a trial of sugemalimab and chemotherapy in unresectable stage iii nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the goal of this phase ii, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (mdt)-guided radiotherapy or surgery in unresectable, stage iii non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: 1.18 to 75 years old, both male and female; 2.ecog score: 0-1; 3.histopathologically or cytologically confirmed, stage iii (ajcc 8th) non-small cell lung cancer; 4.multidisciplinary team (mdt) discussion confirmed unresectable disease but can be treated by curative radiotherapy; 5.measurable lesions available; 6.major organ function is basically normal; 7.estimated survival time is at least 6 months; 8.non-surgically sterile female subjects of childbearing age must have a negative serum hcg test before inclusion. exclusion criteria: 1. histologically or cytologically confirmed mixed sclc and nsclc; 2. subjects with driver gene mutations(egfr mutation, alk fusion, etc.); 3. previous systemic anti-tumor therapy including immune checkpoint inhibitors for nsclc; 4. previous thoracic radiotherapy; 5. subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose; 6. systemic immunostimulant therapy before the first dose; 7. systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment; 8. subjects with autoimmune diseases; 9. other malignant tumors other than non-small cell lung cancer within 5 years before screening; 10. known or suspected interstitial pneumonia; 11. other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function; 12. severe cardiovascular and cerebrovascular diseases; 13. clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose; 14. arteriovenous thrombotic events within 3 months before the first dose; 15. positive hiv test; 16. active hepatitis b or c; 17. evidence of active tuberculosis infection within 1 year before the first dose; 18. serious infection within 4 weeks before the first dose; 19. history of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study; 20. major surgeries other than diagnosis or biopsy within 28 days prior to the first dose; 21. previous or planned allogeneic bone marrow transplantation or solid organ transplantation; 22. history of severe allergic reactions to other monoclonal antibodies/fusion proteins; 23. allergic to any component of the randomized treatment regimen; 24. female subjects who are pregnant, lactating, or planning to get pregnant during the study period; 25. subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse; 26. presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.

Keywords: immunotherapy chemotherapy radiotherapy surgery non-small cell lung cancer