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โ† Trials
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A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

RecruitingPhase 2Ages 18 Years - 75 YearsAllHunan Cancer Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Sugemalimab and Chemotherapy
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Where

1 site
Hunan Cancer Hospital
Changsha, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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