A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

Overview

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

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.