A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC
Carcinoma, Non-Small-Cell Lung
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring immunotherapy, chemotherapy, radiotherapy, surgery, 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: Histologically or cytologically confirmed mixed SCLC and NSCLC; Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.); Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC; Previous thoracic radiotherapy; Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose; Systemic immunostimulant therapy before the first dose; Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment; Subjects with autoimmune diseases; Other malignant tumors other than non-small cell lung cancer within 5 years before screening; Known or suspected interstitial pneumonia; Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function; Severe cardiovascular and cerebrovascular diseases; Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose; Arteriovenous thrombotic events within 3 months before the first dose; Positive HIV test; Active hepatitis B or C; Evidence of active tuberculosis infection within 1 year before the first dose; Serious infection within 4 weeks before the first dose; History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study; Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose; Previous or planned allogeneic bone marrow transplantation or solid organ transplantation; History of severe allergic reactions to other monoclonal antibodies/fusion proteins; Allergic to any component of the randomized treatment regimen; Female subjects who are pregnant, lactating, or planning to get pregnant during the study period; Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse; Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.
Sites / Locations
- Hunan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Interventional arm
Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.