary protein = (++), or 24-hour urinary protein quantity = 1g, or severe hepatorenal insufficiency, etc.; 10. Subjects who need systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days before the first drug administration; 11. Subjects who have used anti-cancer vaccines or other immunostimulatory anti-cancer drugs within 1 month before the first drug administration; 12. Subjects who have received systemic immunosuppressive therapy within 2 weeks before the first administration; or subjects who are expected to require systemic immunosuppressive drug treatment during the study treatment period. 13. Currently participating in other clinical studies; 14. Has an autoimmune disease 15. History of other malignant tumors, except for non-small cell lung cancer, within the past 5 years before screening; 16. Subjects known or suspected to have interstitial pneumonia; 17. Uncontrollable hypertension; 18. Subjects with severe cardiovascular and cerebrovascular diseases; 19. Complicated with severe infection within 4 weeks before the first drug administration; 20. Major surgery, open biopsy, or significant trauma within 28 days before enrollment; traumatic minor surgery within 7 days before the first drug administration; 21. Arterial/venous thrombotic events within the past 6 months; 22. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first drug administration; 23. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 24. Pregnant or lactating women; patients with reproductive capacity who are unwilling or unable to take effective contraception; 25. Known to have allergic reactions, hypersensitivity reactions, or intolerance to avelumab, apatinib, chemotherapy, or their excipients; 26. Subjects known to have a history of substance abuse, alcoholism, or drug addiction; 27. Any condition that the investigator considers may harm the subject or cause the subject to be unable to meet or fulfill the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic response rate;Event free survival;Overall survival;Objective response rate;adverse event;surgery complications;biomarker; | — |
Countries
China
Contacts
Public ContactCheng chao
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed